Clinical trial NCT04089007: Feasibility, Acceptability and Effectiveness of the SOmNI Mobile Phone App for Sleep Promotion in Adolescents
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2019-09-13
Enrollment: 65
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Compliance rate
timeFrame: Through study completion, an average of 6 weeks
measure: Dropout rate
timeFrame: Through study completion, an average of 6 weeks
Secondary outcomes:
measure: Recruitment rate
timeFrame: Through study completion, an average of 6 weeks
measure: Data completion rates
timeFrame: Through study completion, an average of 6 weeks
Other outcomes:
measure: Change in nocturnal school night sleep duration
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in nocturnal weekend sleep duration
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in daytime school night sleep
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in daytime weekend sleep
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in daytime sleepiness
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in sleep quality
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in sleep hygiene
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in anxiety
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in depression
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in unintentional injuries
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in morning school attendance
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in Body Mass Index
timeFrame: Baseline (week 1) to Follow up (week 5)
measure: Change in Blood Pressure (mm Hg)
timeFrame: Baseline (week 1) to Follow up (week 5)
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
affiliation: University of Toronto
name: Robyn Stremler, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: