Back to resultsEffect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Primary Purpose
Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Calorie Diet
Very Low Calorie Diet
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- University of Kansas Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Low Calorie Diet
Very Low Calorie Diet
Standard Care
Arm Description
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
Participants will receive normal care.
Outcomes
Primary Outcome Measures
Change in Apnea Hypopnea Index (AHI)
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
Secondary Outcome Measures
Change in Apnea Hypopnea Index (AHI)
The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.
Change in metabolic syndrome (MetS) risk factors
Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose
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 in Daytime Sleepiness
Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant.
Full Information
NCT ID
NCT02251574
First Posted
September 25, 2014
Last Updated
April 3, 2018
Sponsor
University of Kansas Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02251574
Brief Title
Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Official Title
Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Calorie Diet
Arm Type
Experimental
Arm Description
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 1200-1500 calories per day.
Arm Title
Very Low Calorie Diet
Arm Type
Experimental
Arm Description
Participants will take part in an experimental weight management program involving a low calorie diet (LCD), about 520-800 calories per day.
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Participants will receive normal care.
Intervention Type
Other
Intervention Name(s)
Low Calorie Diet
Intervention Description
Weight management program designed around a low calorie diet.
Intervention Type
Other
Intervention Name(s)
Very Low Calorie Diet
Intervention Description
Weight management program designed around a very low calorie diet.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Care provided that would normally be given to people meeting eligibility criteria for this study.
Primary Outcome Measure Information:
Title
Change in Apnea Hypopnea Index (AHI)
Description
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 Outcome Measure Information:
Title
Change in Apnea Hypopnea Index (AHI)
Description
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
Title
Change in metabolic syndrome (MetS) risk factors
Description
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
Title
Change in Quality of Life
Description
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
Title
Change in Daytime Sleepiness
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeannine Goetz, PhD
Organizational Affiliation
University of Kansas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effect of a Very Low Calorie and Low Calorie Diet on Moderate to Severe Obstructive Sleep Apnea in Obese Adults
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