An interventional study of Low Calorie Diet and Very Low Calorie Diet in Obstructive Sleep Apnea, sponsored by University of Kansas Medical Center. Completed at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-04-05.
Sponsored by University of Kansas Medical Center · Not applicable, Interventional, and Treatment
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.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 37 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →University of Kansas Medical Center is the lead sponsor of 483 studies on the registry; 113 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
Other: Low Calorie Diet
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
Other: Very Low Calorie Diet
Participants will receive normal care.
Other: Standard Care
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.
Change in Apnea Hypopnea Index (AHI)
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
Change in Apnea Hypopnea Index (AHI)
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
Change in metabolic syndrome (MetS) risk factors
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
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.
Time frame: 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.
Time frame: Change from Baseline to Month 3 and Month 9
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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University of Kansas Medical Center