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Effects of CPAP on Energy Expenditure and Energy Intake in Obstructive Sleep Apnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by St. Luke's-Roosevelt Hospital Center
Sponsor:
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01944020
First received: September 12, 2013
Last updated: October 27, 2014
Last verified: October 2014
  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 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, energy metabolism, 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 sleeping metabolic rate and circulating leptin levels, and reductions in hunger and food intake. 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 Energy Expenditure and Energy Intake in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Energy expenditure [ Time Frame: After 2 months of treatment in both experimental phases ] [ Designated as safety issue: No ]
    Participants will remain in the whole-room indirect calorimetry chamber (metabolic chamber) for 23 hours during which time their total energy expenditure, as well as sleeping metabolic rate, and resting metabolic rate, will be measured.


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 [ 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


Estimated Enrollment: 25
Study Start Date: January 2014
Estimated Primary Completion Date: October 2016 (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 energy expenditure (EE) and energy intake (EI) in 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 2-d in-lab testing period at the Clinical Research Resource (CRR) at St. Luke's-Roosevelt Hospital. 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 CRR at St. Luke's-Roosevelt Hospital for a 2-d period. Patients will arrive at ~0800 h and will remain in the laboratory for the following 48 h. During the first 24 h, patients will remain in the whole-room indirect calorimetry chamber (metabolic chamber). During this time in the metabolic chamber, EE will be continuously monitored (total 24-h EE), including throughout the sleep episode (SMR), upon awakening in the fasted state (RMR), and after standard meals (postprandial EE). 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).

During the laboratory day 1, standardized meals for a weight maintenance diet will be served at fixed time-points, including breakfast (0900 h), lunch (1300 h), snack (1600 h), and dinner (1900 h). Ad libitum EI will be measured during laboratory day 2 for each treatment phase. Breakfast, lunch, snack, and dinner will still 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 on laboratory day 2.

  Eligibility

Ages Eligible for Study:   18 Years to 60 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 30 kg/m^2

Exclusion Criteria:

  • prior treatment with CPAP
  • cannot be shift workers
  • type 2 diabetes
  • poorly controlled severe hypertension
  • anemia
  • 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. 212-523-1616 ashechter@chpnet.org

Locations
United States, New York
St. Luke's-Roosevelt Hospital Recruiting
New York, New York, United States, 10025
Contact: Ari Shechter, Ph.D.    212-523-1616    ashechter@chpnet.org   
Principal Investigator: Ari Shechter, Ph.D.         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Ari Shechter, Ph.D. New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital
  More Information

No publications provided

Responsible Party: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01944020     History of Changes
Other Study ID Numbers: SLRH13-0119, DK26687-13-0119
Study First Received: September 12, 2013
Last Updated: October 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Sleep Apnea, Obstructive
Energy Balance
Food Intake
Energy Expenditure
Sleep
Obesity

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

ClinicalTrials.gov processed this record on November 27, 2014