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