RECRUITING

Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

Conditions

Obstructive Sleep Apnea Daytime Sleepiness

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effect of Whole Food Plant-based Diet in Patients With Obstructive Sleep Apnea

Quick Facts

Study Start:2024-05-14

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06395181

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Principal Investigator

Joseph Cheung, MD

STUDY_DIRECTOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Florida

Jacksonville, Florida, 32224

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Joseph Cheung, MD, STUDY_DIRECTOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14

Study Completion Date2026-05

Study Record Updates

Study Start Date2024-05-14

Study Completion Date2026-05

Terms related to this study

Additional Relevant MeSH Terms

Obstructive Sleep Apnea
Daytime Sleepiness