Trial Outcomes & Findings for A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD (NCT NCT05655832)
NCT ID: NCT05655832
Last Updated: 2026-01-15
Results Overview
An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
77 participants
Primary outcome timeframe
Day 0(Baseline) and Day 8 to Day 14
Results posted on
2026-01-15
Participant Flow
Participant milestones
| Measure |
Calibration Cohort
Participants in this group did not have COPD and wore a Vivalink wearable device and were observed for a period of 2 weeks
|
COPD Cohort
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
67
|
|
Overall Study
COMPLETED
|
10
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Calibration Cohort
Participants in this group did not have COPD and wore a Vivalink wearable device and were observed for a period of 2 weeks
|
COPD Cohort
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months.
|
|---|---|---|
|
Overall Study
Not mentioned
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol non-compliance
|
0
|
1
|
Baseline Characteristics
A Study to Investigate the Association of Real-world Sensor-derived Biometric Data With Clinical Parameters and Patient-reported Outcomes for Monitoring Disease Activity in Patients With COPD
Baseline characteristics by cohort
| Measure |
Calibration Cohort
n=10 Participants
Participants in this group did not have COPD and wore a Vivalink wearable device and were observed for a period of 2 weeks
|
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
Total
n=77 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
n=14 Participants
|
67 years
n=10 Participants
|
66 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=14 Participants
|
37 Participants
n=10 Participants
|
45 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=14 Participants
|
30 Participants
n=10 Participants
|
32 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=14 Participants
|
67 Participants
n=10 Participants
|
77 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point
An activity flag is extracted from the accelerometer by Vivalink, by using a predefined threshold for adult movement. For stair climbing, first periodic movement was determined, by using frequency analysis on specific time windows, and generating a ratio to the total spectrum indicating periodic activity over a certain threshold.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity
Day 0
|
41.98 minutes
Standard Deviation 22.89
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Physical Activity
Day 8 to Day 14
|
58.93 minutes
Standard Deviation 33.026
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Heart rate is provided by Vivalink.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate
Day 0
|
86.4 beats per minute
Standard Deviation 7.953
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate
Day 8 to Day 14
|
81.26 beats per minute
Standard Deviation 9.237
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Heart rate variability reflecting differences in time intervals between 2 R-waves in the ECG (milliseconds) SDRR (Standard Deviation of Intervals between Heartbeats), SDNN (Standard Deviation of Intervals between Heartbeats, after removing abnormal Beats), SDNNI (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-h HRV Recording), and RMSSD (Mean of the Standard Deviations of all the NN intervals for each 5 min Segment of a 24-hour HRV Recording) and In(RMSDD)
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
SDRR: Day 0
|
26.83 milliseconds
Standard Deviation 11.37
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
SDRR: Day 8-14
|
23.34 milliseconds
Standard Deviation 10.867
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
SDNN: Day 0
|
58.71 milliseconds
Standard Deviation 47.79
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
SDNN: Day 8-14
|
52.82 milliseconds
Standard Deviation 39.419
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
SDNNI: Day 0
|
69.51 milliseconds
Standard Deviation 63.18
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
SDNNI: Day 8-14
|
63.18 milliseconds
Standard Deviation 33.537
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
RMSSD: Day 0
|
55.37 milliseconds
Standard Deviation 59.658
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
RMSSD: Day 8-14
|
53.73 milliseconds
Standard Deviation 73.024
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
In (RMSSD): Day 0
|
3.59 milliseconds
Standard Deviation 0.883
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (SDRR, SDNN, SDNNI, RMSSD, ln(RMSSD))
In (RMSSD): Day 8-14
|
3.51 milliseconds
Standard Deviation 0.813
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
pNN50 is the percentage of adjacent NN intervals that differ from each other by more than 50 milliseconds.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50)
Day 0
|
0.12 percentage
Standard Deviation 0.198
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (pNN50)
Day 8-14
|
0.11 percentage
Standard Deviation 0.197
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Baevsky's Stress Index is a heart rate variability (HRV) measure used to assess autonomic nervous system activity and physiological stress, especially in monitoring chronic obstructive pulmonary disease (COPD) exacerbations. It is calculated as: amplitude of the mode (AMo) divided by two times the mode (Mo) multiplied by the difference between the maximum and minimum RR intervals (MxDMn). AMo is the percentage of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the range of RR intervals. The index typically ranges from 50 to over 900. Lower values (50-150) indicate low stress and better autonomic balance, while higher values (above 500) reflect increased stress and sympathetic activity. Values above 900 are considered very high stress. This is a single composite score with no subscales; higher scores represent worse outcomes.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index)
Day 0
|
108.43 ratio
Standard Deviation 94.236
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (Stress Index)
Day 8-14
|
99.86 ratio
Standard Deviation 81.076
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)
LF: Day 0
|
320.32 hertz
Standard Deviation 456.411
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)
LF: Day 8-14
|
287.19 hertz
Standard Deviation 399.897
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)
HF: Day 0
|
646.3 hertz
Standard Deviation 1234.891
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF and HF)
HF: Day 8-14
|
612.6 hertz
Standard Deviation 1542.947
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Applying a Fast Fourier Transformation (FFT) or autoregressive (AR) modeling one can separate Heart rate variability (HRV) into its component ultra-low-frequency (ULF), very low frequency (VLF), Low-Frequency power (LF), and High-Frequency power (HF) rhythms that operate within different frequency ranges. Given in absolute values of power (milliseconds squared). LF power, low frequency power (0.04-0.15 Hz). HF power, high frequency power (0.15-0.40 Hz). LF/HF Ratio, spectral HRV index computed as (LF/HF).
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF)
LF/HF: Day 0
|
1.38 ratio
Standard Deviation 1.211
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Heart Rate Variability (LF/HF)
LF/HF: Day 8-14
|
1.51 ratio
Standard Deviation 1.204
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Temperature is provided by Vivalink. The value for temperature is derived by Vivalink from the display temperature and then calibrated using initial calibration values, in an IP protected process. The sensor temperature is considered only as a relative value to evaluate changes in the temperature, and not as an objective human body temperature value, meaning no thresholds relative to normal human body temperature are considered, and it will not be used as a marker for fever or hypothermia.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature
Day 0
|
36.77 celsius
Standard Deviation 1.155
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Temperature
Day 8 to 14
|
37.14 celsius
Standard Deviation 1.239
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Respiration rate is provided by Vivalink.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate
Day 8 to Day 14
|
20.92 breaths per minute
Standard Deviation 2.247
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Respiratory Rate
Day 0
|
21.42 breaths per minute
Standard Deviation 1.903
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Cough Frequency was provided by vivalink.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency
Day 0
|
56.82 count per day
Standard Deviation 48.46
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Cough Frequency
Day 8 to Day 14
|
72.46 count per day
Standard Deviation 58.62
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
The basis of the sleep pattern calculations is the self-reported bedtimes. With the same technique as the cough frequency prediction, inactivity signals can be predicted from the labeled data to improve the bedtime accuracy, and the changes in accelerometer (step detection algorithms) can be used to quantify the number of clear breaks in the sleep (standing up, strong cough, etc.).
