Chorus Sleep Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Preliminary effects of the Chorus Sleep app on sleep related impairment, as assessed by changes in participants' self-reported sleep related impairment from pre- to post- 6-week intervention period
研究概览
简要总结
This pilot study will evaluate the feasibility of a 6-week intervention using Chorus Sleep's ios app to improve sleep quality, reduce stress, and reduce depression and anxiety using a randomized controlled design.
详细描述
Chorus Sleep is a successful wellness company with a loyal and growing clientele, and considerable qualitative and anecdotal evidence for its efficacy at reducing stress, and improving sleep quality. It builds upon existing meditation and mindfulness practices with well documented efficacy for reducing pain, improving mental health, and reducing stress. Further its innovative approach - including the use of popular music and breathwork patterns that elicit stimulating and novel sensations and physiological activity - may removes barriers to participation and engagement of many traditional meditation and mindfulness practices. Prior research evaluating the efficacy of audio meditation using the Calm app found use of the app for eight weeks significantly decreased daytime fatigue and sleepiness and pre-sleep arousal compared to a wait-list control group. Further, use of the calm app for 8 weeks was associated with greater improvements in depression and anxiety symptoms, and those effects were mediated by lower pre-sleep arousal. This study will investigate whether Chorus Sleep's innovation in auditory app-based sleep inventions will demonstrate similar efficacy.
This study has the following objectives:
- Pilot a randomized controlled trial on Chorus sleep to evaluate feasibility.
- Evaluate the effect of Chorus sleep practice at improving sleep quality.
- Evaluate the effect of Chorus sleep practice at reducing perceived stress, depression, and anxiety, both directly and indirectly through improved sleep quality.
- Characterize habit formation of Chorus sleep practice
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
盲法说明
This is a waitlist controlled design to a behavioral intervention. Assignment will not be masked.
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
- •Fluent English speakers
- •Have an Apple Iphone 8 or later
- •Have a bed to sleep in consistently every night
排除标准
- •Narcolepsy
- •night shift or shift work for more than 2 nights per week.
- •Used the Chorus sleep app more than one time prior to the beginning of the trial.
结局指标
主要结局
Preliminary effects of the Chorus Sleep app on sleep related impairment, as assessed by changes in participants' self-reported sleep related impairment from pre- to post- 6-week intervention period
时间窗: Within 24 hours pre-and within 1 week post- 6 week intervention
Change in total score on the PROMIS Sleep Related Impairment Scale from baseline to 6-week follow-up. Mean scores across the 8 items will be used. Items are a 5-point scale from 1-5. Therefore, the range of possible change scores is from -4 to 4, where a lower negative score corresponds with greater decreases in sleep disturbance, a higher score corresponds with greater increases in sleep disturbance, and 0 indicates no change.
次要结局
- Change in depression symptoms(Within 24 hours pre-and within 1 week post- 6 week intervention)
- Change in anxiety symptoms from baseline to 6-week follow-up.(Within 24 hours pre-and within 1 week post- 6 week intervention)
- Change in perceived stress(Within 24 hours pre-and within 1 week post- 6 week intervention)
- Demand, based on frequency of use of the Chorus Sleep app(Recorded continuously throughout 6-week intervention)