Sleep Deprivation
Conditions
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.
Interventions
DEVICESOmNI app
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.
OTHERControl group
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance rate | 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 | Through study completion, an average of 6 weeks | Dropout rate (percentage of participants who withdrew from the study groups) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Data completion rates | Through study completion, an average of 6 weeks | Percent of participants who completed study measurements (actigraphy, sleep diary) |
| Recruitment rate | Through study completion, an average of 6 weeks | Percent of those eligible approached to participate who gave consent |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in daytime sleepiness | 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) |
| Change in sleep quality | Baseline (week 1) to Follow up (week 5) | School sleep habits survey |
| Change in sleep hygiene | Baseline (week 1) to Follow up (week 5) | Sleep Hygiene Index |
| Change in anxiety | Baseline (week 1) to Follow up (week 5) | Speilberger State Trait Anxiety Inventory -State portion |
| Change in nocturnal school night sleep duration | Baseline (week 1) to Follow up (week 5) | Mean minutes of nocturnal (9pm to 9am) school night sleep (averaged over 5 nights Sun-Thurs) |
| Change in unintentional injuries | 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 |
| Change in morning school attendance | Baseline (week 1) to Follow up (week 5) | Questionnaire asking participants if they arrived to school late on mornings in the last 4 weeks |
| Change in Body Mass Index | Baseline (week 1) to Follow up (week 5) | Height (meters) and weight (kg) will be used to calculate BMI (kg/meters squared) |
| Change in Blood Pressure (mm Hg) | Baseline (week 1) to Follow up (week 5) | Blood pressure will be taken using a manual sphygmomanometer |
| Change in depression | 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) |
| Change in nocturnal weekend sleep duration | Baseline (week 1) to Follow up (week 5) | Mean minutes of nocturnal (9pm to 9am) weekend sleep (averaged over two nights -Fri-Sat) |
| Change in daytime school night sleep | Baseline (week 1) to Follow up (week 5) | Mean minutes of daytime (9am to 9pm) school night sleep (averaged over five days -Mon-Fri) |
| Change in daytime weekend sleep | Baseline (week 1) to Follow up (week 5) | Mean minutes of daytime (9am to 9pm) weekend sleep (averaged over two days -Sat-Sun) |
Countries
Canada
Outcome results
None listed