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns
Day 0
|
8.7 hours
Standard Deviation 1.892
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Sleep Patterns
Day 8 to Day 14
|
8.48 hours
Standard Deviation 1.491
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consists of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Resting Heart Rate is provided by Vivalink.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate
Day 0
|
85.02 beats per minute
Standard Deviation 8.003
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Resting Heart Rate
Day 8 to Day 14
|
79.9 beats per minute
Standard Deviation 9.126
|
PRIMARY outcome
Timeframe: Day 0(Baseline) and Day 8 to Day 14Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Using the breathing signal one can determine the inspiration and expiration peaks. The difference between said peaks in milliseconds can be used to determine the ratio of inspiration (distance from lower point to next peak) vs expiration (distance from peak to next lower point).
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio
Day 0
|
0.96 ratio
Standard Deviation 0.078
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Inspiration vs Expiration Time Ratio
Day 8 to Day 14
|
0.98 ratio
Standard Deviation 0.068
|
PRIMARY outcome
Timeframe: Day 0(Basseline) and Day 8 to Day 14Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Count of the number of times the use of additional medication as a log activity is reported per day.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication
Day 0
|
0.37 count per day
Standard Deviation 0.714
|
|
Chronic Obstructive Pulmonary Disease (COPD) Exacerbations of Sensor-collected Parameters During Observation Period - Frequency of Additional Medication
Day 8 to Day 14
|
0.82 count per day
Standard Deviation 0.859
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Accuracy was calculated as (True Positives + True Negatives) / Total Population. True Positives (TP) are events correctly predicted as exacerbations. True Negatives (TN) are events correctly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Accuracy scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy
70-30
|
0.56 percentage of predictability
|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Accuracy
Random
|
0.56 percentage of predictability
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Precision was calculated as True Positives / (True Positives + False Positives). True Positives (TP) are events correctly predicted as exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Precision scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision
70-30
|
0.53 percentage of predictability
|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Precision
Random
|
0.62 percentage of predictability
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Recall was calculated as True Positives / (True Positives + False Negatives). True Positives (TP) are events correctly predicted as exacerbations. False Negatives (FN) are events incorrectly predicted as non-exacerbations. Total Population refers to the total number of events evaluated. Recall scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall
70-30
|
0.63 percentage of predictability
|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Recall
Random
|
0.46 percentage of predictability
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Specificity was calculated as True Negatives / (True Negatives + False Positives). True Negatives (TN) are events correctly predicted as non-exacerbations. False Positives (FP) are events incorrectly predicted as exacerbations. Total Population refers to the total number of events evaluated. Specificity scores reflect XGBoost algorithm performance using random and time-based 70/30 data splits. The values were calculated in form of percentage where 100% is the ideal scenario for perfect predictability.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity
70-30
|
0.53 percentage of predictability
|
|
Prediction of Moderate or Severe COPD Exacerbations by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates - Specificity
Random
|
0.63 percentage of predictability
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Participants health status and symptoms at baseline (Day 0) and study end will be measured as the summary score across items of the CAT questionnaire that consists of 8-items in which participants can choose a score from 0 to 5, for each visit.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Heart Rate
|
0.19 correlation coefficient
Interval -0.07 to 0.43
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Heart Rate
|
0.45 correlation coefficient
Interval 0.16 to 1.67
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Resting Heart Rate
|
0.19 correlation coefficient
Interval -0.07 to 0.43
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Resting Heart Rate
|
0.46 correlation coefficient
Interval 0.16 to 0.68
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Temperature
|
0.07 correlation coefficient
Interval -0.19 to 0.32
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Temperature
|
0.02 correlation coefficient
Interval -0.31 to 0.33
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Temperature (normalized)
|
0.12 correlation coefficient
Interval -0.14 to 0.36
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Temperature (normalized)
|
-0.13 correlation coefficient
Interval -0.43 to 0.2
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Respiration Rate
|
0.21 correlation coefficient
Interval -0.05 to 0.44
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Respiration Rate
|
0.3 correlation coefficient
Interval -0.02 to 0.57
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: SDRR
|
0.04 correlation coefficient
Interval -0.22 to 0.3
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: SDRR
|
0.39 correlation coefficient
Interval 0.08 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: SDNN
|
-0.06 correlation coefficient
Interval -0.31 to 0.21
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: SDNN
|
0.38 correlation coefficient
Interval 0.07 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: SDNNI
|
0.02 correlation coefficient
Interval -0.24 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: SDNNI
|
0.41 correlation coefficient
Interval 0.09 to 0.65
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: RMSSD
|
-0.04 correlation coefficient
Interval -0.29 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: RMSSD
|
0.42 correlation coefficient
Interval 0.12 to 0.66
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: In (RMSSD)
|
0.04 correlation coefficient
Interval -0.22 to 0.29
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: In (RMSSD)
|
0.44 correlation coefficient
Interval 0.14 to 0.67
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: pNN50
|
-0.06 correlation coefficient
Interval -0.31 to 0.2
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: pNN50
|
0.4 correlation coefficient
Interval 0.09 to 0.64
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Stress Index
|
-0.01 correlation coefficient
Interval -0.27 to 0.25
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Stress Index
|
-0.21 correlation coefficient
Interval -0.5 to 0.12
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: LF
|
-0.28 correlation coefficient
Interval -0.5 to -0.03
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: LF
|
0.15 correlation coefficient
Interval -0.19 to 0.45
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: HF
|
-0.09 correlation coefficient
Interval -0.34 to 0.17
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: HF
|
0.18 correlation coefficient
Interval -0.16 to 0.47
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: LF/HF
|
-0.12 correlation coefficient
Interval -0.36 to 0.15
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: LF/ HF
|
-0.34 correlation coefficient
Interval -0.6 to -0.01
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Physical Activity
|
-0.11 correlation coefficient
Interval -0.36 to 0.15
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Physical Activity
|
-0.11 correlation coefficient
Interval -0.42 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Physical Activity (normalized)
|
0.06 correlation coefficient
Interval -0.2 to 0.31
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Physical Activity (normalized)
|
0.11 correlation coefficient
Interval -0.22 to 0.42
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: In- vs. Expiration Time Ratio
|
-0.04 correlation coefficient
Interval -0.3 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: In- vs. Expiration Time Ratio
|
-0.21 correlation coefficient
Interval -0.5 to 0.12
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Cough Frequency
|
-0.2 correlation coefficient
Interval -0.43 to 0.06
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Cough Frequency
|
-0.21 correlation coefficient
Interval -0.5 to 0.12
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
Baseline: Cough Frequency (normalized)
|
0.06 correlation coefficient
Interval -0.2 to 0.31
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Participants Health Status and Symptoms at Baseline and Study End
End of Study: Cough Frequency (normalized)
|
0.27 correlation coefficient
Interval -0.06 to 0.55
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Lung function was assessed using plethysmography.
