Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk
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 is for a randomized, placebo-controlled, crossover trial investigating the effects of 2 months of active and sham CPAP on energy balance and cardiovascular risk in obese patients with moderate-to-severe OSA and EDS. Patients will be instructed to use active or sham CPAP at home each night throughout the 2-month treatment phases. At the conclusion of each 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. It is hypothesized that active compared to sham CPAP 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk|
- Physical activity [ Time Frame: After 2 months of treatment in both experimental phases ] [ Designated as safety issue: No ]Free-living physical activity will be measured via actigraphy at baseline preceding both treatment phases, and at the end of each treatment phase.
- Ad libitum food intake [ Time Frame: After 2 months of treatment in both experimental phases ] [ Designated as safety issue: No ]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.
- Appetite-regulating hormones and cardiovascular risk factors [ Time Frame: After 2 months of treatment in both experimental phases ] [ Designated as safety issue: No ]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
|Study Start Date:||May 2015|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||March 2018 (Final data collection date for primary outcome measure)|
Active Comparator: Active CPAP
Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months
Device: Active CPAP
Active CPAP will be a therapeutic dose CPAP each night for 2 months
Sham Comparator: Sham CPAP
Sham CPAP will be a sub-therapeutic dose of positive airway pressure each night for 2 months
Device: Sham CPAP
Other Name: Sham CPAP will be a sub-therapeutic dose of CPAP each night for 2 months
This study will be a randomized, placebo-controlled, crossover trial investigating the effects of 2 mo of active and sham continuous positive airway pressure (CPAP) on physical activity, energy intake (EI), and cardiovascular risk factors in overweight/obese patients with moderate-to-severe obstructive sleep apnea (OSA) and excessive daytime sleepiness (EDS). Following pre-experimental baseline measures, patients (blinded to condition) will be instructed to use active or sham CPAP at home each night throughout the 2 mo treatment phases. After each 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 1 mo washout period, followed by the second 2 mo treatment phase, including laboratory visit 2.
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 al,so 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01944020
|Contact: Ari Shechter, Ph.D.||(212) email@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Ari Shechter, Ph.D. 212-851-5575 firstname.lastname@example.org|
|Principal Investigator: Ari Shechter, Ph.D.|
|Principal Investigator:||Ari Shechter, Ph.D.||New York Obesity Research Center, Columbia University|