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

NCT01944020 | Completed Results DMC

• 2 other identifiers: AAAO200615SDG22680012
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep Apnea Syndromes

Keywords

Sleep Apnea, Obstructive; Energy Balance; Food Intake; Energy Expenditure; Sleep; Obesity

Outcome Measures

Primary Outcomes (1)

• Fat Mass (% of Total Body Mass)

  Fat mass (% of total body mass) measured via BODPOD at baseline preceding treatment phase, and at the end of treatment phase.

  At baseline ("Pre") and after 2 months of treatment ("Post") or control

Secondary Outcomes (1)

• ad Libitum Food Intake (Total Daily Calories Consumed)

  At baseline ("Pre") and after 2 months ("Post") of treatment or control

Other Outcomes (1)

• Appetite-regulating Hormones and Cardiovascular Risk Factors at 2 Months

  At baseline and after 2 months of treatment or control

Study Arms (2)

Intervention - CPAP use

EXPERIMENTAL

Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months

Device: CPAP

Control - No CPAP use

NO INTERVENTION

Control will be no use of CPAP for 2 months

Interventions

CPAP DEVICE

use of CPAP each night for 2 months

Intervention - CPAP use

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of obstructive sleep apnea (OSA) and excessive daytime sleepiness (EDS)
• body mass index of at least 25 kg/m\^2

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Shechter A, Kovtun K, St-Onge MP. Effects of continuous positive airway pressure on energy intake in obstructive sleep apnea: A pilot sham-controlled study. Physiol Behav. 2016 Dec 1;167:399-403. doi: 10.1016/j.physbeh.2016.10.011. Epub 2016 Oct 18.

  PMID: 27769851 DERIVED

• Shechter A, Pham T, Rising R, St-Onge MP. Effects of CPAP on energy expenditure in obese obstructive sleep apnoea patients: A pilot study. Obes Res Clin Pract. 2015 Nov-Dec;9(6):618-21. doi: 10.1016/j.orcp.2015.08.015. Epub 2015 Sep 11.

  PMID: 26371702 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Obesity

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ari Shechter
• Organization: Columbia University

as4874@cumc.columbia.edu

2123424487

Study Officials

• Ari Shechter, Ph.D.

  New York Obesity Research Center, Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medical Sciences

Model Details: treatment group: individuals with OSA using CPAP control group: individuals with OSA not using CPAP

Study Record Dates

• First Submitted: September 12, 2013
• First Posted: September 17, 2013
• Study Start: May 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 3, 2022
• Results First Posted: May 3, 2022

Record last verified: 2022-04

Locations

US (1)