Outcome measures
| Measure |
COPD Cohort
n=39 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: pNN50
|
0.05 correlation coefficient
Interval -0.24 to 0.33
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: pNN50
|
-0.16 correlation coefficient
Interval -0.48 to 0.2
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Stress Index
|
-0.04 correlation coefficient
Interval -0.32 to 0.25
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Stress Index
|
-0.09 correlation coefficient
Interval -0.42 to 0.27
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: LF
|
0.35 correlation coefficient
Interval 0.07 to 0.58
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: LF
|
-0.11 correlation coefficient
Interval -0.44 to 0.25
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: HF
|
0.18 correlation coefficient
Interval -0.11 to 0.45
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: HF
|
-0.14 correlation coefficient
Interval -0.46 to 0.22
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: LF/HF
|
0.14 correlation coefficient
Interval -0.15 to 0.41
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: LF/ HF
|
0.04 correlation coefficient
Interval -0.32 to 0.38
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Physical Activity
|
0.11 correlation coefficient
Interval -0.18 to 0.39
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Physical Activity
|
-0.03 correlation coefficient
Interval -0.37 to 0.32
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Physical Activity (normalized)
|
-0.09 correlation coefficient
Interval -0.37 to 0.2
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Physical Activity (normalized)
|
-0.24 correlation coefficient
Interval -0.54 to 0.11
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: In- vs. Expiration Time Ratio
|
0.29 correlation coefficient
Interval 0.0 to 0.53
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: In- vs. Expiration Time Ratio
|
0.13 correlation coefficient
Interval -0.23 to 0.46
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Cough Frequency
|
0.18 correlation coefficient
Interval -0.11 to 0.45
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Cough Frequency
|
-0.05 correlation coefficient
Interval -0.39 to 0.3
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Cough Frequency (normalized)
|
0.02 correlation coefficient
Interval -0.27 to 0.3
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Cough Frequency (normalized)
|
-0.2 correlation coefficient
Interval -0.51 to 0.15
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: In (RMSSD)
|
0.02 correlation coefficient
Interval -0.27 to 0.3
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: In (RMSSD)
|
-0.17 correlation coefficient
Interval -0.49 to 0.19
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Heart Rate
|
0.07 correlation coefficient
Interval -0.23 to 0.35
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Heart Rate
|
-0.36 correlation coefficient
Interval -0.62 to -0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Resting Heart Rate
|
0.08 correlation coefficient
Interval -0.22 to 0.36
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Resting Heart Rate
|
-0.32 correlation coefficient
Interval -0.6 to 0.03
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Temperature
|
-0.29 correlation coefficient
Interval -0.54 to -0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Temperature
|
-0.12 correlation coefficient
Interval -0.45 to 0.23
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Temperature (normalized)
|
-0.18 correlation coefficient
Interval -0.45 to 0.11
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Temperature (normalized)
|
0.1 correlation coefficient
Interval -0.25 to 0.43
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: Respiration Rate
|
-0.25 correlation coefficient
Interval -0.5 to 0.04
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: Respiration Rate
|
-0.24 correlation coefficient
Interval -0.54 to 0.11
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: SDRR
|
-0.28 correlation coefficient
Interval -0.53 to 0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: SDRR
|
-0.31 correlation coefficient
Interval -0.6 to 0.04
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: SDNN
|
0.15 correlation coefficient
Interval -0.14 to 0.42
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: SDNN
|
-0.17 correlation coefficient
Interval -0.49 to 0.19
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: SDNNI
|
-0.02 correlation coefficient
Interval -0.31 to 0.27
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: SDNNI
|
-0.25 correlation coefficient
Interval -0.55 to 0.11
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
Baseline: RMSSD
|
0.08 correlation coefficient
Interval -0.21 to 0.36
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1) at Baseline and Study End
End of Study: RMSSD
|
-0.19 correlation coefficient
Interval -0.5 to 0.17
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Lung function was assessed using plethysmography.
