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| ID | Type | Description | Link |
|---|---|---|---|
| 15SDG22680012 | Other Grant/Funding Number | American Heart Association |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention - CPAP use | Experimental | Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months |
|
| Control - No CPAP use | No Intervention | Control will be no use of CPAP for 2 months |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP | Device | use of CPAP each night for 2 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline ("Pre") and after 2 months ("Post") of treatment or control |
| Measure | Description | Time Frame |
|---|---|---|
| Appetite-regulating Hormones and Cardiovascular Risk Factors at 2 Months | 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 | At baseline and after 2 months of treatment or control |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ari Shechter, Ph.D. | New York Obesity Research Center, Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27769851 | Derived | 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. | |
| 26371702 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention - CPAP Use | Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months |
| FG001 | Control - No CPAP Use | Control will be no use of CPAP for 2 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed the intervention
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention - CPAP Use | Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months |
| BG001 | Control - No CPAP Use |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | all completed CPAP group and non-CPAP group participants | Posted | Mean | Standard Deviation | percentage of total body mass | At baseline ("Pre") and after 2 months of treatment ("Post") or control |
|
2 months
any side effect of adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention - CPAP Use | Active CPAP will be a therapeutic dose of positive airway pressure each night for 2 months CPAP: use of CPAP each night for 2 months |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ari Shechter | Columbia University | 2123424487 | as4874@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 29, 2017 | Aug 4, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 3, 2021 | Aug 4, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D020181 | Sleep Apnea, Obstructive |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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treatment group: individuals with OSA using CPAP control group: individuals with OSA not using CPAP
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Control will be no use of CPAP for 2 months
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
|
| Secondary | 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. | Data from 1 participant in the Active CPAP group were missing from analyses due to technical problem. | Posted | Mean | Standard Deviation | kcal | At baseline ("Pre") and after 2 months ("Post") of treatment or control |
|
|
|
| Other Pre-specified | Appetite-regulating Hormones and Cardiovascular Risk Factors at 2 Months | 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 | Not Posted | At baseline and after 2 months of treatment or control | Participants |
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Control - No CPAP Use | Control will be no use of CPAP for 2 months | 0 | 12 | 0 | 12 | 0 | 12 |
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |