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Behavioral Intervention
Plant-Based Diet for Sleep Apnea
N/A
Recruiting
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Complex, central sleep apnea
Pre-existing significant degree of cardio-pulmonary disease-congestive heart failure, active arrythmia, cardiomyopathy, pulmonary hypertension, severe degree of obstructive or restrictive lung disease including COPD and Interstitial lung disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 8 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to study how a plant-based diet affects the severity and daytime sleepiness in people with Obstructive Sleep Apnea.
Who is the study for?
This trial is for individuals who experience excessive daytime sleepiness and have been diagnosed with Obstructive Sleep Apnea. The specific eligibility criteria to participate in the study are not provided, but typically participants would need to meet certain health conditions.
What is being tested?
The study is examining how a Whole Food Plant-Based Diet affects people with Obstructive Sleep Apnea, specifically looking at its impact on the severity of their condition and their levels of daytime sleepiness.
What are the potential side effects?
While not explicitly mentioned, potential side effects from switching to a Whole Food Plant-Based Diet may include initial digestive changes such as bloating or gas, nutrient deficiencies if not properly planned, and possible withdrawal symptoms from reducing processed foods.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with a complex form of central sleep apnea.
Select...
I have a serious heart or lung condition, such as heart failure or severe COPD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 8 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Apnea-Hypopnea Index (AHI)
Change in daytime sleepiness
Secondary study objectives
Change in weight
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Diet Group: Whole Food Plant Based DietExperimental Treatment1 Intervention
Subjects with follow a whole food plant-based diet for 8 weeks.
Group II: Control Group: Usual CareActive Control1 Intervention
Subjects will not change their diet for 8 weeks.
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,360 Previous Clinical Trials
3,065,901 Total Patients Enrolled
Joseph Cheung, MDStudy DirectorMayo Clinic
1 Previous Clinical Trials
12 Total Patients Enrolled