Overview

This trial is active, not recruiting.

Condition obstructive sleep apnea
Treatments low calorie diet, very low calorie diet, standard care
Sponsor Jeannine Goetz, PhD
Start date September 2014
End date June 2016
Trial size 40 participants
Trial identifier NCT02251574, STUDY00001418

Summary

The purpose of this study is to test the effectiveness of two different weight loss diets on obstructive sleep apnea (OSA) severity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
low calorie diet
Weight management program designed around a low calorie diet.
(Experimental)
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
very low calorie diet
Weight management program designed around a very low calorie diet.
(Active Comparator)
Participants will receive normal care.
standard care
Care provided that would normally be given to people meeting eligibility criteria for this study.

Primary Outcomes

Measure
Change in Apnea Hypopnea Index (AHI)
time frame: Change from Baseline to Month 3

Secondary Outcomes

Measure
Change in Apnea Hypopnea Index (AHI)
time frame: Change from Baseline to Month 9
Change in metabolic syndrome (MetS) risk factors
time frame: Change from Baseline to Month 3 and Month 9
Change in Quality of Life
time frame: Change from Baseline to Month 3 and Month 9
Change in Daytime Sleepiness
time frame: Change from Baseline to Month 3 and Month 9

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

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

Additional Information

Official title Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Principal investigator Jeannine Goetz, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Kansas Medical Center.