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
- ResMed
- 入组人数
- 637
- 试验地点
- 2
- 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
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)