Effects of a plant-based diet on obstructive sleep apnea
Effect of Whole Food Plant-based Diet in Patients With Obstructive Sleep Apnea
This study is testing whether following a whole food plant-based diet for eight weeks can help people with obstructive sleep apnea feel better and reduce daytime sleepiness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06395181 on ClinicalTrials.gov |
What this trial studies
This research investigates how a whole food plant-based diet influences the severity of obstructive sleep apnea and associated daytime sleepiness. Participants will follow this diet for eight weeks, and their sleep apnea severity will be assessed through prior sleep studies and daytime sleepiness evaluations. The study aims to provide clinical insights into dietary interventions for managing obstructive sleep apnea.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing daytime sleepiness with an Epworth Sleepiness Scale score of 5 or higher and diagnosed with obstructive sleep apnea.
Not a fit: Patients with complex or central sleep apnea, significant cardio-pulmonary diseases, or those currently on a vegan diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a non-pharmacological approach to improve symptoms of obstructive sleep apnea and enhance daytime alertness.
How similar studies have performed: While there is limited research specifically on plant-based diets for obstructive sleep apnea, dietary interventions have shown promise in improving sleep-related conditions in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Jacksonville, Florida
- Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.