Feasibility, Acceptability and Effectiveness of the SOmNI (Sleep Outcomes, Mhealth, Wearable Sensors and Nudging Intervention) Mobile Phone App for Sleep Promotion in Adolescents: SOmNI Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Compliance rate
研究概览
简要总结
This study evaluates the acceptability, feasibility, and efficacy of an intervention using wearable sensors and a mHealth application, SOmNI, to promote sleep for adolescents. The investigators hypothesize that a behavioural intervention delivered through a mobile app will be a cost-effective and accessible method of engaging adolescents in the self-management of sleep behaviours. Participants will be randomized to either the SOmNI Intervention group or the Control group. Participants receiving the SOmNI app will attempt to incrementally move their school night bedtime earlier in the evening.
详细描述
Over 60% of adolescents sleep less than the 9 hours of sleep recommended for 13-18 year olds. Quality of life is reduced due to the daytime consequences of chronic sleep deprivation such as sleepiness, fatigue, low mood, and inattentiveness at school. Although this sleep debt occurs in otherwise healthy adolescents, it significantly increases their risk of development of the chronic health conditions (cardiovascular disease and depression) and forms of accidental injury (motor vehicle accidents) that place the greatest demands on our health care system. Despite increased recognition of adequate sleep as a key contributor to health, there exist few effective interventions to promote sleep in adolescents. This study is designed to determine compliance, feasibility and preliminary data on health outcomes (nocturnal sleep measured objectively by actigraphy; daytime sleepiness; anxiety; depression; unintentional injuries; morning school attendance). This study will be a pilot RCT, randomizing 76 adolescents to one of two groups (i.e. 38 per group). Study arms will include a control group and intervention group (activity monitoring device with custom application). Mobile health, user-friendly low-intensity interventions with wearable sleep sensors and tailored feedback may help many adolescents to increase the amount of sleep they achieve.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •enrolled in high school (grades 9 to 12)
- •ages 13-17 years
- •report sleeping <8 hours per weeknight (Sun-Thurs)
- •endorse daytime sleepiness that interferes with their daily function to a moderate or severe degree (e.g. To what extent do you consider your sleepiness to interfere with your daily functioning (e.g. daytime fatigue, mood, ability to function at school, concentration, memory)
- •report sleeping >9 hours on weekend nights (Fri-Sat)
- •have either their own iPhone (version 4S or higher) or are willing to use a study-provided iPhone
排除标准
- •developmental delay (e.g. more than one grade level beyond what is appropriate for age)
- •physician-diagnosed, significant physical health problem (e.g. cystic fibrosis, diabetes, lupus, kidney disease, hypertension, inflammatory bowel disease, etc)
- •physician-diagnosed mental health problem (e.g. anxiety, depression, ADHD),
- •physician-diagnosed sleep disorder (e.g. narcolepsy, obstructive sleep apnea, insomnia, restless leg syndrome)
- •suspected sleep disordered breathing problem as identified by screening with questions from the Pediatric Sleep Questionnaire
- •suspected insomnia based on screening with questions from the Insomnia Severity Index
- •suspected Restless Leg Syndrome based on screening with the International RLS Study Group questionnaire
- •suspected delayed sleep phase syndrome as evidenced by consistent inability to fall asleep before 01h00 to 06h00, significant impairment in the ability to attend school due to extreme delay of their sleep schedule, and avoidance of other social or family functions in the daytime
研究组 & 干预措施
SOmNI intervention group
Participants will receive an iPhone with the SOmNI app and will be instructed to move their bedtime earlier by 5 minutes (from their average baseline week bedtime) on each school night (Sunday to Thursday). Participants will also be given sleep hygiene information related to the embedded features of the SOmNI app. A research assistant will help the participant to enter the appropriate goal bedtime in the SOmNI app and orient them to the features of the SOmNI app. Participants will also be instructed to aim for <1 hour difference between school night and weekend bedtimes and wake times (i.e. avoid staying up late and sleeping in on weekends).
The SOmNI application will allow the user to graphically track sleep behaviour across the four-week intervention period as recorded by the wearable sensor (e.g. bedtimes, wake times, amount of sleep achieved will all be displayed in the app).
干预措施: SOmNI app (Device)
Control group
The research assistant will advise the participant to increase the amount of nighttime sleep achieved but will not give any sleep hygiene advice or instructions for moving their bedtime earlier.
干预措施: Control group (Other)
结局指标
主要结局
Compliance rate
时间窗: Through study completion, an average of 6 weeks
Compliance rate (percentage of participants assigned to intervention group who used SOMNI app to monitor sleep)
Dropout rate
时间窗: Through study completion, an average of 6 weeks
Dropout rate (percentage of participants who withdrew from the study groups)
次要结局
- Recruitment rate(Through study completion, an average of 6 weeks)
- Data completion rates(Through study completion, an average of 6 weeks)
研究者
Robyn Stremler
Associate Professor
University of Toronto