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

Primary Purpose

Sleep Apnea Syndromes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Sleep Apnea, Obstructive, Energy Balance, Food Intake, Energy Expenditure, Sleep, Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention - CPAP use

Control - No CPAP use

Arm Description

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

Control will be no use of CPAP for 2 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

ad Libitum Food Intake (Total Daily Calories Consumed)
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.

Full Information

First Posted
September 12, 2013
Last Updated
April 8, 2022
Sponsor
Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT01944020
Brief Title
Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk
Official Title
Effects of CPAP on Diet, Physical Activity, and Cardiovascular Risk
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study investigates the effects of 2 mo of continuous positive airway pressure (CPAP) on physical activity, energy intake (EI), and cardiovascular risk factors in overweight/obese patients with obstructive sleep apnea (OSA). Patients will be instructed to use CPAP at home each night throughout the 2 mo treatment phase. Before and after the 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 2 mo treatment period, followed by the second tracking period including laboratory visit 2. Before and 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 also 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. There will also be a control group of individuals with OSA who do not use CPAP who are studied at baseline and again after a 2 month period in procedures similar to those undergoing treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
Sleep Apnea, Obstructive, Energy Balance, Food Intake, Energy Expenditure, Sleep, Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
treatment group: individuals with OSA using CPAP control group: individuals with OSA not using CPAP
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention - CPAP use
Arm Type
Experimental
Arm Description
Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months
Arm Title
Control - No CPAP use
Arm Type
No Intervention
Arm Description
Control will be no use of CPAP for 2 months
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
use of CPAP each night for 2 months
Primary Outcome Measure Information:
Title
Fat Mass (% of Total Body Mass)
Description
Fat mass (% of total body mass) measured via BODPOD at baseline preceding treatment phase, and at the end of treatment phase.
Time Frame
At baseline ("Pre") and after 2 months of treatment ("Post") or control
Secondary Outcome Measure Information:
Title
ad Libitum Food Intake (Total Daily Calories Consumed)
Description
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.
Time Frame
At baseline ("Pre") and after 2 months ("Post") of treatment or control
Other Pre-specified Outcome Measures:
Title
Appetite-regulating Hormones and Cardiovascular Risk Factors at 2 Months
Description
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
Time Frame
At baseline and after 2 months of treatment or control

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ari Shechter, Ph.D.
Organizational Affiliation
New York Obesity Research Center, Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27769851
Citation
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.
Results Reference
derived
PubMed Identifier
26371702
Citation
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.
Results Reference
derived

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

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