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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by Columbia University
Sponsor:
Information provided by (Responsible Party):
Ari Shechter, Columbia University
ClinicalTrials.gov Identifier:
NCT01944020
First received: September 12, 2013
Last updated: May 28, 2015
Last verified: May 2015
  Purpose

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.


Condition Intervention
Sleep Apnea Syndromes
Device: Active CPAP
Device: Sham CPAP

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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


Estimated Enrollment: 25
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)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 CAD, TIA, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01944020

Contacts
Contact: Ari Shechter, Ph.D. (212) 851-5575 as4874@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Ari Shechter, Ph.D.    212-851-5575    as4874@columbia.edu   
Principal Investigator: Ari Shechter, Ph.D.         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Ari Shechter, Ph.D. New York Obesity Research Center, Columbia University
  More Information

No publications provided

Responsible Party: Ari Shechter, Assistant Professor of Medical Sciences, Columbia University
ClinicalTrials.gov Identifier: NCT01944020     History of Changes
Other Study ID Numbers: AAAO2006, 15SDG22680012
Study First Received: September 12, 2013
Last Updated: May 28, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Sleep Apnea, Obstructive
Energy Balance
Food Intake
Energy Expenditure
Sleep
Obesity

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Apnea
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on August 03, 2015