Outcome measures
| Measure |
COPD Cohort
n=39 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Heart Rate
|
0.11 correlation coefficient
Interval -0.18 to 0.38
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Heart Rate
|
-0.15 correlation coefficient
Interval -0.47 to 0.21
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Resting Heart Rate
|
0.13 correlation coefficient
Interval -0.16 to 0.4
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Resting Heart Rate
|
-0.11 correlation coefficient
Interval -0.44 to 0.24
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Temperature
|
-0.21 correlation coefficient
Interval -0.47 to 0.08
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Temperature
|
-0.28 correlation coefficient
Interval -0.57 to 0.07
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Temperature (normalized)
|
-0.32 correlation coefficient
Interval -0.55 to -0.03
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Temperature (normalized)
|
-0.1 correlation coefficient
Interval -0.43 to 0.25
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Respiration Rate
|
-0.28 correlation coefficient
Interval -0.52 to 0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Respiration Rate
|
-0.09 correlation coefficient
Interval -0.42 to 0.26
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: SDRR
|
-0.2 correlation coefficient
Interval -0.46 to 0.09
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: SDRR
|
-0.04 correlation coefficient
Interval -0.38 to 0.31
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: SDNN
|
0.16 correlation coefficient
Interval -0.13 to 0.43
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: SDNN
|
0.09 correlation coefficient
Interval -0.27 to 0.43
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: SDNNI
|
0.03 correlation coefficient
Interval -0.26 to 0.31
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: SDNNI
|
0.04 correlation coefficient
Interval -0.31 to 0.38
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: RMSSD
|
0.1 correlation coefficient
Interval -0.19 to 0.38
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: RMSSD
|
0.19 correlation coefficient
Interval -0.17 to 0.5
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: In (RMSSD)
|
0.04 correlation coefficient
Interval -0.25 to 0.32
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: In (RMSSD)
|
0.03 correlation coefficient
Interval -0.32 to 0.38
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: pNN50
|
0.07 correlation coefficient
Interval -0.22 to 0.35
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: pNN50
|
0.21 correlation coefficient
Interval -0.15 to 0.52
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Stress Index
|
-0.09 correlation coefficient
Interval -0.36 to 0.21
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Stress Index
|
0.25 correlation coefficient
Interval -0.11 to 0.55
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: LF
|
0.31 correlation coefficient
Interval 0.02 to 0.55
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: LF
|
0.29 correlation coefficient
Interval -0.06 to 0.58
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: HF
|
0.15 correlation coefficient
Interval -0.14 to 0.42
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: HF
|
0.32 correlation coefficient
Interval -0.04 to 0.6
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: LF/HF
|
0.25 correlation coefficient
Interval -0.04 to 0.5
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: LF/ HF
|
0.04 correlation coefficient
Interval -0.32 to 0.38
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Physical Activity
|
0.02 correlation coefficient
Interval -0.27 to 0.3
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Physical Activity
|
0.11 correlation coefficient
Interval -0.24 to 0.44
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Physical Activity (normalized)
|
-0.07 correlation coefficient
Interval -0.35 to 0.22
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Physical Activity (normalized)
|
0.09 correlation coefficient
Interval -0.26 to 0.42
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: In- vs. Expiration Time Ratio
|
0.22 correlation coefficient
Interval -0.07 to 0.48
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: In- vs. Expiration Time Ratio
|
0.02 correlation coefficient
Interval -0.33 to 0.36
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Cough Frequency
|
0.16 correlation coefficient
Interval -0.13 to 0.43
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Cough Frequency
|
-0.16 correlation coefficient
Interval -0.47 to 0.2
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
Baseline: Cough Frequency (normalized)
|
0.12 correlation coefficient
Interval -0.17 to 0.4
|
|
Correlation of Sensor-Collected Data With Lung Function (FVC) at Baseline and Study End
End of Study: Cough Frequency (normalized)
|
0.06 correlation coefficient
Interval -0.28 to 0.4
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Here, "Number analyzed" signifies those participants who were evaluable at specified time point.
Lung function was assessed using plethysmography.
Outcome measures
| Measure |
COPD Cohort
n=39 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Heart Rate
|
-0.07 correlation coefficient
Interval -0.35 to 0.22
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Heart Rate
|
-0.3 correlation coefficient
Interval -0.59 to 0.04
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Resting Heart Rate
|
-0.08 correlation coefficient
Interval -0.36 to 0.21
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Resting Heart Rate
|
-0.29 correlation coefficient
Interval -0.58 to 0.05
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Temperature
|
-0.16 correlation coefficient
Interval -0.43 to 0.14
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Temperature
|
0.15 correlation coefficient
Interval -0.2 to 0.47
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Temperature (normalized)
|
0.07 correlation coefficient
Interval -0.22 to 0.35
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Temperature (normalized)
|
0.28 correlation coefficient
Interval -0.07 to 0.57
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Respiration Rate
|
0 correlation coefficient
Interval -0.29 to 0.28
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Respiration Rate
|
-0.22 correlation coefficient
Interval -0.52 to 0.14
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: SDRR
|
-0.27 correlation coefficient
Interval -0.51 to 0.02
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: SDRR
|
-0.42 correlation coefficient
Interval -0.67 to -0.08
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: SDNN
|
-0.08 correlation coefficient
Interval -0.36 to 0.21
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: SDNN
|
-0.28 correlation coefficient
Interval -0.57 to 0.08
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: SDNNI
|
-0.17 correlation coefficient
Interval -0.44 to 0.12
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: SDNNI
|
-0.35 correlation coefficient
Interval -0.63 to -0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: RMSSD
|
-0.09 correlation coefficient
Interval -0.37 to 0.2
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: RMSSD
|
-0.36 correlation coefficient
Interval -0.63 to -0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: In (RMSSD)
|
-0.13 correlation coefficient
Interval -0.4 to 0.16
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: In (RMSSD)
|
-0.23 correlation coefficient
Interval -0.53 to 0.13
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: pNN50
|
-0.09 correlation coefficient
Interval -0.37 to 0.2
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: pNN50
|
-0.33 correlation coefficient
Interval -0.61 to 0.02
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Stress Index
|
0.09 correlation coefficient
Interval -0.2 to 0.37
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Stress Index
|
-0.31 correlation coefficient
Interval -0.59 to 0.05
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: LF
|
0.07 correlation coefficient
Interval -0.22 to 0.35
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: LF
|
-0.31 correlation coefficient
Interval -0.59 to 0.05
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: HF
|
0.02 correlation coefficient
Interval -0.27 to 0.31
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: HF
|
-0.36 correlation coefficient
Interval -0.63 to -0.01
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: LF/HF
|
-0.06 correlation coefficient
Interval -0.34 to 0.23
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: LF/ HF
|
0.03 correlation coefficient
Interval -0.33 to 0.37
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Physical Activity
|
0.2 correlation coefficient
Interval -0.09 to 0.46
