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| Name | Class |
|---|---|
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOmNI intervention group | Experimental | 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). |
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| Control group | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOmNI app | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance rate | Compliance rate (percentage of participants assigned to intervention group who used SOMNI app to monitor sleep) | Through study completion, an average of 6 weeks |
| Dropout rate | Dropout rate (percentage of participants who withdrew from the study groups) | Through study completion, an average of 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | Percent of those eligible approached to participate who gave consent | Through study completion, an average of 6 weeks |
| Data completion rates | Percent of participants who completed study measurements (actigraphy, sleep diary) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nocturnal school night sleep duration | Mean minutes of nocturnal (9pm to 9am) school night sleep (averaged over 5 nights Sun-Thurs) | Baseline (week 1) to Follow up (week 5) |
| Change in nocturnal weekend sleep duration |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robyn Stremler, RN, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Toronto | Toronto | Ontario | M5T 1P8 | Canada |
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| ID | Term |
|---|---|
| D012892 | Sleep Deprivation |
| ID | Term |
|---|---|
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
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| Control group | Other | 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. |
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| Through study completion, an average of 6 weeks |
Mean minutes of nocturnal (9pm to 9am) weekend sleep (averaged over two nights -Fri-Sat)
| Baseline (week 1) to Follow up (week 5) |
| Change in daytime school night sleep | Mean minutes of daytime (9am to 9pm) school night sleep (averaged over five days -Mon-Fri) | Baseline (week 1) to Follow up (week 5) |
| Change in daytime weekend sleep | Mean minutes of daytime (9am to 9pm) weekend sleep (averaged over two days -Sat-Sun) | Baseline (week 1) to Follow up (week 5) |
| Change in daytime sleepiness | Epworth Sleepiness Scale (minimum to maximum scores range from 0-24; values >10 represent excessive daytime sleepiness) | Baseline (week 1) to Follow up (week 5) |
| Change in sleep quality | School sleep habits survey | Baseline (week 1) to Follow up (week 5) |
| Change in sleep hygiene | Sleep Hygiene Index | Baseline (week 1) to Follow up (week 5) |
| Change in anxiety | Speilberger State Trait Anxiety Inventory -State portion | Baseline (week 1) to Follow up (week 5) |
| Change in depression | Center for Epidemiological Studies Depression scale (minimum to maximum scores range from 0-60; values >16 indicate possible clinical depression) | Baseline (week 1) to Follow up (week 5) |
| Change in unintentional injuries | Questionnaire asking participants if they accidentally injured themselves (e.g. cuts, strains, falls) in the last 4 weeks | Baseline (week 1) to Follow up (week 5) |
| Change in morning school attendance | Questionnaire asking participants if they arrived to school late on mornings in the last 4 weeks | Baseline (week 1) to Follow up (week 5) |
| Change in Body Mass Index | Height (meters) and weight (kg) will be used to calculate BMI (kg/meters squared) | Baseline (week 1) to Follow up (week 5) |
| Change in Blood Pressure (mm Hg) | Blood pressure will be taken using a manual sphygmomanometer | Baseline (week 1) to Follow up (week 5) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D008722 | Methods |