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The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
Sleep apnea is a sleep disorder in which breathing repeatedly stops and starts during sleep. The most common type is obstructive sleep apnea (OSA), which occurs when the muscles in your throat relax and block your airway during sleep. The most noticeable sign of OSA is snoring. OSA is a risk factor for other chronic conditions like type 2 diabetes, cardiovascular disease, and high blood pressure.
Although anyone can develop OSA, it commonly affects people who are obese. The more someone weighs, the more likely the OSA is to be severe. Weight loss is typically recommended for overweight individuals to help improve OSA. However, not enough research has been done for doctors to be able make specific recommendations to their patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Calorie Diet | Experimental | Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day. |
|
| Very Low Calorie Diet | Experimental | Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day. |
|
| Standard Care | Active Comparator | Participants will receive normal care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Calorie Diet | Other | Weight management program designed around a low calorie diet. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea Hypopnea Index (AHI) | The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour. | Change from Baseline to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Apnea Hypopnea Index (AHI) | The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour. | Change from Baseline to Month 9 |
| Change in metabolic syndrome (MetS) risk factors |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeannine Goetz, PhD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | United States |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D031204 | Caloric Restriction |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D004035 | Diet Therapy |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
| D002149 | Energy Intake |
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| Very Low Calorie Diet |
| Other |
Weight management program designed around a very low calorie diet. |
|
| Standard Care | Other | Care provided that would normally be given to people meeting eligibility criteria for this study. |
|
Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
| Change from Baseline to Month 3 and Month 9 |
| Change in Quality of Life | Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment. | Change from Baseline to Month 3 and Month 9 |
| Change in Daytime Sleepiness | Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant. | Change from Baseline to Month 3 and Month 9 |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D004032 |
| Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |