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Digital Sleep Interventions for Adolescent Sleep Irregularities (SHEETS Trial)

N/A
Recruiting
Led By Jessica Lunsford-Avery, Ph.D.
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Access to internet and smartphone device with capacity to download intervention App (iOS and Android)
Ages 12-14 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks, 3 months, 6 months
Awards & highlights

SHEETS Trial Summary

This trial will test two digital sleep interventions to see if they improve sleep regularity and psychiatric health in adolescents.

Who is the study for?
This trial is for teens aged 12-14 who have inconsistent sleep patterns as noted by their parents. Participants must speak English, have internet and a smartphone to download an app, and be able to follow instructions. Teens with diagnosed sleep disorders, substance use issues, or under treatment for psychiatric disorders are not eligible.Check my eligibility
What is being tested?
The study tests two digital interventions using the Garmin device and Pattern Health App to see if they can help improve regularity in sleep habits and mental health among adolescents during a key developmental stage.See study design
What are the potential side effects?
Since this trial involves non-medical interventions focusing on digital tools to encourage better sleep habits, there may not be direct side effects like those associated with medications; however, increased screen time could potentially affect sleep quality.

SHEETS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have a smartphone and can download apps.
Select...
I am between 12 and 14 years old.

SHEETS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 6 weeks, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability as measured by activity completion
Change in Sleep Regularity Index (SRI)
Feasibility as measured by Recruitment rate
+1 more
Secondary outcome measures
Change in Adolescent Reported Psychiatric Health
Change in Parent Reported Psychiatric Health
Change in Self-Reported Sleep Health
+1 more

SHEETS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: SHEETS Arm 2Experimental Treatment1 Intervention
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Group II: SHEETS Arm 1Active Control1 Intervention
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,717 Total Patients Enrolled
8 Trials studying Sleep
1,614 Patients Enrolled for Sleep
Duke UniversityLead Sponsor
2,363 Previous Clinical Trials
3,420,436 Total Patients Enrolled
5 Trials studying Sleep
1,169 Patients Enrolled for Sleep
Jessica Lunsford-Avery, Ph.D.Principal InvestigatorDuke University

Media Library

Garmin, Pattern Health App 2023 Treatment Timeline for Medical Study. Trial Name: NCT05378373 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many subjects are participating in this research endeavor?

"Yes, the clinicaltrials.gov website displays that this study is currently recruiting. It was first listed on October 21st 2022 and most recently updated a week later on October 27th 2022. The research team aims to recruit 50 participants from one location for their trial."

Answered by AI

What are the major goals of this investigation?

"During this clinical trial, the primary objective will be to evaluate its feasibility in terms of recruitment rate. Secondary outcomes include changes in Parent Reported Psychiatric Health (assessed via Child Behavior Checklist), Adolescent Reported Psychiatric Health (measured with Youth Self Report) and Self-Reported Sleep Health (monitored via PROMIS pediatric sleep survey). All these measures are rated on a 3 or 5 point Likert scale where lower scores denote better results."

Answered by AI

Are there vacancies in this experiment that participants can fill?

"Affirmative. Per the clinicaltrials.gov website, this research is still searching for test subjects with a listing that was first published on October 21st 2022 and most recently updated on October 27th 2022. A total of 50 people are needed at 1 medical facility."

Answered by AI

Are individuals aged thirty and over eligible to partake in the research trial?

"The requirements for this trial necessitate that participants are aged between 12 to 14 years old. There is a total of 30 trials devoted exclusively to minors, and 87 studies dedicated to seniors above 65."

Answered by AI

Is there a possibility that I could be accepted into this experiment?

"This medical trial requires 50 participants aged between 12 and 14 with a psychiatric background. To be eligible for the study, minors must possess fluency in English, provide valid email address, adhere to instructions both verbal and written form, score 6 or higher on the Pediatric Sleep Practices Questionnaire's routines/consistency subscale, have access to the internet as well as an iOS / Android device capable of downloading the intervention App."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Sustainable Habits for Encouraging Even Teen Sleep
2022. "Sustainable Habits for Encouraging Even Teen Sleep". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05378373.
~7 spots leftby Aug 2024
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