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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251574
• Other study ID #: STUDY00001418
• Status: Completed
• Phase: N/A
• First received: September 25, 2014
• Last updated: April 3, 2018
• Start date: September 2014
• Est. completion date: June 2016

Study information

• Verified date: April 2018
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Low Calorie Diet
Weight management program designed around a low calorie diet.
• Very Low Calorie Diet
Weight management program designed around a very low calorie diet.
• Standard Care
Care provided that would normally be given to people meeting eligibility criteria for this study.

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Apnea Hypopnea Index (AHI)	The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.	Change from Baseline to Month 3
Secondary	Change in Apnea Hypopnea Index (AHI)	The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.	Change from Baseline to Month 9
Secondary	Change in metabolic syndrome (MetS) risk factors	Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose	Change from Baseline to Month 3 and Month 9
Secondary	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.	Change from Baseline to Month 3 and Month 9
Secondary	Change in Daytime Sleepiness	Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant.	Change from Baseline to Month 3 and Month 9