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Physical Activity
|
-0.15 correlation coefficient
Interval -0.47 to 0.2
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Physical Activity (normalized)
|
-0.02 correlation coefficient
Interval -0.31 to 0.26
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Physical Activity (normalized)
|
-0.37 correlation coefficient
Interval -0.64 to -0.03
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: In- vs. Expiration Time Ratio
|
0.2 correlation coefficient
Interval -0.09 to 0.46
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: In- vs. Expiration Time Ratio
|
0.17 correlation coefficient
Interval -0.19 to 0.49
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Cough Frequency
|
-0.02 correlation coefficient
Interval -0.31 to 0.27
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Cough Frequency
|
0.1 correlation coefficient
Interval -0.25 to 0.43
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
Baseline: Cough Frequency (normalized)
|
-0.18 correlation coefficient
Interval -0.44 to 0.12
|
|
Correlation of Sensor-Collected Data With Lung Function (FEV1/FVC) at Baseline and Study End
End of Study: Cough Frequency (normalized)
|
-0.29 correlation coefficient
Interval -0.57 to 0.06
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Heart Rate
|
0.2 correlation coefficient
Interval -0.25 to 0.58
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Heart Rate
|
-0.07 correlation coefficient
Interval -0.5 to 0.39
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Resting Heart Rate
|
0.21 correlation coefficient
Interval -0.24 to 0.59
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Resting Heart Rate
|
-0.04 correlation coefficient
Interval -0.47 to 0.41
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Temperature
|
0.19 correlation coefficient
Interval -0.26 to 0.58
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Temperature
|
0.34 correlation coefficient
Interval -0.12 to 0.68
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Temperature (normalized)
|
-0.29 correlation coefficient
Interval -0.64 to 0.16
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Temperature (normalized)
|
0.38 correlation coefficient
Interval -0.08 to 0.7
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Respiration Rate
|
0.42 correlation coefficient
Interval -0.02 to 0.72
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Respiration Rate
|
-0.06 correlation coefficient
Interval -0.49 to 0.4
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: SDRR
|
0.12 correlation coefficient
Interval -0.33 to 0.53
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: SDRR
|
-0.01 correlation coefficient
Interval -0.46 to 0.44
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: SDNN
|
0.22 correlation coefficient
Interval -0.24 to 0.59
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: SDNN
|
0.21 correlation coefficient
Interval -0.27 to 0.61
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: SDNNI
|
0.28 correlation coefficient
Interval -0.17 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: SDNNI
|
0.12 correlation coefficient
Interval -0.35 to 0.55
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: RMSSD
|
0.31 correlation coefficient
Interval -0.14 to 0.65
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: RMSSD
|
0.25 correlation coefficient
Interval -0.23 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: In (RMSSD)
|
0.25 correlation coefficient
Interval -0.2 to 0.62
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: In (RMSSD)
|
0.32 correlation coefficient
Interval -0.16 to 0.68
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: pNN50
|
0.4 correlation coefficient
Interval -0.04 to 0.71
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: pNN50
|
0.34 correlation coefficient
Interval -0.14 to 0.69
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Stress Index
|
0.02 correlation coefficient
Interval -0.42 to 0.45
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Stress Index
|
-0.23 correlation coefficient
Interval -0.62 to 0.25
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: LF
|
-0.1 correlation coefficient
Interval -0.51 to 0.35
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: LF
|
0.37 correlation coefficient
Interval -0.1 to 0.71
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: HF
|
-0.1 correlation coefficient
Interval -0.51 to 0.35
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: HF
|
0.42 correlation coefficient
Interval -0.04 to 0.74
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: LF/HF
|
-0.07 correlation coefficient
Interval -0.49 to 0.37
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: LF/ HF
|
-0.3 correlation coefficient
Interval -0.66 to 0.18
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Physical Activity
|
-0.41 correlation coefficient
Interval -0.72 to 0.02
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Physical Activity
|
-0.19 correlation coefficient
Interval -0.59 to 0.27
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Physical Activity (normalized)
|
-0.36 correlation coefficient
Interval -0.68 to 0.09
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Physical Activity (normalized)
|
0.13 correlation coefficient
Interval -0.33 to 0.54
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: In- vs. Expiration Time Ratio
|
-0.17 correlation coefficient
Interval -0.56 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: In- vs. Expiration Time Ratio
|
-0.05 correlation coefficient
Interval -0.49 to 0.41
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Cough Frequency
|
0.02 correlation coefficient
Interval -0.41 to 0.45
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Cough Frequency
|
0.26 correlation coefficient
Interval -0.21 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
Baseline: Cough Frequency (normalized)
|
-0.27 correlation coefficient
Interval -0.63 to 0.19
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (White Blood Cells Count)
End of Study: Cough Frequency (normalized)
|
-0.31 correlation coefficient
Interval -0.66 to 0.15
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Heart Rate
|
0.01 correlation coefficient
Interval -0.43 to 0.44
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Heart Rate
|
0.11 correlation coefficient
Interval -0.35 to 0.53
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Resting Heart Rate
|
0.02 correlation coefficient
Interval -0.41 to 0.45
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Resting Heart Rate
|
0.1 correlation coefficient
Interval -0.36 to 0.52
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Temperature
|
0.48 correlation coefficient
Interval 0.06 to 0.75
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Temperature
|
0.21 correlation coefficient
Interval -0.25 to 0.6
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Temperature (normalized)
|
0.08 correlation coefficient
Interval -0.36 to 0.5
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Temperature (normalized)
|
0.02 correlation coefficient
Interval -0.43 to 0.46
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Respiration Rate
|
-0.23 correlation coefficient
Interval -0.6 to 0.23
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Respiration Rate
|
-0.14 correlation coefficient
Interval -0.55 to 0.32
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: SDRR
|
0.11 correlation coefficient
Interval -0.34 to 0.51
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: SDRR
|
0.39 correlation coefficient
Interval -0.08 to 0.72
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: SDNN
|
0.17 correlation coefficient
Interval -0.29 to 0.56
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: SDNN
|
0.41 correlation coefficient
Interval -0.05 to 0.73
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: SDNNI
|
0.24 correlation coefficient
Interval -0.21 to 0.61
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: SDNNI
|
0.43 correlation coefficient
Interval -0.02 to 0.74
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: RMSSD
|
0.13 correlation coefficient
Interval -0.32 to 0.53
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: RMSSD
|
0.25 correlation coefficient
Interval -0.23 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: In (RMSSD)
|
0.04 correlation coefficient
Interval -0.4 to 0.46
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: In (RMSSD)
|
0.28 correlation coefficient
Interval -0.2 to 0.65
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: pNN50
|
0.08 correlation coefficient
Interval -0.37 to 0.49
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: pNN50
|
0.41 correlation coefficient
Interval -0.05 to 0.73
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Stress Index
|
-0.11 correlation coefficient
Interval -0.52 to 0.34
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Stress Index
|
