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Sustainable Habits for Encouraging Even Teen Sleep (SHEETS)

Duke University logo

Duke University

Status

Completed

Conditions

Psychiatric Health
Sleep

Treatments

Behavioral: Garmin, Pattern Health App

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT05378373
Pro00109013
1R34MH128440-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

61 patients

Sex

All

Ages

12 to 14 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

61 participants in 2 patient groups

SHEETS Arm 1
Active Comparator group
Description:
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Treatment:
Behavioral: Garmin, Pattern Health App
SHEETS Arm 2
Experimental group
Description:
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Treatment:
Behavioral: Garmin, Pattern Health App

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Shubha Parekh

Data sourced from clinicaltrials.gov

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