Effect of Whole Food Plant-based Diet in Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in Apnea-Hypopnea Index (AHI)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Daytime sleepiness with ESS score ≥
- •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.
排除标准
- •Pregnancy or lactation.
- •Current use of a vegan diet.
- •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.
研究组 & 干预措施
Diet Group: Whole Food Plant Based Diet
Subjects with follow a whole food plant-based diet for 8 weeks.
干预措施: Whole Food Plant-Based Diet (Behavioral)
Control Group: Usual Care
Subjects will not change their diet for 8 weeks.
结局指标
主要结局
Change in Apnea-Hypopnea Index (AHI)
时间窗: 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.
Change in daytime sleepiness
时间窗: 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.
次要结局
- Change in weight(Baseline, 8 weeks)
研究者
Joseph Y. Cheung
Principal Investigator
Mayo Clinic