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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sleep Deprivation
- Sponsor
- University of Toronto
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Compliance rate
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Robyn Stremler
Associate Professor
University of Toronto
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Compliance rate
Time Frame: 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
Time Frame: Through study completion, an average of 6 weeks
Dropout rate (percentage of participants who withdrew from the study groups)
Secondary Outcomes
- Recruitment rate(Through study completion, an average of 6 weeks)
- Data completion rates(Through study completion, an average of 6 weeks)