University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
NCT Number: NCT02251574
The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.
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Notify Me21 year–75 year
All sexes
Interventional
Not applicable
Kansas City, Kansas, 66160, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Weight management program designed around a low calorie diet.
Weight management program designed around a very low calorie diet.
Care provided that would normally be given to people meeting eligibility criteria for this study.
Time frame: Change from Baseline to Month 3
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
Time frame: Change from Baseline to Month 9
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
Time frame: Change from Baseline to Month 3 and Month 9
Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
Time frame: 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.
Time frame: 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.
University of Kansas Medical Center
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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