Trial Outcomes & Findings for Self-Management of Continuous Positive Airway Pressure Settings (NCT NCT03536572)
NCT ID: NCT03536572
Last Updated: 2024-09-19
Results Overview
Measurement of the amount of time that CPAP is used on average per night over the outcome time frame
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
270 participants
Primary outcome timeframe
2 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Sleep Apnea Self-Management Program
Protocol-based sleep apnea and CPAP education and support
Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
|
Individualized Pressure Adjustment
Additional education and support that will allow them to adjust their PAP pressures
Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
136
|
|
Overall Study
COMPLETED
|
96
|
113
|
|
Overall Study
NOT COMPLETED
|
38
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-Management of Continuous Positive Airway Pressure Settings
Baseline characteristics by cohort
| Measure |
Sleep Apnea Self-Management Program
n=96 Participants
Protocol-based sleep apnea and CPAP education and support
Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
|
Individualized Pressure Adjustment
n=113 Participants
Additional education and support that will allow them to adjust their PAP pressures
Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
|
Total
n=209 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
90 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
194 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Age, Continuous
|
46.3 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
48.1 years
STANDARD_DEVIATION 12.6 • n=107 Participants
|
47.27 years
STANDARD_DEVIATION 12.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
188 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=99 Participants
|
62 Participants
n=107 Participants
|
116 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=99 Participants
|
113 participants
n=107 Participants
|
209 participants
n=206 Participants
|
|
Apnea-Hypopnea Index
|
24.5 Events per hour
STANDARD_DEVIATION 21.6 • n=99 Participants
|
26.3 Events per hour
STANDARD_DEVIATION 23.2 • n=107 Participants
|
25.5 Events per hour
STANDARD_DEVIATION 22.4 • n=206 Participants
|
PRIMARY outcome
Timeframe: 2 monthsMeasurement of the amount of time that CPAP is used on average per night over the outcome time frame
Outcome measures
| Measure |
Sleep Apnea Self-Management Program
n=96 Participants
Protocol-based sleep apnea and CPAP education and support
Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
|
Individualized Pressure Adjustment
n=113 Participants
Additional education and support that will allow them to adjust their PAP pressures
Sleep Apnea Self-Management Program: Protocol-based sleep apnea and CPAP education and support
|
|---|---|---|
|
Treatment Adherence
|
2.1 Hours per night
Standard Deviation 1.5
|
2.2 Hours per night
Standard Deviation 1.6
|
Adverse Events
Sleep Apnea Self-Management Program
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Individualized Pressure Adjustment
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
Carl J. Stepnowky, Deputy ACOS R&D
VA San Diego Healthcare System
Phone: 858-642-3269
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place