背景:西方国家三分之一的成年人睡眠质量受损。一个可能的解决方案是通过智能手机应用程序分发睡眠辅助工具,但大多数实证研究仅限于不同人群的小型试点试验(例如,士兵)或患有临床睡眠障碍的个人;因此,需要一般人口数据。此外,最近的研究表明,睡眠应用程序用户渴望一种个性化的方法,提供个性化的技术选择。一个这样的帮助是峰值睡眠,基于科学验证的改善睡眠质量的原则的智能手机应用程序,比如正念冥想和认知行为疗法。
目的:我们旨在测试智能手机应用程序PeakSleep对睡眠质量的影响,并收集用户体验数据,以便于未来的应用程序开发。
方法:这是一项双臂先导随机对照试验。参与者是英国的普通成年人(年龄≥18岁),他们对改善睡眠质量感兴趣,并且没有接受睡眠障碍的临床治疗或每周使用睡眠药物≥1次。参与者分别随机接受干预(3个月的应用程序使用),而非无治疗对照。干预措施包括免费进入睡眠峰值,一个提供行为技巧选择的应用程序,以支持更好的睡眠(正念,认知行为疗法,和接受承诺疗法)。主要结果是在基线时使用失眠严重程度指数评估睡眠质量,2-,和3个月的随访。使用基于网络的问卷进行远程评估。计划使用Oura环(大uraHealthOy)进行客观的睡眠数据收集;但是,因为COVID-19大流行的封锁是在招募开始后才开始的,这个计划无法实现。使用数字行为改变干预参与量表和对子样本的定性电话采访来评估参与者对应用程序的参与。
结果:共有101名参与者参加了试验,21人(21%)接受了定性访谈.随着时间的推移,两组的睡眠质量都有所改善。干预组失眠严重程度指数评分平均提高2.5,对照组平均提高1.6(组间平均差0.9,95%CI-2.0至3.8),组无显著影响(P=.91)。应用程序用户的参与度参差不齐,定性采访支持一个强烈喜欢或不喜欢这款应用的两极分化样本的观点。
结论:在本试验中,干预和控制臂的自我报告睡眠随着时间的推移而改善,没有团体的影响,暗示睡眠应用程序没有效果。定性数据表明,人们对喜欢或不喜欢该应用程序有两极化的看法,人们参与的特征,和需要改进的地方。未来的工作可能涉及开发应用程序功能,然后在更大的样本中使用客观的睡眠测量来测试应用程序。
背景:ClinicalTrials.govNCT04487483;https://www.clinicaltrials.gov/研究/NCT04487483。
BACKGROUND: A third of adults in Western countries have impaired sleep quality. A possible solution involves distributing sleep aids through smartphone apps, but most empirical studies are limited to small pilot trials in distinct populations (eg, soldiers) or individuals with clinical sleep disorders; therefore, general population data are required. Furthermore, recent research shows that sleep app users desire a personalized approach, offering an individually tailored choice of techniques. One such aid is Peak Sleep, a smartphone app based on scientifically validated principles for improving sleep quality, such as mindfulness meditation and cognitive behavioral therapy.
OBJECTIVE: We aimed to test the impact of the smartphone app Peak Sleep on sleep quality and collect user experience data to allow for future app development.
METHODS: This was a 2-arm pilot randomized controlled trial. Participants were general population adults in the United Kingdom (aged ≥18 years) who were interested in improving their sleep quality and were not undergoing clinical treatment for sleep disorder or using sleep medication ≥1 per week. Participants were individually randomized to receive the intervention (3 months of app use) versus a no-treatment control. The intervention involved free access to Peak Sleep, an app that offered a choice of behavioral techniques to support better sleep (mindfulness, cognitive behavioral therapy, and acceptance commitment therapy). The primary outcome was sleep quality assessed using the Insomnia Severity Index at baseline and 1-, 2-, and 3-month follow-ups. Assessments were remote using web-based questionnaires. Objective sleep data collection using the Oura Ring (Ōura Health Oy) was planned; however, because the COVID-19 pandemic lockdowns began just after recruitment started, this plan could not be realized. Participant engagement with the app was assessed using the Digital Behavior Change Intervention Engagement Scale and qualitative telephone interviews with a subsample.
RESULTS: A total of 101 participants were enrolled in the trial, and 21 (21%) were qualitatively interviewed. Sleep quality improved in both groups over time, with Insomnia Severity Index scores of the intervention group improving by a mean of 2.5 and the control group by a mean of 1.6 (between-group mean difference 0.9, 95% CI -2.0 to 3.8), with was no significant effect of group (P=.91). App users\' engagement was mixed, with qualitative interviews supporting the view of a polarized sample who either strongly liked or disliked the app.
CONCLUSIONS: In this trial, self-reported sleep improved over time in both intervention and control arms, with no impact by group, suggesting no effect of the sleep app. Qualitative data suggested polarized views on liking or not liking the app, features that people engaged with, and areas for improvement. Future work could involve developing the app features and then testing the app using objective measures of sleep in a larger sample.
BACKGROUND: ClinicalTrials.gov NCT04487483; https://www.clinicaltrials.gov/study/NCT04487483.