A Quasi-experimental Study Testing a Mindfulness Meditation Mobile App on Sleep and Neurophysiological Outcomes Using the Oura Ring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Diaries
研究概览
简要总结
This is a quasi-experimental study with pre-post assessment using a convenience sample of Calm and Oura employees. We will employ two weeks of baseline data collection and administer the intervention for four-weeks. Participants will be randomized to one of three groups (i.e., general meditations, sleep meditations, or Sleep Stories). Self-report assessments will be conducted during baseline periods and during week 1 and week 4 of the intervention. Sleep diaries and objective (i.e., Oura ring and Calm app) usage data will be collected on a continual basis during intervention.
The purpose of this study is to:
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Test the preliminary effects of using Calm (daytime vs nighttime) for four weeks on sleep outcomes (sleep quality, sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time) using self-report and objective measures.
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Self-report: Sleep diaries, pre-sleep arousal (Pre-Sleep Arousal Survey), fatigue (Fatigue Severity Scale), daytime sleepiness (Epworth Sleepiness Scale), insomnia (Insomnia Severity Index), sleep quality (Pittsburgh Sleep Quality Index)
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Objective: Oura ring (sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time, REM/light/deep sleep).
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Test the preliminary effects of using Calm (daytime vs nighttime) on neurophysiological outcomes [heart rate variability (HRV), heart rate, respiratory rate] as measured by the Oura ring during meditation and after four-weeks of mobile meditation practice.
详细描述
More than 30% of the US population reports sleep disturbances, and the Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic. Current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for insomnia, Relaxation Therapy) are lengthy and limited due to the need for specialized providers. Pharmaco-therapy may help, however they have inherent limitations (e.g., tolerance, side effects, interactions) to their use. Novel treatments that effectively and conveniently address sleep disturbances (i.e., help individuals self-manage sleep) need further investigation.
Commercially available mobile applications (apps) may help individuals self-manage health conditions conveniently at low cost and with little to no side effects. Specifically, mindfulness-based interventions (e.g., mindfulness meditation) targeting sleep and delivered via a mobile app may be an attractive, feasible and effective solution to improve sleep. Few, if any sleep interventions testing mobile meditation apps have assessed their effects on sleep and most studies only include self-report measures rather than objective measures of sleep (e.g., portable sleep trackers). Additionally, no studies have assessed the neurophysiological changes (heart rate variability, heart rate, respiratory rate) during or with prolonged use of a mindfulness meditation mobile app and whether these changes vary based on time of day. Thus, there is an unexplored opportunity to efficiently and effectively test the use of a mindfulness meditation mobile app on sleep and neurophysiological outcomes.
Findings from our previous study testing the effects of the mindfulness meditation mobile app called Calm on sleep outcomes (manuscript in review; PloS one), suggest that the Calm app improves self-reported sleep quality, and decreases daytime fatigue, daytime sleepiness, and cognitive/somatic pre-sleep arousal in sleep disturbed adults. However, we did not collect any objective data to confirm these findings and are unsure if these findings can be replicated in otherwise healthy adults. We also did not collect any neurophysiological outcomes during meditation practice.
Therefore, the purpose of this study is to:
- Test the preliminary effects of using Calm (daytime vs nighttime) for four weeks on sleep outcomes (sleep quality, sleep onset, sleep efficiency, number of nighttime awakenings, total sleep time) using self-report and objective measures.
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
- Double (Investigator, Outcomes Assessor)
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
- •Employee of Calm or Oura
- •>18 years of age
- •English speaking
- •Willing to download the Calm app to their smartphone
- •Willing to wear Oura ring
- •Willing to be randomized.
排除标准
- •Oura employees who do not own an Oura ring
结局指标
主要结局
Pittsburgh Sleep Diaries
时间窗: Daily for 6 weeks
Sleep diaries assessing sleep/wake time and sleep quality
Pre-Sleep Arousal Survey
时间窗: Change from baseline pre-sleep arousal at 4-weeks; 16-items (8-items measure cognitive arousal and 8-items measure somatic arousal); Scores range from 8-40 with higher scores indicating greater pre-sleep arousal
Cognitive and somatic pre-sleep arousal
Insomnia Severity Index
时间窗: Change from baseline symptoms of insomnia at 4-weeks; 7-items; Scores range from 0-28 with higher scores indicating greater symptoms of insomnia.
Symptoms of insomnia
Fatigue Severity Scale
时间窗: Change from baseline fatigue at 4-weeks; 9-items; Scores range from 1-7 with higher scores indicating higher levels of fatigue.
Daytime fatigue
Epworth Sleepiness Scale
时间窗: Change from baseline daytime sleepiness at 4-weeks; 8-items; Scores range from 0-24 with higher scores indicating higher levels of daytime sleepiness.
Daytime sleepiness
次要结局
- Heart rate(Daily for 6 weeks)
- Sleep onset(Daily for 6 weeks)
- number of nightime awakenings(Daily for 6 weeks)
- Total sleep time(Daily for 6 weeks)
- Heart rate variability(Daily for 6 weeks)
- Sleep stages(Daily for 6 weeks)
- Respiratory rate(Daily for 6 weeks)
- Sleep efficiency(Daily for 6 weeks)
研究者
Jennifer Huberty
Associate Professor
Arizona State University