Effect of Whole Food Plant-based Diet in Patients with Obstructive Sleep Apnea
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obstructive Sleep Apnea
- Sponsor
- Mayo Clinic
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in Apnea-Hypopnea Index (AHI)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.
Investigators
Joseph Y. Cheung
Principal Investigator
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- •Daytime sleepiness with ESS score ≥
- •Patient's prior sleep study with AHI between ≥ 10 and ≤ 45 (4% scoring criterion).
- •On treatment for OSA, failed or not willing to use all other OSA treatment options
- •Has access to a weight scale at home or able to come into the Sleep Clinic to be weighed after the 8-week plant-based diet period.
Exclusion Criteria
- •Pregnancy or lactation.
- •Current use of a vegan diet.
- •Complex, central sleep apnea.
- •Pre-existing significant degree of cardio-pulmonary disease-heart failure with reduced EF of 35 or lower, unstable arrythmia, severe degree of pulmonary hypertension, severe degree of obstructive or restrictive lung disease including COPD and Interstitial lung disease.
- •On weight loss medications or starting new exercise regimen during the 8-week plant-based diet period.
Outcomes
Primary Outcomes
Change in Apnea-Hypopnea Index (AHI)
Time Frame: Baseline, 8 weeks
Measured using the WatchPat One for at Home Sleep Apnea Test (HSAT), the Apnea-Hypopnea Index (AHI) assess severity of sleep apnea by counting apnea events during sleep. Normal range is less than 5 events per hour and severe is considered more than 30 events per hour.
Change in daytime sleepiness
Time Frame: Baseline, 8 weeks
Measured using The Epworth sleepiness scale (ESS) which is an 8-item questionnaire that measures daytime sleepiness in participants. Possible scores range from 0-24, with higher scores indicating a higher average sleep propensity in daily life, and a worse outcome.
Secondary Outcomes
- Change in weight(Baseline, 8 weeks)