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

Sleep Deprivation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04089007
• Other study ID #: MOP-136818
• Status: Completed
• Phase: N/A
• Start date: January 26, 2018
• Est. completion date: June 28, 2018

Study information

• Verified date: November 2020
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 28, 2018
• Est. primary completion date: June 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Deprivation

Intervention

Device:
• SOmNI 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.

Other:
• Control 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.

Locations

Country	Name	City	State
Canada	University of Toronto	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Change in nocturnal weekend sleep duration	Mean minutes of nocturnal (9pm to 9am) weekend sleep (averaged over two nights -Fri-Sat)	Baseline (week 1) to Follow up (week 5)
Other	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)
Other	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)
Other	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)
Other	Change in sleep quality	School sleep habits survey	Baseline (week 1) to Follow up (week 5)
Other	Change in sleep hygiene	Sleep Hygiene Index	Baseline (week 1) to Follow up (week 5)
Other	Change in anxiety	Speilberger State Trait Anxiety Inventory -State portion	Baseline (week 1) to Follow up (week 5)
Other	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)
Other	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)
Other	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)
Other	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)
Other	Change in Blood Pressure (mm Hg)	Blood pressure will be taken using a manual sphygmomanometer	Baseline (week 1) to Follow up (week 5)
Primary	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
Primary	Dropout rate	Dropout rate (percentage of participants who withdrew from the study groups)	Through study completion, an average of 6 weeks
Secondary	Recruitment rate	Percent of those eligible approached to participate who gave consent	Through study completion, an average of 6 weeks
Secondary	Data completion rates	Percent of participants who completed study measurements (actigraphy, sleep diary)	Through study completion, an average of 6 weeks