Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

NCT06395181 | Recruiting

• 1 other identifier: 23-011675
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Daytime Sleepiness

Outcome Measures

Primary Outcomes (2)

• Change in daytime sleepiness

  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.

  Baseline, 8 weeks

• Change in Apnea-Hypopnea Index (AHI)

  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.

  Baseline, 8 weeks

Secondary Outcomes (1)

• Change in weight

  Baseline, 8 weeks

Study Arms (2)

Diet Group: Whole Food Plant Based Diet

EXPERIMENTAL

Subjects with follow a whole food plant-based diet for 8 weeks.

Behavioral: Whole Food Plant-Based Diet

Control Group: Usual Care

NO INTERVENTION

Subjects will not change their diet for 8 weeks.

Interventions

Whole Food Plant-Based Diet BEHAVIORAL

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).

Also known as: WFPB Diet

Diet Group: Whole Food Plant Based Diet

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Joseph Cheung, MD

  Mayo Clinic

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 29, 2024
• First Posted: May 2, 2024
• Study Start: May 14, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)