Trial Outcomes & Findings for Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk (NCT NCT01944020)

NCT ID: NCT01944020

Last Updated: 2022-05-03

Results Overview

Fat mass (% of total body mass) measured via BODPOD at baseline preceding treatment phase, and at the end of treatment phase.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: At baseline ("Pre") and after 2 months of treatment ("Post") or control
• Results posted on: 2022-05-03

Participant Flow

Participant milestones

Measure	Intervention - CPAP Use Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months	Control - No CPAP Use Control will be no use of CPAP for 2 months
Overall Study STARTED	17	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Measure	Intervention - CPAP Use Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months	Control - No CPAP Use Control will be no use of CPAP for 2 months
Overall Study Withdrawal by Subject	5	0

Baseline Characteristics

Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk

Baseline characteristics by cohort

Measure	Intervention - CPAP Use n=12 Participants Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months	Control - No CPAP Use n=12 Participants Control will be no use of CPAP for 2 months	Total n=24 Participants Total of all reporting groups
Age, Continuous	47.7 years STANDARD_DEVIATION 10.9 • n=5 Participants	53.1 years STANDARD_DEVIATION 11.6 • n=7 Participants	50.4 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic	5 Participants n=5 Participants	0 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Black Non-Hispanic	4 Participants n=5 Participants	8 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized Asian Non-Hispanic	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	12 participants n=7 Participants	24 participants n=5 Participants
Body mass index	35.6 kg/m^2 STANDARD_DEVIATION 4 • n=5 Participants	34.9 kg/m^2 STANDARD_DEVIATION 6.5 • n=7 Participants	35.2 kg/m^2 STANDARD_DEVIATION 5.2 • n=5 Participants

PRIMARY outcome

Timeframe: At baseline ("Pre") and after 2 months of treatment ("Post") or control

Population: all completed CPAP group and non-CPAP group participants

Fat mass (% of total body mass) measured via BODPOD at baseline preceding treatment phase, and at the end of treatment phase.

Outcome measures

Measure	Intervention - CPAP Use n=12 Participants Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months	Control - No CPAP Use n=12 Participants Control will be no use of CPAP for 2 months
Fat Mass (% of Total Body Mass) Pre (i.e., at baseline)	40.0 percentage of total body mass Standard Deviation 7.6	37.7 percentage of total body mass Standard Deviation 11.2
Fat Mass (% of Total Body Mass) Post (i.e., after 2 months of treatment)	38.7 percentage of total body mass Standard Deviation 7.3	38.6 percentage of total body mass Standard Deviation 10.4

SECONDARY outcome

Timeframe: At baseline ("Pre") and after 2 months ("Post") of treatment or control

Population: Data from 1 participant in the Active CPAP group were missing from analyses due to technical problem.

Participants will be served meals (breakfast, lunch, dinner, snack) at specified times, but food will be served in excess such that participants will be able to eat as much as they want.

Outcome measures

Measure	Intervention - CPAP Use n=11 Participants Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months	Control - No CPAP Use n=12 Participants Control will be no use of CPAP for 2 months
ad Libitum Food Intake (Total Daily Calories Consumed) Pre (at baseline)	2999.9 kcal Standard Deviation 967.8	4631.0 kcal Standard Deviation 1854.5
ad Libitum Food Intake (Total Daily Calories Consumed) Post (after 2 months)	3301.6 kcal Standard Deviation 773.1	4479.3 kcal Standard Deviation 1769.4

OTHER_PRE_SPECIFIED outcome

Timeframe: At baseline and after 2 months of treatment or control

Blood will be sampled once in the morning in the fasted state to assay levels of circulating hormones that regulate appetite and hunger, including leptin, ghrelin, adiponectin, and glucagon-like peptide-1, as well as inflammatory and cardiovascular risk markers

Outcome measures

Outcome data not reported

Adverse Events

Intervention - CPAP Use

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - No CPAP Use

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

Ari Shechter

Columbia University

Phone: 2123424487

Email: as4874@cumc.columbia.edu

Results disclosure agreements

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