Status:
COMPLETED
Feasibility, Acceptability and Effectiveness of the SOmNI Mobile Phone App for Sleep Promotion in Adolescents
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Sleep Deprivation
Eligibility:
All Genders
13-17 years
Phase:
NA
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 hypoth...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2018
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT04089007
Start Date
January 26 2018
End Date
June 28 2018
Last Update
November 19 2020
Active Locations (1)
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1
University of Toronto
Toronto, Ontario, Canada, M5T 1P8