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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01944020
Enrollment
29
Registered
2013-09-17
Start date
2015-05-31
Completion date
2018-09-30
Last updated
2022-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea, Obstructive, Energy Balance, Food Intake, Energy Expenditure, Sleep, Obesity

Brief summary

Obstructive sleep apnea (OSA) is characterized by recurrent episodes of partial or complete loss of airflow during sleep, due to narrowing or closure of the upper airway. The resulting hypoxia has many cardiometabolic consequences, and leads to a disruption of sleep quality including reductions in the expression of rapid eye movement (REM) sleep and slow wave sleep (SWS). Patients also frequently experience excessive daytime sleepiness (EDS), which, when present with OSA, defines the clinical entity OSA syndrome (OSAS). Obesity is the leading risk factor for the development of OSA. Interestingly, it has been suggested that the disorder itself may contribute to further weight gain, presenting a vicious cycle wherein OSA and obesity perpetuate each other. OSAS may promote weight gain by placing patients in a state of positive energy balance characterized by low levels of physical activity and disrupted patterns of appetite-regulating hormones. Continuous positive airway pressure (CPAP), the gold-standard treatment of OSAS, may improve energy balance in these patients, although this has not yet been adequately studied. The current proposal will investigate the effects of 2 months of CPAP on energy balance and cardiovascular risk in obese patients with OSA. Patients will be instructed to use CPAP at home each night throughout the 2-month treatment phases. At baseline and at the conclusion of the 2-month treatment phase, the investigators will measure levels of free-living physical activity, sleepiness, sleep quality, body composition, cardiovascular risk factors, appetite-regulating hormones, hunger, and ad libitum food intake. There will also be a control group with OSA individuals studied at baseline and again after 2 months with no CPAP use. It is hypothesized that CPAP compared to no treatment treatment will result in improvements in energy balance, including increased physical activity, reductions in abnormally high levels of circulating leptin levels, and reductions in hunger, food intake, and cardiovascular risk factors. These improvements are hypothesized to be associated with increases in the expression of REM sleep and SWS, and reduced EDS as a result of CPAP.

Detailed description

This study investigates the effects of 2 mo of continuous positive airway pressure (CPAP) on physical activity, energy intake (EI), and cardiovascular risk factors in overweight/obese patients with obstructive sleep apnea (OSA). Patients will be instructed to use CPAP at home each night throughout the 2 mo treatment phase. Before and after the 2 mo treatment phase, patients will undergo a 1-d in-lab testing period at the Clinical Research Resource (CRR) at Columbia University Medical Center. Upon completion of the laboratory phase 1, patients will return home for a 2 mo treatment period, followed by the second tracking period including laboratory visit 2. Before and at the conclusion of the 2 mo treatment phase, patients will enter the laboratory at the Columbia University Medical Center for a 1-d period. Patients will arrive at \ 0800 h and will remain in the laboratory for the following 24 h. Blood will be sampled in the fasting state in the morning, and will be assayed for select appetite-regulating hormones (leptin, ghrelin, adiponectin, glucagon-like peptide-1). We will also assess body composition. During the laboratory day, ad libitum EI will be measured for each treatment phase. Breakfast, lunch, snack, and dinner will be served at the standard times, but each meal item will be served in excess such that patients will be able to eat as much or as little of each food as they choose. Additional snack choices will also be freely available during the wake episode. There will also be a control group of individuals with OSA who do not use CPAP who are studied at baseline and again after a 2 month period in procedures similar to those undergoing treatment.

Interventions

DEVICECPAP

use of CPAP each night for 2 months

Sponsors

Columbia University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

treatment group: individuals with OSA using CPAP control group: individuals with OSA not using CPAP

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* clinical diagnosis of obstructive sleep apnea (OSA) and excessive daytime sleepiness (EDS) * body mass index of at least 25 kg/m\^2

Exclusion criteria

* prior treatment with CPAP * shift workers * type 2 diabetes * poorly controlled severe hypertension * anemia * history of coronary artery disease, transient ischemic attack, stroke * currently taking anti-psychotic, anti-depressive, or hypnotic medications * females currently taking hormone replacement therapy * females who are pregnant or have given birth within 1 year

Design outcomes

Primary

MeasureTime frameDescription
Fat Mass (% of Total Body Mass)At baseline (Pre) and after 2 months of treatment (Post) or controlFat mass (% of total body mass) measured via BODPOD at baseline preceding treatment phase, and at the end of treatment phase.

