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

NCT04089007 | Completed

• 1 other identifier: MOP-136818
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Deprivation

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Recruitment rate

  Through study completion, an average of 6 weeks

• Data completion rates

  Through study completion, an average of 6 weeks

Other Outcomes (13)

• Change in nocturnal school night sleep duration

  Baseline (week 1) to Follow up (week 5)

• Change in nocturnal weekend sleep duration

  Baseline (week 1) to Follow up (week 5)

• Change in daytime school night sleep

  Baseline (week 1) to Follow up (week 5)

Study Arms (2)

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).

Device: SOmNI app

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.

Other: Control group

Interventions

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.

SOmNI intervention group

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.

Control group

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

University of Toronto

Toronto, Ontario, M5T 1P8, Canada

Location

MeSH Terms

Conditions

Sleep Deprivation

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Robyn Stremler, RN, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: September 13, 2019
• Study Start: January 26, 2018
• Primary Completion: June 28, 2018
• Study Completion: June 28, 2018
• Last Updated: November 19, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)