Trial Outcomes & Findings for A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test (NCT NCT04191668)
NCT ID: NCT04191668
Last Updated: 2021-03-30
Results Overview
The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.
COMPLETED
NA
106 participants
Through study completion, an average of 1 month.
2021-03-30
Participant Flow
Participant milestones
| Measure |
PSG and NightOwl
Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
106
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
For one participant, gender data could not be retrieved.
Baseline characteristics by cohort
| Measure |
PSG and NightOwl
n=73 Participants
Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
|
|---|---|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 15.3 • n=73 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=72 Participants • For one participant, gender data could not be retrieved.
|
|
Sex: Female, Male
Male
|
30 Participants
n=72 Participants • For one participant, gender data could not be retrieved.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
39 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 Participants
n=73 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=73 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
18 Participants
n=73 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
54 Participants
n=73 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported
|
1 Participants
n=73 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=73 Participants
|
|
BMI
|
32.6 kg/m^2
STANDARD_DEVIATION 8.2 • n=73 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 month.Population: The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.
The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.
Outcome measures
| Measure |
PSG and NightOwl
n=73 Participants
Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
|
|---|---|
|
Pearson Correlation Between the AHI
|
0.909 Correlation coefficient
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 month.Population: The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.
The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;
Outcome measures
| Measure |
PSG and NightOwl
n=73 Participants
Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
|
|---|---|
|
Pearson Correlation Between the TST
|
0.610 Correlation coefficient
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 month.Population: The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.
The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.
Outcome measures
| Measure |
PSG and NightOwl
n=73 Participants
Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
|
|---|---|
|
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
|
0.685 Ratio
|
Adverse Events
PSG and NightOwl
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place