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OpenTrials
Completed

NCT Number: NCT02251574

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

low calorie diet

Other

Weight management program designed around a low calorie diet.

very low calorie diet

Other

Weight management program designed around a very low calorie diet.

Standard care

Other

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

Primary outcomes

  1. Change in Apnea Hypopnea Index (AHI)

    Time frame: Change from Baseline to Month 3

    The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.

Secondary outcomes

  1. Change in Apnea Hypopnea Index (AHI)

    Time frame: Change from Baseline to Month 9

    The AHI measures sleep apnea severity and represents the number of apnea and hypopnea events per hour.

  2. Change in metabolic syndrome (MetS) risk factors

    Time frame: Change from Baseline to Month 3 and Month 9

    Risk factors to be measured include waist circumference, triglycerides, HDL-cholesterol, blood pressure, fasting glucose

  3. Change in Quality of Life

    Time frame: Change from Baseline to Month 3 and Month 9

    Participants will complete the Calgary Sleep Apnea Quality of Life Index (SAQLI) that will assess participants response to the intervention/treatment.

  4. Change in Daytime Sleepiness

    Time frame: Change from Baseline to Month 3 and Month 9

    Researchers will administer Epworth Sleepiness Scale. Results will be used to calculate daytime sleepiness changes for each participant.

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 29, 2014
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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