-0.32 correlation coefficient
Interval -0.67 to 0.16
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: LF
|
0.08 correlation coefficient
Interval -0.36 to 0.49
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: LF
|
0.3 correlation coefficient
Interval -0.18 to 0.66
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: HF
|
0.24 correlation coefficient
Interval -0.22 to 0.61
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: HF
|
0.13 correlation coefficient
Interval -0.34 to 0.55
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: LF/HF
|
0.25 correlation coefficient
Interval -0.2 to 0.62
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: LF/ HF
|
0.16 correlation coefficient
Interval -0.32 to 0.57
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Physical Activity
|
-0.26 correlation coefficient
Interval -0.62 to 0.2
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Physical Activity
|
-0.05 correlation coefficient
Interval -0.48 to 0.4
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Physical Activity (normalized)
|
-0.16 correlation coefficient
Interval -0.55 to 0.3
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Physical Activity (normalized)
|
0.13 correlation coefficient
Interval -0.33 to 0.54
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: In- vs. Expiration Time Ratio
|
-0.34 correlation coefficient
Interval -0.68 to 0.1
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: In- vs. Expiration Time Ratio
|
-0.21 correlation coefficient
Interval -0.61 to 0.27
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Cough Frequency
|
-0.53 correlation coefficient
Interval -0.78 to -0.13
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Cough Frequency
|
-0.06 correlation coefficient
Interval -0.49 to 0.4
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
Baseline: Cough Frequency (normalized)
|
0.24 correlation coefficient
Interval -0.21 to 0.61
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Erythrocytes Count)
End of Study: Cough Frequency (normalized)
|
0.4 correlation coefficient
Interval 0.0 to 0.74
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Heart Rate
|
-0.39 correlation coefficient
Interval -0.68 to 0.01
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Heart Rate
|
-0.3 correlation coefficient
Interval -0.65 to 0.15
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Resting Heart Rate
|
-0.41 correlation coefficient
Interval -0.69 to -0.01
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Resting Heart Rate
|
-0.3 correlation coefficient
Interval -0.65 to 0.15
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Temperature
|
-0.3 correlation coefficient
Interval -0.62 to 0.11
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Temperature
|
-0.24 correlation coefficient
Interval -0.61 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Temperature (normalized)
|
0.02 correlation coefficient
Interval -0.38 to 0.41
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Temperature (normalized)
|
-0.07 correlation coefficient
Interval -0.49 to 0.37
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Respiration Rate
|
-0.54 correlation coefficient
Interval -0.77 to -0.19
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Respiration Rate
|
-0.3 correlation coefficient
Interval -0.65 to 0.15
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: SDRR
|
-0.32 correlation coefficient
Interval -0.64 to 0.09
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: SDRR
|
-0.27 correlation coefficient
Interval -0.64 to 0.21
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: SDNN
|
-0.13 correlation coefficient
Interval -0.5 to 0.29
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: SDNN
|
-0.15 correlation coefficient
Interval -0.56 to 0.33
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: SDNNI
|
-0.2 correlation coefficient
Interval -0.56 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: SDNNI
|
-0.22 correlation coefficient
Interval -0.61 to 0.26
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: RMSSD
|
-0.16 correlation coefficient
Interval -0.53 to 0.26
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: RMSSD
|
-0.08 correlation coefficient
Interval -0.51 to 0.39
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: In (RMSSD)
|
-0.24 correlation coefficient
Interval -0.52 to 0.18
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: In (RMSSD)
|
-0.27 correlation coefficient
Interval -0.64 to 0.21
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: pNN50
|
-0.14 correlation coefficient
Interval -0.52 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: pNN50
|
-0.26 correlation coefficient
Interval -0.64 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Stress Index
|
-0.27 correlation coefficient
Interval -0.61 to 0.15
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Stress Index
|
0.37 correlation coefficient
Interval -0.1 to 0.71
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: LF
|
-0.04 correlation coefficient
Interval -0.44 to 0.37
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: LF
|
-0.35 correlation coefficient
Interval -0.7 to 0.12
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: HF
|
-0.09 correlation coefficient
Interval -0.48 to 0.32
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: HF
|
-0.17 correlation coefficient
Interval -0.58 to 0.31
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: LF/HF
|
0.2 correlation coefficient
Interval -0.22 to 0.56
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: LF/ HF
|
-0.17 correlation coefficient
Interval -0.58 to 0.31
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Physical Activity
|
0.47 correlation coefficient
Interval 0.09 to 0.73
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Physical Activity
|
-0.05 correlation coefficient
Interval -0.47 to 0.39
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Physical Activity (normalized)
|
0.24 correlation coefficient
Interval -0.18 to 0.58
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Physical Activity (normalized)
|
-0.17 correlation coefficient
Interval -0.56 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: In- vs. Expiration Time Ratio
|
0.34 correlation coefficient
Interval -0.08 to 0.65
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: In- vs. Expiration Time Ratio
|
0.28 correlation coefficient
Interval -0.2 to 0.65
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Cough Frequency
|
0.16 correlation coefficient
Interval -0.25 to 0.52
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Cough Frequency
|
0.24 correlation coefficient
Interval -0.21 to 0.61
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
Baseline: Cough Frequency (normalized)
|
0.03 correlation coefficient
Interval -0.37 to 0.42
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Oxygen (pO2))
End of Study: Cough Frequency (normalized)
|
-0.28 correlation coefficient
Interval -0.63 to 0.17
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Heart Rate
|
0.16 correlation coefficient
Interval -0.25 to 0.52
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Heart Rate
|
0.32 correlation coefficient
Interval -0.13 to 0.66
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Resting Heart Rate
|
0.18 correlation coefficient
Interval -0.23 to 0.54
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Resting Heart Rate
|
0.3 correlation coefficient
Interval -0.16 to 0.64
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Temperature
|
0.13 correlation coefficient
Interval -0.28 to 0.5
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Temperature
|
-0.26 correlation coefficient
Interval -0.62 to 0.2
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Temperature (normalized)
|
0.54 correlation coefficient
Interval 0.18 to 0.77
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Temperature (normalized)
|
-0.55 correlation coefficient
Interval -0.8 to -0.16
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Respiration Rate
|
0.09 correlation coefficient
Interval -0.31 to 0.47
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Respiration Rate
|
0.15 correlation coefficient
Interval -0.3 to 0.55
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: SDRR
|
-0.04 correlation coefficient
Interval -0.43 to 0.37
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: SDRR
|
0.14 correlation coefficient
Interval -0.33 to 0.56
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: SDNN
|
-0.13 correlation coefficient
Interval -0.51 to 0.29
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: SDNN
|
-0.12 correlation coefficient
Interval -0.55 to 0.35
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: SDNNI
|
-0.16 correlation coefficient
Interval -0.53 to 0.26
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: SDNNI
|
-0.04 correlation coefficient
Interval -0.49 to 0.42
