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Completed

NCT Number: NCT04089007

Feasibility, Acceptability and Effectiveness of the SOmNI Mobile Phone App for Sleep Promotion in Adolescents

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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Key information

Age range

13 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Toronto

Toronto, Ontario, M5T 1P8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Compliance rate

    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)

  2. Dropout rate

    Time frame: Through study completion, an average of 6 weeks

    Dropout rate (percentage of participants who withdrew from the study groups)

Secondary outcomes

  1. Recruitment rate

    Time frame: Through study completion, an average of 6 weeks

    Percent of those eligible approached to participate who gave consent

  2. Data completion rates

    Time frame: Through study completion, an average of 6 weeks

    Percent of participants who completed study measurements (actigraphy, sleep diary)

Other outcomes

  1. Change in nocturnal school night sleep duration

    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)

  2. Change in nocturnal weekend sleep duration

    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)

  3. Change in daytime school night sleep

    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)

  4. Change in daytime weekend sleep

    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)

  5. Change in daytime sleepiness

    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)

  6. Change in sleep quality

    Time frame: Baseline (week 1) to Follow up (week 5)

    School sleep habits survey

  7. Change in sleep hygiene

    Time frame: Baseline (week 1) to Follow up (week 5)

    Sleep Hygiene Index

  8. Change in anxiety

    Time frame: Baseline (week 1) to Follow up (week 5)

    Speilberger State Trait Anxiety Inventory -State portion

  9. Change in depression

    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)

  10. Change in unintentional injuries

    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

  11. Change in morning school attendance

    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

  12. Change in Body Mass Index

    Time frame: Baseline (week 1) to Follow up (week 5)

    Height (meters) and weight (kg) will be used to calculate BMI (kg/meters squared)

  13. Change in Blood Pressure (mm Hg)

    Time frame: Baseline (week 1) to Follow up (week 5)

    Blood pressure will be taken using a manual sphygmomanometer

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study 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

Acronym: SOmNI

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Sep 13, 2019
Registry last updated
Nov 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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