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

University of Kansas Medical Center37 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Low Calorie DietOTHER

Weight management program designed around a low calorie diet.

Very Low Calorie DietOTHER

Weight management program designed around a very low calorie diet.

Standard CareOTHER

Care provided that would normally be given to people meeting eligibility criteria for this study.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Kansas Medical Center

Kansas City, Kansas, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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