Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: Standard Care; Other: Low Calorie Diet; Other: Very Low Calorie Diet

• Registration Number: NCT02251574
• Lead Sponsor: University of Kansas Medical Center

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-25
• Study First Submitted QC: 2014-09-25
• Study First Posted: 2014-09-29
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-03
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Participants will receive normal care.
Low Calorie Diet	Low Calorie Diet	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	Very 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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 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 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.

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States