Health TrialsbyHealthPanel

Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

ConditionsObstructive Sleep ApneaDaytime Sleepiness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Pregnancy or lactation.

Current use of a vegan diet.

BMI ≤ 22.

Complex, central sleep apnea.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Diet Group: Whole Food Plant Based DietExperimental treatment 1 intervention
Group B: Control Group: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 8 weeks
2

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.

Time frame
Baseline, 8 weeks

Secondary outcomes

1

Change in weight

Measured in kilograms (kg)

Time frame
Baseline, 8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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