Daytime Sleepiness, Obstructive Sleep Apnea
Conditions
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.
Interventions
BEHAVIORALWhole Food Plant-Based Diet
A whole food, plant-based diet focuses on whole foods that are not processed. The diet places an emphasis on plant foods that are naturally lower in fat and includes eating a variety of plant foods (fruits, vegetables, beans and legumes, whole grains, nuts and seeds, spices and herbs).
Sponsors
Mayo Clinic
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Daytime sleepiness with ESS score ≥ 5. * 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. * BMI ≤ 22. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime sleepiness | 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. |
| Change in Apnea-Hypopnea Index (AHI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in weight | Baseline, 8 weeks | Measured in kilograms (kg) |
Countries
United States
Contacts
STUDY_DIRECTORJoseph Cheung, MD
Mayo Clinic
Outcome results
None listed