N/A
N=29
Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk
Sleep Apnea Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT01944020 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2022
Primary outcome: Primary: Fat Mass (% of Total Body Mass) — 40.0; 37.7; 38.7; 38.6 percentage of total body mass
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CPAP (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fat Mass (% of Total Body Mass) |
40.0; 37.7; 38.7; 38.6 | — |
| SECONDARY ad Libitum Food Intake (Total Daily Calories Consumed) |
2999.9; 4631.0; 3301.6; 4479.3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01944020). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.