Remote Assessment of Digital Neurologic Testing (RADiaNT)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Duration in slow wave sleep
研究概览
简要总结
The RADiaNT study investigates whether guided meditation, using the Muse™ headband and biofeedback app, can improve sleep, mood, and cognitive performance, aiming to assess its impact on mental and emotional well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Cognition unimpaired or mild cognitive impairment
- •Fluent in English
- •United States resident
- •Able to tolerate wearing Muse headband
- •basic competence in using electronic devices (Smartphone or tablet) to engage with the Muse application and complete digital surveys and assessments
排除标准
- •Neurological and Brain Disorders
- •Not Fluent in English
- •Not a US Resident
- •Unable to tolerate wearing Muse Headband
研究组 & 干预措施
Guided Meditation
This cohort will be practicing guided meditation for 5 days/week, five minutes a day for 6 weeks. Then there will be a period of testing followed by another 6 week period of practicing guided meditation.
干预措施: Guided Meditation (Behavioral)
Standard of Care
This cohort will be asked to complete neurologic testing at baseline, interim, and conclusion periods while conducting NO guided meditation throughout the duration of the study.
结局指标
主要结局
Duration in slow wave sleep
时间窗: 17 weeks
Total duration of sleep time spent in slow wave sleep (delta), reported in minutes
Proportion in slow wave sleep
时间窗: 17 weeks
Proportion is the percentage of sleep time spent in slow wave sleep (delta)
Perceived Stress Scale
时间窗: 17 weeks
Investigators will ask patients to answer the PSS questionnaire at the beginning, interim, and end of the study to see if there were any improvements in sleep quality over the intervention periods. This questionnaire is on a scale that scores 0-40, with the higher the score being a higher level of stress.
次要结局
- Patient Health Questionnaire 9-item (PHQ-9)(17 weeks)
- General Anxiety Disorder 7-item (GAD-7)(17 weeks)
- Cognitive Performance(17 weeks)
研究者
David T. Jones
Principal Investigator
Mayo Clinic