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=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	90 Participants n=5 Participants	104 Participants n=7 Participants	194 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	9 Participants n=7 Participants	15 Participants n=5 Participants
Age, Continuous	46.3 years STANDARD_DEVIATION 11.8 • n=5 Participants	48.1 years STANDARD_DEVIATION 12.6 • n=7 Participants	47.27 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	8 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Male	83 Participants n=5 Participants	105 Participants n=7 Participants	188 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	26 Participants n=7 Participants	40 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	15 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) White	54 Participants n=5 Participants	62 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	96 participants n=5 Participants	113 participants n=7 Participants	209 participants n=5 Participants
Apnea-Hypopnea Index	24.5 Events per hour STANDARD_DEVIATION 21.6 • n=5 Participants	26.3 Events per hour STANDARD_DEVIATION 23.2 • n=7 Participants	25.5 Events per hour STANDARD_DEVIATION 22.4 • n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Measurement 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: carl.stepnowsky@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place