Trial Outcomes & Findings for Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial (NCT NCT06039865)
NCT ID: NCT06039865
Last Updated: 2026-08-03
Results Overview
Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3), which was 35 days after randomization.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
5 weeks
Results posted on
2026-08-03
Participant Flow
Participant milestones
| Measure |
Immediate Intervention
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Immediate Intervention: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
|
Waitlist Control
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
Waitlist control: Participants only receive usual care from the sleep center.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chronic Care Management With Wearable Devices in Patients Prescribed Positive Airway Pressure Therapy (mPAP) Trial
Baseline characteristics by cohort
| Measure |
Immediate Intervention
n=25 Participants
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Immediate Intervention: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
|
Waitlist Control
n=25 Participants
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
Waitlist control: Participants only receive usual care from the sleep center.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.4 years
STANDARD_DEVIATION 12.4 • n=20 Participants
|
45.4 years
STANDARD_DEVIATION 9.9 • n=20 Participants
|
47.9 years
STANDARD_DEVIATION 11.4 • n=40 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=20 Participants
|
23 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
18 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=20 Participants
|
17 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=20 Participants
|
25 participants
n=20 Participants
|
50 participants
n=40 Participants
|
PRIMARY outcome
Timeframe: 5 weeksChange in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3), which was 35 days after randomization.
Outcome measures
| Measure |
Immediate Intervention
n=25 Participants
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Immediate Intervention: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
|
Waitlist Control
n=25 Participants
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
Waitlist control: Participants only receive usual care from the sleep center.
|
|---|---|---|
|
Change in PAP Adherence (Minutes) From Baseline to Post-treatment (T3)
|
79.8 minutes per night
Interval 32.5 to 127.4
|
-10.2 minutes per night
Interval -57.5 to 37.4
|
SECONDARY outcome
Timeframe: 5 weeksChange in the days PAP was used \>= 4 hours from baseline (T1) to post-treatment (T3), which occurred 35 days after randomization.
Outcome measures
| Measure |
Immediate Intervention
n=25 Participants
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Immediate Intervention: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
|
Waitlist Control
n=25 Participants
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
Waitlist control: Participants only receive usual care from the sleep center.
|
|---|---|---|
|
Change in PAP Adherence (Days Used >= 4 Hours) From Baseline to Post-treatment (T3)
|
1.32 days
Interval 0.51 to 2.13
|
0.12 days
Interval -0.69 to 0.93
|
Adverse Events
Immediate Intervention
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Immediate Intervention
n=25 participants at risk
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Immediate Intervention: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
|
Waitlist Control
n=25 participants at risk
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
Waitlist control: Participants only receive usual care from the sleep center.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Hospitalization for skin infection
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from baseline to follow up, which was approximately 11 weeks.
|
0.00%
0/25 • Adverse event data were collected from baseline to follow up, which was approximately 11 weeks.
|
Other adverse events
| Measure |
Immediate Intervention
n=25 participants at risk
Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.
Immediate Intervention: Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.
|
Waitlist Control
n=25 participants at risk
Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.
Waitlist control: Participants only receive usual care from the sleep center.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
rash
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected from baseline to follow up, which was approximately 11 weeks.
|
16.0%
4/25 • Number of events 4 • Adverse event data were collected from baseline to follow up, which was approximately 11 weeks.
|
|
Skin and subcutaneous tissue disorders
bruise
|
0.00%
0/25 • Adverse event data were collected from baseline to follow up, which was approximately 11 weeks.
|
4.0%
1/25 • Number of events 1 • Adverse event data were collected from baseline to follow up, which was approximately 11 weeks.
|
Additional Information
Dr. Constance Fung, Principal Investigator
VA Greater Los Angeles Healthcare System
Phone: 8188917711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place