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

November 18, 2020 updated by: Robyn Stremler, University of Toronto

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T 1P8
        • University of Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: SOmNI intervention group

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
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.
ACTIVE_COMPARATOR: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Through study completion, an average of 6 weeks
Dropout rate
Time Frame: Through study completion, an average of 6 weeks
Dropout rate (percentage of participants who withdrew from the study groups)
Through study completion, an average of 6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Recruitment rate
Time Frame: Through study completion, an average of 6 weeks
Percent of those eligible approached to participate who gave consent
Through study completion, an average of 6 weeks
Data completion rates
Time Frame: Through study completion, an average of 6 weeks
Percent of participants who completed study measurements (actigraphy, sleep diary)
Through study completion, an average of 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
Baseline (week 1) to Follow up (week 5)
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)
Baseline (week 1) to Follow up (week 5)
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)
Baseline (week 1) to Follow up (week 5)
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)
Baseline (week 1) to Follow up (week 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)
Baseline (week 1) to Follow up (week 5)
Change in sleep quality
Time Frame: Baseline (week 1) to Follow up (week 5)
School sleep habits survey
Baseline (week 1) to Follow up (week 5)
Change in sleep hygiene
Time Frame: Baseline (week 1) to Follow up (week 5)
Sleep Hygiene Index
Baseline (week 1) to Follow up (week 5)
Change in anxiety
Time Frame: Baseline (week 1) to Follow up (week 5)
Speilberger State Trait Anxiety Inventory -State portion
Baseline (week 1) to Follow up (week 5)
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)
Baseline (week 1) to Follow up (week 5)
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
Baseline (week 1) to Follow up (week 5)
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
Baseline (week 1) to Follow up (week 5)
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)
Baseline (week 1) to Follow up (week 5)
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
Baseline (week 1) to Follow up (week 5)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robyn Stremler, RN, PhD, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 28, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MOP-136818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sleep Deprivation

Clinical Trials on SOmNI app

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings