Obstructive Sleep ApneaNCT06395181
Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea
A study testing Whole Food Plant-Based Diet in people with Obstructive Sleep Apnea and Daytime Sleepiness, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea, Daytime Sleepiness
- What is being tested?
- Whole Food Plant-Based Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Food Plant-based Diet in Patients With Obstructive Sleep Apnea
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
- Being tested
- Whole Food Plant-Based Diet
- Medical subject headings
- Sleep Apnea, Obstructive, Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Food Plant-Based DietBehavioural
Also called WFPB 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).
| Study group | Role | What they receive |
|---|---|---|
| Diet Group: Whole Food Plant Based Diet | Experimental | Subjects with follow a whole food plant-based diet for 8 weeks. Receives: Behavioral: Whole Food Plant-Based Diet |
| Control Group: Usual Care | No intervention | Subjects will not change their diet for 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 8 weeks
Secondary outcomes (1)
Change in weight
Measured in kilograms (kg)
Measured: Baseline, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start14 May 2024
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Why it stopped: Lack of funding to continue.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Y. Cheung, Mayo Clinic
- Investigators
- Joseph Cheung, MD, Study director, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06395181
- Sponsor's protocol ID
- 23-011675
- Status last verified
- Jul 2026
- First submitted
- 29 Apr 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Food Plant-based Diet in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06395181
- Acronym / sponsor ID
- 23-011675
- Conditions
- Obstructive Sleep Apnea, Daytime Sleepiness
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding to continue.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 14 May 2024 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet Group: Whole Food Plant Based Diet | Experimental | Behavioral: Whole Food Plant-Based DietSubjects with follow a whole food plant-based diet for 8 weeks. |
| Control Group: Usual Care | No intervention | –Subjects will not change their diet for 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole Food Plant-Based DietAlso: WFPB DietA 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). | Behavioural | Diet Group: Whole Food Plant Based Diet |
Primary outcome
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.
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.
1 secondary outcome
Change in weight
Time frame: Baseline, 8 weeks
Results and safety
The study was stopped early (reason given: Lack of funding to continue.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Cheung, MD study director
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Food Plant-Based Diet in people with Obstructive Sleep Apnea and Daytime Sleepiness, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding to continue.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in daytime sleepiness (time frame: Baseline, 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.