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

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Other: Low Calorie Diet; Other: Very Low Calorie Diet; Other: Standard Care

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 Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Low Calorie Diet; Weight management program designed around a low calorie diet.
Experimental: 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.	Other: Very Low Calorie Diet; Weight management program designed around a very low calorie diet.
Active Comparator: Standard Care; Participants will receive normal care.	Other: Standard Care; Care provided that would normally be given to people meeting eligibility criteria for this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Jeannine Goetz, PhD, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 25, 2014
• First Submitted That Met QC Criteria: September 25, 2014
• First Posted (Estimate): September 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2018
• Last Update Submitted That Met QC Criteria: April 3, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: STUDY00001418