Trial Outcomes & Findings for HHHFA in COPD Patients, With Chronic Bronchitis (NCT NCT03959982)
NCT ID: NCT03959982
Last Updated: 2024-09-19
Results Overview
Pittsburgh Sleep Quality Index (PSQI) Questionnaires will be done at baseline and completion of study. This questionnaire will be used to collect information regarding the subject's usual sleep habits during the past month. PSQI: Pittsburgh Sleep Quality Index ranges from 0 to 21 with highest scores indicating worse sleep quality. Values presented here indicate the change between baseline and 6 weeks. Positive values indicate worse sleep quality at 6 weeks.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Baseline and 6 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
HHHFA Device: Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
|---|---|---|
|
Overall Study
STARTED
|
8
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
HHHFA Randomized Group
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
HHHFA Device: Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Control Group
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
HHHFA in COPD Patients, With Chronic Bronchitis
Baseline characteristics by cohort
| Measure |
HHHFA Randomized Group
n=4 Participants
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
HHHFA Device: Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Control Group
n=3 Participants
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
58 Years
n=5 Participants
|
61 Years
n=7 Participants
|
59 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6 weeksPittsburgh Sleep Quality Index (PSQI) Questionnaires will be done at baseline and completion of study. This questionnaire will be used to collect information regarding the subject's usual sleep habits during the past month. PSQI: Pittsburgh Sleep Quality Index ranges from 0 to 21 with highest scores indicating worse sleep quality. Values presented here indicate the change between baseline and 6 weeks. Positive values indicate worse sleep quality at 6 weeks.
Outcome measures
| Measure |
HHHFA Randomized Group
n=4 Participants
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
HHHFA Device: Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Control Group
n=3 Participants
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
|---|---|---|
|
Sleep Quality Using the PSQI Questionnaire
|
-0.5 score on a scale
Interval -1.5 to 0.5
|
1 score on a scale
Interval -2.5 to 1.0
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksChange in 6 minute walk distance. 6 min walk: distance covered during 6 min walk in meters. Greater values indicate better exercise capacity.
Outcome measures
| Measure |
HHHFA Randomized Group
n=4 Participants
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
HHHFA Device: Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Control Group
n=3 Participants
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
|---|---|---|
|
6 Minute Walk
|
20 meters
Interval -11.0 to 45.0
|
1.5 meters
Interval -28.0 to 14.0
|
SECONDARY outcome
Timeframe: Baseline and 6 weeksCOPD Assessment Test (CAT) Questionnaires will be done at baseline and completion of study. This questionnaire will collect information regarding the subject's belief on the impact COPD is having on the wellbeing and daily life. CAT: COPD Assessment Test ranges from 0 to 40. Values presented here indicate the change between baseline and 6 weeks. Higher scores indicate worse quality of life due to COPD at 6 weeks.
Outcome measures
| Measure |
HHHFA Randomized Group
n=4 Participants
Subjects will be randomized to use the HHHFA device during bedtime for at least 4 hours. Subjects will complete MRC, SGRQ, CAT, CASA-Q and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
HHHFA Device: Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
Control Group
n=3 Participants
Subjects will complete MRC, SGRQ, CAT, and PSQI questionnaires. They will do spirometry, 6-minute walk, and CT scan. These interventions will be done at baseline and at the completion of their study (6 weeks). Spirehealth Device will be worn by subject daily for 12 weeks.
Spirometry: Pre and post spirometry using albuterol.
6-minute walk: 6-minute walk
CT scan: CT scan
Medical Research Council dyspnea scale (MRC): MRC questionnaire
St. George's Respiratory Questionnaire (SGRQ): SGRQ questionnaire
COPD Assessment Test (CAT): CAT questionnaire
Pittsburgh Sleep Quality Index (PSQI): PSQI questionnaire
CASA-Q: CASA-Q questionnaire
Spirehealth Tag Device: Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
|
|---|---|---|
|
Health Related Quality of Life Change Using the CAT Questionnaire
|
0 score on a scale
Interval -0.25 to 1.25
|
-7 score on a scale
Interval -9.0 to -3.0
|
Adverse Events
HHHFA Randomized Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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