Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
Detailed description
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.
Interventions
OTHERLow Calorie Diet
Weight management program designed around a low calorie diet.
Weight management program designed around a very low calorie diet.
OTHERStandard Care
Care provided that would normally be given to people meeting eligibility criteria for this study.
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* AHI score of ≥ 5 * Body mass index (BMI) between 30 to 49.9 kg/m2
Exclusion criteria
* Report serious medical risk such as insulin-dependent diabetes, active cancer, recent cardiac event * Currently or planning to become pregnant during the next 9 months * Not weight stable (-4.6 kg) for 3 mos. prior to intake * Report current participation in a weight reduction program involving diet or PA * Unwilling to be randomized to 1 of 3 study groups * Report symptomology of an eating disorder as determined by the Eating Attitudes Test * Unable to participate in moderate intensity physical activity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea Hypopnea Index (AHI) | Change from Baseline to Month 3 | The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea Hypopnea Index (AHI) | Change from Baseline to Month 9 | The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour. |
| Change in metabolic syndrome (MetS) risk factors | Change from Baseline to Month 3 and Month 9 | Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose |
| Change in Quality of Life | Change from Baseline to Month 3 and Month 9 | Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment. |
| Change in Daytime Sleepiness | Change from Baseline to Month 3 and Month 9 | Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant. |
Countries
United States
Outcome results
None listed