The Effects of a Personalized Sleep Improvement Smartphone Application From SleepScore Labs: A Single-blinded Randomized Waitlist Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 637
- 试验地点
- 1
- 主要终点
- Change in SF B Sleep Quality From Baseline to 6 Weeks
研究概览
简要总结
The study is a single-blinded randomized waitlist controlled trial that aims to assess changes in objective and self-report sleep improvement through use of a dynamic and personalized sleep improvement smartphone app and advice engine in those with poor sleep (i.e., subclinical threshold insomnia) when compared to a waitlist control group after 6 weeks and 12 weeks.
详细描述
Subclinical sleep dysfunction has a multitude of causes (e.g., environmental, cognitive, behavioral, or physiological) and symptoms (e.g., long sleep onset latency, short sleep duration, elevated wake after sleep onset and nighttime awakenings, poor sleep quality). A personalized and dynamic sleep improvement intervention tailored to an individual's lifestyle and specific needs may therefore be required to help nudge those with poor sleep towards sleep-promoting behaviors and attitudes. Digital and mobile health platforms are also highly scalable and cost-effective, thus allowing for widespread implementation across larger subclinical populations.
The purpose of the present study is to conduct a single-blinded randomized waitlist controlled trial to evaluate a novel smartphone application, Dein Schlaf. Dein Tag. powered by SleepScore, designed to both objectively measure and improve sleep. The Dein Schlaf. Dein Tag. app features a validated sonar sleep measurement tool and also provides dynamic and personalized sleep advice founded in the principles of cognitive behavioral psychology and sleep hygiene, offering a non-invasive and non-pharmacological behavioral intervention designed to improve sleep and circadian functioning in those with common sleeping difficulties. Participants will be randomly assigned to the sleep improvement app intervention or a waitlist control group. Online assessments on validated sleep and preventative health measures will take place at baseline, 6 weeks, and 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Sub-clinical threshold insomnia symptoms (Regensburg Insomnia Scale Score 13-24)
- •≥ 18 years old.
- •Naive to the SleepScore Labs App
- •Able to fully understand information on data protection and provide written informed consent
排除标准
- •Non-iOS device users due to technical restrictions of the application
- •Bedtime less than 6 hours
- •Any of the following medical problems:
- •Untreated psychological disorder affecting sleep (e.g., depression, anxiety disorders, bipolar disorder, schizophrenia)
- •Current severe medical conditions (e.g. chronic pain, cancer)
- •Any of the following medications/substance use:
- •Prescription sleep medications or regular use of over-the-counter sleep medications
- •Medication for other conditions (e.g., anxiety, ADHD) that affect sleep, e.g. antidepressants, antipsychotics
- •Consumption of 3+ units of alcohol on 4 or more nights per week
- •Recreational or nightly drug use
- •Pregnant or nursing mothers
- •Shift work
- •Travel across 2 or more time zones during study period
- •Sleeping more than 7 nights not at home during study period
- •Users who newly received a diagnosis of a sleep disorders
- •Users who start sleep or other psychoactive medication during the study period
- •Use of other Sleep Tracking App's during the study period
研究组 & 干预措施
Allocation to Sleep Improvement App
Participants will be instructed to engage with the Dein Schlaf. Dein Tag. smartphone app, log their behaviors in-app, and track their sleep daily for the duration of the study (12 weeks). Participants will be instructed to start the sleep tracking device via their iOS device before lying down in bed and turning off the lights to go to sleep. In the morning, participants will turn off the sleep tracking device as soon as they wake up and decide to leave the bed. At the three time points (baseline, 6 weeks, and 12 weeks), participants will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health)
干预措施: Dein Schlaf. Dein Tag. sleep improvement application powered by SleepScore (Behavioral)
Allocation to Waitlist Control Group
At the three time points (baseline, 6 weeks, and 12 weeks) participants assigned to the wait-list control group will be instructed to complete online assessments on self-reported sleep quality, health perception, psychosocial factors and sleep-permissive behaviors (i.e., preventative health)
结局指标
主要结局
Change in SF B Sleep Quality From Baseline to 6 Weeks
时间窗: Baseline and 6 weeks
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
Change in SF B Sleep Quality From Baseline to 12 Weeks
时间窗: Baseline and 12 weeks
SF B Sleep Quality (SQ): SF B (Görtelmeyer). Range 1-5; higher = better sleep quality.
次要结局
- Changes in Overall Sleep Problems From Baseline to 6 Weeks(Baseline and 6 weeks)
- Changes in Feeling of Being Refreshed in the Morning From Baseline to 6 Weeks(Baseline and 6 weeks)
- Changes in Health Measures From Baseline to 6 Weeks(Baseline and 6 weeks)
- Changes in Feeling of Being Refreshed in the Morning From Baseline to 12 Weeks(Baseline and 12 weeks)
- Changes in Health Measures From Baseline to 12 Weeks(Baseline and 12 weeks)
- Changes in Mental Health Stress From Baseline to 6 Weeks(Baseline and 6 weeks)
- Changes in Overall Sleep Problems From Baseline to 12 Weeks(Baseline and 12 weeks)
- Changes in Mental Health Stress From Baseline to 12 Weeks(Baseline and 12 weeks)