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Completed

NCT Number: NCT05378373

Sustainable Habits for Encouraging Even Teen Sleep

This study will examine the feasibility, acceptability, and effectiveness of two digital sleep interventions in improving sleep regularity and psychiatric health during a critical period of adolescence.

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Key information

Age range

12 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Children's Primary Care North Durham

Durham, North Carolina, 27704, United States

About this study

This study will be testing two digital sleep health interventions for adolescents. Adolescents in both conditions will receive sleep education-related content. This project also uses an innovative digital platform and wearable sensors to deliver feedback.

The purpose of this research study is to evaluate a 6-week digital sleep intervention to promote healthy sleep patterns. The study will be broken up into two phases: Phase 1: Focus group participation. Participants and their guardian will be asked to participate in a focus group to get their thoughts/opinions on the intervention. Phase 2: Participants and their guardian will be asked to come to 4 different study visits: baseline, post-intervention, 3 month and 6 month follow up. Participants will be asked to complete questionnaires about demographics, psychiatric health, and sleep patterns. The participants will be asked to wear an ActiGraph watch for 24hrs/day for a week for 4 separate weeks, a Garmin for the duration of the 6-week intervention and keep a sleep diary through an online program.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • ages 12-14 years
  • parent concern on the routines/consistency subscale of the Pediatric Sleep Practices Questionnaire, indicating poor sleep practices (score of 2) in at least one of the following: bedtime consistency, wake time consistency, and bedtime routines;
  • ability to speak, read and write in English
  • access to internet and smartphone device with capacity to download intervention App (iOS and Android)
  • valid email address
  • ability to follow written and verbal instructions
  • ability and willingness to comply with study procedures.

Exclusion criteria

  • diagnosed sleep disorder
  • psychiatric disorder under treatment (medication and/or therapy) or intellectual disability
  • chronic pain condition interfering with sleep
  • substance use disorder
  • use of medication for sleep (prescription or over-the-counter)
  • has a sibling also enrolled/participating in the same study

Treatment and study plan

Garmin, Pattern Health App

Behavioral

Wearable sensors will deliver individualized feedback to participants according to their assigned intervention

Primary outcomes

  1. Change in Sleep Regularity Index (SRI)

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    A measure of sleep regularity collected continuously over 7 days via actigraphy. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.

  2. Feasibility as Measured by Recruitment Percentage

    Time frame: 6 months

    The number of participants consenting (and assenting) divided by the number who were invited (i.e., passed the telephone prescreen) x 100 to produce a percentage.

  3. Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment

    Time frame: 6 weeks, 3 months, 6 months

  4. Acceptability as the Average Adherence Rate

    Time frame: 6 weeks

    Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.

Secondary outcomes

  1. Change in Self-Reported Sleep Health

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    Self-reported sleep will be assessed via the PROMIS pediatric sleep disturbances survey, an 8 item survey (each item is on a 5-point Likert scale ranging from Never to Always). The total score ranges from 0 to 32, where lower scores indicate better outcomes.

  2. Change in Adolescent Reported Psychiatric Health - Internalizing

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    As measured by the Youth Self Report, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes.

  3. Change in Parent Reported Psychiatric Health - Internalizing

    Time frame: Baseline, 6 weeks, 3 months, 6 months

    As measured by the Child Behavior Checklist, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes.

  4. Sleep Regularity Index (SRI) as Measured by Garmin

    Time frame: 6 weeks

    A measure of sleep regularity collected continuously over 7 days via Garmin. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents

Acronym: SHEETS

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 18, 2022
Registry last updated
Jul 10, 2026

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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