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: RMSSD
|
-0.14 correlation coefficient
Interval -0.51 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: RMSSD
|
-0.32 correlation coefficient
Interval -0.67 to 0.16
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: In (RMSSD)
|
-0.21 correlation coefficient
Interval -0.56 to 0.21
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: In (RMSSD)
|
-0.29 correlation coefficient
Interval -0.66 to 0.19
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: pNN50
|
-0.14 correlation coefficient
Interval -0.52 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: pNN50
|
-0.14 correlation coefficient
Interval -0.56 to 0.34
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Stress Index
|
0.45 correlation coefficient
Interval 0.06 to 0.72
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Stress Index
|
0.14 correlation coefficient
Interval -0.34 to 0.56
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: LF
|
-0.24 correlation coefficient
Interval -0.58 to 0.18
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: LF
|
-0.4 correlation coefficient
Interval -0.72 to 0.07
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: HF
|
-0.1 correlation coefficient
Interval -0.48 to 0.32
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: HF
|
-0.5 correlation coefficient
Interval -0.78 to -0.06
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: LF/HF
|
-0.04 correlation coefficient
Interval -0.43 to 0.37
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: LF/ HF
|
0.23 correlation coefficient
Interval -0.25 to 0.62
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Physical Activity
|
-0.41 correlation coefficient
Interval -0.69 to -0.02
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Physical Activity
|
0.01 correlation coefficient
Interval -0.42 to 0.44
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Physical Activity (normalized)
|
-0.13 correlation coefficient
Interval -0.5 to 0.28
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Physical Activity (normalized)
|
0.2 correlation coefficient
Interval -0.26 to 0.58
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: In- vs. Expiration Time Ratio
|
-0.3 correlation coefficient
Interval -0.63 to 0.11
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: In- vs. Expiration Time Ratio
|
-0.27 correlation coefficient
Interval -0.65 to 0.21
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Cough Frequency
|
-0.27 correlation coefficient
Interval -0.6 to 0.14
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Cough Frequency
|
0.15 correlation coefficient
Interval -0.3 to 0.54
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
Baseline: Cough Frequency (normalized)
|
0 correlation coefficient
Interval -0.4 to 0.39
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (Partial Pressure of Carbon Dioxide (pCO2))
End of Study: Cough Frequency (normalized)
|
0.32 correlation coefficient
Interval -0.13 to 0.66
|
SECONDARY outcome
Timeframe: Baseline (Day 0) and at 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Lung function was assessed using plethysmography and lab values including Complete Blood Count with differential, Blood Gas Analysis, procalcitonin and CRP will be assessed as per standard practice at baseline (Day 0) and at study end
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Heart Rate
|
-0.33 correlation coefficient
Interval -0.64 to 0.09
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Heart Rate
|
-0.32 correlation coefficient
Interval -0.66 to 0.13
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Resting Heart Rate
|
-0.35 correlation coefficient
Interval -0.66 to 0.06
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Resting Heart Rate
|
-0.33 correlation coefficient
Interval -0.67 to 0.12
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Temperature
|
-0.29 correlation coefficient
Interval -0.62 to 0.13
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Temperature
|
0.03 correlation coefficient
Interval -0.41 to 0.45
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Temperature (normalized)
|
-0.28 correlation coefficient
Interval -0.61 to 0.14
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Temperature (normalized)
|
0.04 correlation coefficient
Interval -0.4 to 0.46
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Respiration Rate
|
-0.28 correlation coefficient
Interval -0.61 to 0.14
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Respiration Rate
|
-0.28 correlation coefficient
Interval -0.64 to 0.17
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: SDRR
|
-0.46 correlation coefficient
Interval -0.73 to -0.06
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: SDRR
|
-0.37 correlation coefficient
Interval -0.7 to 0.11
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: SDNN
|
-0.13 correlation coefficient
Interval -0.51 to 0.3
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: SDNN
|
-0.35 correlation coefficient
Interval -0.69 to 0.13
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: SDNNI
|
-0.22 correlation coefficient
Interval -0.58 to 0.21
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: SDNNI
|
-0.39 correlation coefficient
Interval -0.72 to 0.08
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: RMSSD
|
-0.11 correlation coefficient
Interval -0.5 to 0.32
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: RMSSD
|
-0.3 correlation coefficient
Interval -0.66 to 0.18
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: In (RMSSD)
|
-0.22 correlation coefficient
Interval -0.58 to 0.22
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: In (RMSSD)
|
-0.36 correlation coefficient
Interval -0.7 to 0.11
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: pNN50
|
-0.03 correlation coefficient
Interval -0.43 to 0.39
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: pNN50
|
-0.3 correlation coefficient
Interval -0.66 to 0.18
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Stress Index
|
-0.36 correlation coefficient
Interval -0.68 to 0.06
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Stress Index
|
0.13 correlation coefficient
Interval -0.34 to 0.55
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: LF
|
0.1 correlation coefficient
Interval -0.32 to 0.49
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: LF
|
-0.11 correlation coefficient
Interval -0.54 to 0.36
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: HF
|
-0.1 correlation coefficient
Interval -0.49 to 0.33
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: HF
|
-0.16 correlation coefficient
Interval -0.57 to 0.32
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: LF/HF
|
0.29 correlation coefficient
Interval -0.14 to 0.63
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: LF/ HF
|
-0.02 correlation coefficient
Interval -0.47 to 0.44
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Physical Activity
|
0.44 correlation coefficient
Interval 0.04 to 0.72
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Physical Activity
|
0.1 correlation coefficient
Interval -0.34 to 0.51
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Physical Activity (normalized)
|
0.17 correlation coefficient
Interval -0.25 to 0.53
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Physical Activity (normalized)
|
-0.07 correlation coefficient
Interval -0.48 to 0.38
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: In- vs. Expiration Time Ratio
|
0.45 correlation coefficient
Interval 0.04 to 0.73
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: In- vs. Expiration Time Ratio
|
0.41 correlation coefficient
Interval -0.06 to 0.73
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Cough Frequency
|
0.04 correlation coefficient
Interval -0.37 to 0.44
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Cough Frequency
|
0.28 correlation coefficient
Interval -0.17 to 0.64
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
Baseline: Cough Frequency (normalized)
|
-0.11 correlation coefficient
Interval -0.5 to 0.3
|
|
Correlation of Sensor-Collected Data With COPD Assessment Test (CAT) Questionnaire: Lung Function and Lab Values at Baseline and Study End (O2 Saturation)
End of Study: Cough Frequency (normalized)
|
-0.32 correlation coefficient
Interval -0.66 to 0.13
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
Exacerbations are classified as mild if they are treated with short-acting bronchodilators only, moderate if they are treated additionally with antibiotics or oral corticosteroids, or severe if the patient visits the emergency room or requires hospitalization because of an exacerbation.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Correlation of Sensor-Collected Data With Number, Date of Onset, and Duration of Mild, Moderate, and Severe Exacerbations
|
NA correlation coefficient
Data was not evaluable due to low number of exacerbations.
|
SECONDARY outcome
Timeframe: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Heart Rate and Resting Heart Rate). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score
7days<S/M E:Heart Rate
|
0.039 scores on a scale/beats per minute
Interval 0.016 to 0.063
|
|
Association Between Sensor Parameters (Heart Rate and Resting Heart Rate) and CAT Score
7days<S/M E:Resting Heart Rate
|
0.039 scores on a scale/beats per minute
Interval 0.015 to 0.063
|
SECONDARY outcome
Timeframe: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Respiration Rate). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (Respiration Rate) and CAT Score
7days<S/M E:Respiration Rate
|
0.370 scores on a scale/ breaths per minute
Interval 0.161 to 0.58
|
|
Association Between Sensor Parameters (Respiration Rate) and CAT Score
14days<S/M E:RespirationRate
|
0.789 scores on a scale/ breaths per minute
Interval 0.389 to 1.188
|
SECONDARY outcome
Timeframe: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
7days<S/M E:SDRR
|
0.030 scores on a scale/millimeter
Interval 0.01 to 0.051
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
7days<S/M E:SDNN
|
0.010 scores on a scale/millimeter
Interval 0.003 to 0.0171
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
14days<S/M E:SDNN
|
0.029 scores on a scale/millimeter
Interval 0.01 to 0.048
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
7days<S/M E:SDNNI
|
0.011 scores on a scale/millimeter
Interval 0.003 to 0.018
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
14days<S/M E:SDNNI
|
0.045 scores on a scale/millimeter
Interval 0.021 to 0.069
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
7days<S/M E:RMSSD
|
0.006 scores on a scale/millimeter
Interval 0.003 to 0.01
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
14days<S/M E:RMSSD
|
0.016 scores on a scale/millimeter
Interval 0.004 to 0.027
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
7days<S/M E:In (RMSSD)
|
0.576 scores on a scale/millimeter
Interval 0.204 to 0.948
|
|
Association Between Sensor Parameters (SDRR, SDNN, SDNNI, RMSSD, In(RMSSD)) and CAT Score
14days<S/M E:In(RMSSD)
|
1.893 scores on a scale/millimeter
Interval 1.006 to 2.781
|
SECONDARY outcome
Timeframe: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period, participants completed the CAT questionnaire daily via a digital app. Stress Index, based on heart rate variability (HRV), assessed autonomic activity and physiological stress. It was calculated as AMo/(2 \* Mo \* MxDMn), where AMo is the % of RR intervals at the most frequent value, Mo is the most common RR interval, and MxDMn is the RR interval range. Stress Index values range from 50-900; lower values (50-150) indicate low stress and better autonomic balance, while higher values (\>500) reflect increased stress and sympathetic activity. LF power reflects sympathetic activity; HF power reflects parasympathetic activity. Linear mixed models assessed associations between CAT score and each sensor parameters. Fixed effect estimates represent change in CAT score per unit change in each parameter. Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI".
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score
7days<S/M E:Stress Index
|
0.003 fixed effect estimate
Interval 0.0 to 0.007
|
|
Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score
14days<S/M E:StressIndex
|
-0.006 fixed effect estimate
Interval -0.011 to 0.0
|
|
Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score
7days<S/M E:LF/HF
|
-0.441 fixed effect estimate
Interval -0.703 to -0.179
|
|
Association Between Sensor Parameters (Stress Index, LF/HF) and CAT Score
14days<S/M E:LF/HF
|
-0.963 fixed effect estimate
Interval -1.762 to -0.164
|
SECONDARY outcome
Timeframe: 7 days before Severe/Moderate Excarbations(S/M E) (7-day window period) and 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (pNN50). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (pNN50) and CAT Score
7days<S/M E:pNN50
|
2.259 scores on a scale/percent of heartbeats
Interval 0.956 to 3.561
|
|
Association Between Sensor Parameters (pNN50) and CAT Score
14days<S/M E:pNN50
|
5.483 scores on a scale/percent of heartbeats
Interval 0.723 to 10.242
|
SECONDARY outcome
Timeframe: 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Temperature). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (Temperature) and CAT Score
|
0.943 scores on a scale/degree Celsius
Interval 0.047 to 1.839
|
SECONDARY outcome
Timeframe: 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Physical activity). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (Physical Activity) and CAT Score
|
-0.016 scores on a scale/minute
Interval -0.031 to 0.0
|
SECONDARY outcome
Timeframe: 14 days before S/M E (1 day window period)Population: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria.
During the observation period the CAT score was obtained via a digital application daily. The daily CAT questionnaire summary score was computed. The fixed effect estimate represents the change in CAT score per unit change in the corresponding parameter. Linear mixed models were performed to assess the association between the CAT score and each sensor parameter (Sleep pattern). Data was calculated through linear mixed model; reported as "fixed effect estimate" with measure type as "number" and measure dispersion as "95% CI."
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Association Between Sensor Parameters (Sleep Pattern) and CAT Score
|
-0.292 scores on a scale/hours per day
Interval -0.571 to -0.014
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: COPD cohort consisted of all participants with COPD fulfilling all of the inclusion criteria and none of the exclusion criteria. Data was not derived due to low number of exacerbations.
Patients' health status and symptoms at baseline (Day 0) were measured using the CAT questionnaire, an 8-item tool with scores ranging from 0 to 5 per item. CAT scores were collected daily via a digital application during the observation period. Various machine learning algorithms were evaluated for predictive performance using metrics including accuracy, specificity, sensitivity, precision, positive predictive value (PPV), negative predictive value (NPV), and area under the ROC curve. R² (coefficient of determination) was computed for CAT score prediction models, defined as R² = 1 - (SS\_res / SS\_tot), where SS\_res is the residual sum of squares and SS\_tot is the total sum of squares. R² values range from 0 to 1, with higher values indicating better model fit.
Outcome measures
| Measure |
COPD Cohort
n=67 Participants
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|
|
Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates
Time-Split Model
|
82.7 coefficient of determination (R^2)
|
|
Predicting the CAT Score by Building a Statistical Model Employing Sensor-Derived Data and Demographic and Medical Covariates
XGBoost regressor model
|
82.6 coefficient of determination (R^2)
|
Adverse Events
Calibration Cohort
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
COPD Cohort
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Calibration Cohort
n=67 participants at risk
Participants in this group did not have COPD and wore a Vivalink wearable device and were observed for a period of 2 weeks
|
COPD Cohort
n=67 participants at risk
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
3.0%
2/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
1.5%
1/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
Other adverse events
| Measure |
Calibration Cohort
n=67 participants at risk
Participants in this group did not have COPD and wore a Vivalink wearable device and were observed for a period of 2 weeks
|
COPD Cohort
n=67 participants at risk
Participants in this group wore a Vivalink wearable device and were observed for a period of 3 months
|
|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
1.5%
1/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
3.0%
2/67 • Up to 3 months
No AEs were documented for the calibration cohort and 6 AEs were reported in the COPD cohort
|
Additional Information
Communication Center
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Phone: +49-6151-72-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place