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

Primary Purpose

Sleep Deprivation

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

SOmNI app

Control group

About this trial

This is an interventional other trial for Sleep Deprivation

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of Toronto

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SOmNI intervention group

Control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Compliance rate

Compliance rate (percentage of participants assigned to intervention group who used SOMNI app to monitor sleep)

Dropout rate

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

Secondary Outcome Measures

Recruitment rate

Percent of those eligible approached to participate who gave consent

Data completion rates

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

Full Information

NCT ID

NCT04089007

First Posted

April 5, 2018

Last Updated

November 18, 2020

Sponsor

University of Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT04089007

Brief Title

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

Acronym

SOmNI

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 26, 2018 (Actual)

Primary Completion Date

June 28, 2018 (Actual)

Study Completion Date

June 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Toronto

Collaborators

Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Deprivation

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

65 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOmNI intervention group

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

SOmNI app

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Control group

Intervention Description

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 Outcome Measure Information:

Title

Compliance rate

Description

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

Title

Dropout rate

Description

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

Time Frame

Through study completion, an average of 6 weeks

Secondary Outcome Measure Information:

Title

Recruitment rate

Description

Percent of those eligible approached to participate who gave consent

Time Frame

Through study completion, an average of 6 weeks

Title

Data completion rates

Description

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

Time Frame

Through study completion, an average of 6 weeks

Other Pre-specified Outcome Measures:

Title

Change in nocturnal school night sleep duration

Description

Mean minutes of nocturnal (9pm to 9am) school night sleep (averaged over 5 nights Sun-Thurs)

Time Frame