Digital Sleep Interventions for Adolescent Sleep Irregularities

(SHEETS Trial)

Overseen By Shubha Parekh

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Must not be taking: Sleep medications

Disqualifiers: Sleep disorder, Psychiatric disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

61 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jessica Lunsford-Avery, Ph.D.

Principal Investigator

Duke University

Naomi Duke, M.D.

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Ability to speak, read and write in English

Valid email address

Ability to follow written and verbal instructions

Exclusion Criteria

I use sleep medication.

Has a sibling also enrolled/participating in the same study

I have chronic pain that affects my sleep.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Focus Group Participation

Participants and their guardian participate in a focus group to provide feedback on the intervention

1 week

1 visit (in-person)

Treatment

Participants undergo a 6-week digital sleep intervention, including wearing a Garmin and completing a sleep diary

6 weeks

4 visits (in-person)

Follow-up

Participants are monitored for sleep regularity and psychiatric health at 3 and 6 months post-intervention

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Garmin
• Pattern Health App

Trial Overview 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.

How Is the Trial Designed?

Group I: SHEETS Arm 2 Experimental Treatment 1 Intervention

Participants will receive sleep education-related content to support good sleep, like setting schedules.

Group II: SHEETS Arm 1 Active Control 1 Intervention

Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+