Secondary

MeasureTime frameDescription
ad Libitum Food Intake (Total Daily Calories Consumed)At baseline (Pre) and after 2 months (Post) of treatment or controlParticipants 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.

Other

MeasureTime frameDescription
Appetite-regulating Hormones and Cardiovascular Risk Factors at 2 MonthsAt baseline and after 2 months of treatment or controlBlood 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

Countries

United States

Participant flow

Participants by arm

ArmCount
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
12
Control - No CPAP Use
Control will be no use of CPAP for 2 months
12
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyWithdrawal by Subject50

Baseline characteristics

CharacteristicIntervention - CPAP UseControl - No CPAP UseTotal
Age, Continuous47.7 years
STANDARD_DEVIATION 10.9
53.1 years
STANDARD_DEVIATION 11.6
50.4 years
STANDARD_DEVIATION 11.3
Body mass index35.6 kg/m^2
STANDARD_DEVIATION 4
34.9 kg/m^2
STANDARD_DEVIATION 6.5
35.2 kg/m^2
STANDARD_DEVIATION 5.2
Race/Ethnicity, Customized
Asian Non-Hispanic
1 Participants1 Participants2 Participants
Race/Ethnicity, Customized
Black Non-Hispanic
4 Participants8 Participants12 Participants
Race/Ethnicity, Customized
Hispanic
2 Participants3 Participants5 Participants
Race/Ethnicity, Customized
White Non-Hispanic
5 Participants0 Participants5 Participants
Region of Enrollment
United States
12 participants12 participants24 participants
Sex: Female, Male
Female
5 Participants5 Participants10 Participants
Sex: Female, Male
Male
7 Participants7 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

Primary

Fat Mass (% of Total Body Mass)

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

Time frame: At baseline (Pre) and after 2 months of treatment (Post) or control

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

ArmMeasureGroupValue (MEAN)Dispersion
Intervention - CPAP UseFat Mass (% of Total Body Mass)Pre (i.e., at baseline)40.0 percentage of total body massStandard Deviation 7.6
Intervention - CPAP UseFat Mass (% of Total Body Mass)Post (i.e., after 2 months of treatment)38.7 percentage of total body massStandard Deviation 7.3
Control - No CPAP UseFat Mass (% of Total Body Mass)Pre (i.e., at baseline)37.7 percentage of total body massStandard Deviation 11.2
Control - No CPAP UseFat Mass (% of Total Body Mass)Post (i.e., after 2 months of treatment)38.6 percentage of total body massStandard Deviation 10.4
Secondary

ad Libitum Food Intake (Total Daily Calories Consumed)

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.

Time frame: 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.

ArmMeasureGroupValue (MEAN)Dispersion
Intervention - CPAP Usead Libitum Food Intake (Total Daily Calories Consumed)Pre (at baseline)2999.9 kcalStandard Deviation 967.8
Intervention - CPAP Usead Libitum Food Intake (Total Daily Calories Consumed)Post (after 2 months)3301.6 kcalStandard Deviation 773.1
Control - No CPAP Usead Libitum Food Intake (Total Daily Calories Consumed)Pre (at baseline)4631.0 kcalStandard Deviation 1854.5
Control - No CPAP Usead Libitum Food Intake (Total Daily Calories Consumed)Post (after 2 months)4479.3 kcalStandard Deviation 1769.4
Other Pre-specified

Appetite-regulating Hormones and Cardiovascular Risk Factors at 2 Months

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

Time frame: At baseline and after 2 months of treatment or control

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026