Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
61 participants
INTERVENTIONAL
2022-10-21
2025-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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SHEETS Arm 1
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
SHEETS Arm 2
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
Interventions
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Garmin, Pattern Health App
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
14 Years
ALL
Yes
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Jessica Lunsford-Avery, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Naomi Duke, M.D.
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke Children's Primary Care North Durham
Durham, North Carolina, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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Pro00109013
Identifier Type: -
Identifier Source: org_study_id
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