University of Toronto
Toronto, Ontario, M5T 1P8, Canada
NCT Number: NCT04089007
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.
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Notify Me13 year–17 year
All sexes
Interventional
Not applicable
Toronto, Ontario, M5T 1P8, Canada
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
In addition to allowing users to track sleep behaviours across the four-week intervention period, the SOmNI app will also provide messaging via alerts and tips to outline the importance of sleep to health, suggest optimal sleep timing/duration, and suggest sleep promotion strategies. Daily review questions in the app will help the participants link changes in sleep behaviours to changes in health outcomes. As well, when goals related to sleep extension are met, the SOmNI rewards program awards points to the participant and these points can then be redeemed in $5 increments to a maximum of $40 for gift certificates.
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.
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)
Time frame: Through study completion, an average of 6 weeks
Dropout rate (percentage of participants who withdrew from the study groups)
Time frame: Through study completion, an average of 6 weeks
Percent of those eligible approached to participate who gave consent
Time frame: Through study completion, an average of 6 weeks
Percent of participants who completed study measurements (actigraphy, sleep diary)
Time frame: Baseline (week 1) to Follow up (week 5)
Mean minutes of nocturnal (9pm to 9am) school night sleep (averaged over 5 nights Sun-Thurs)
Time frame: Baseline (week 1) to Follow up (week 5)
Mean minutes of nocturnal (9pm to 9am) weekend sleep (averaged over two nights -Fri-Sat)
Time frame: Baseline (week 1) to Follow up (week 5)
Mean minutes of daytime (9am to 9pm) school night sleep (averaged over five days -Mon-Fri)
Time frame: Baseline (week 1) to Follow up (week 5)
Mean minutes of daytime (9am to 9pm) weekend sleep (averaged over two days -Sat-Sun)
Time frame: Baseline (week 1) to Follow up (week 5)
Epworth Sleepiness Scale (minimum to maximum scores range from 0-24; values >10 represent excessive daytime sleepiness)
Time frame: Baseline (week 1) to Follow up (week 5)
School sleep habits survey
Time frame: Baseline (week 1) to Follow up (week 5)
Sleep Hygiene Index
Time frame: Baseline (week 1) to Follow up (week 5)
Speilberger State Trait Anxiety Inventory -State portion
Time frame: Baseline (week 1) to Follow up (week 5)
Center for Epidemiological Studies Depression scale (minimum to maximum scores range from 0-60; values >16 indicate possible clinical depression)
Time frame: Baseline (week 1) to Follow up (week 5)
Questionnaire asking participants if they accidentally injured themselves (e.g. cuts, strains, falls) in the last 4 weeks
Time frame: Baseline (week 1) to Follow up (week 5)
Questionnaire asking participants if they arrived to school late on mornings in the last 4 weeks
Time frame: Baseline (week 1) to Follow up (week 5)
Height (meters) and weight (kg) will be used to calculate BMI (kg/meters squared)
Time frame: Baseline (week 1) to Follow up (week 5)
Blood pressure will be taken using a manual sphygmomanometer
University of Toronto
Other
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
Acronym: SOmNI
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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