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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two digital tools to help teens sleep better and improve their mental health. Participants will use a Garmin device (a wearable fitness tracker) and a Pattern Health App. One group will learn about sleep schedules, while another will learn how factors like exercise affect sleep. The trial targets 12 to 14-year-olds who struggle with regular sleep routines and whose parents are concerned about their sleep consistency. Teens must have access to a smartphone and internet to participate. As an unphased trial, this study provides a unique opportunity for teens to enhance their sleep and mental health using innovative digital tools.

Will I have to stop taking my current medications?

If you are using medication for sleep, you cannot participate in this study. The trial excludes participants who are currently using sleep medications.

What prior data suggests that these digital sleep interventions are safe for adolescents?

Research has shown that consumer sleep-tracking devices, like the Garmin, effectively detect sleep. They often perform as well as or better than actigraphy, a method for monitoring sleep and activity, in identifying wakefulness. This is promising for safety, as these devices are commonly used in everyday life and are generally considered safe.

Studies have examined similar app-based sleep tools for the Pattern Health App. Teenagers using these apps reported better sleep patterns. These apps are designed to be user-friendly and safe, focusing on improving sleep habits without causing harm.

Both the Garmin device and the Pattern Health App are widely used and well-tolerated. Similar studies have reported no major negative effects, suggesting these digital sleep tools are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the digital sleep interventions using the Garmin and Pattern Health App for adolescent sleep irregularities because these treatments offer a fresh approach to improving sleep habits. Unlike traditional methods, which often involve medications or in-person therapy sessions, these digital tools provide accessible and personalized sleep education through mobile technology. The Garmin device can monitor sleep patterns and provide real-time feedback, while the Pattern Health App offers interactive content to help teens learn about healthy sleep routines. This combination of technology and education empowers adolescents to take control of their sleep health in a convenient and engaging way.

What evidence suggests that these digital sleep interventions are effective for adolescent sleep irregularities?

In this trial, participants will use either Garmin devices or the Pattern Health App in separate treatment arms. Research has shown that Garmin devices yield mixed results in tracking sleep. While they may not always be accurate for individuals, they perform better when assessing sleep patterns in groups, particularly for measuring total sleep time. Conversely, the Pattern Health App has demonstrated effectiveness in addressing sleep problems like insomnia, with improvements lasting up to six months. Both tools aim to support better sleep habits through education and tracking, potentially helping teenagers improve their sleep patterns and mental health. Early studies suggest these tools could be beneficial, but results may vary among individuals. ^{1 2 6 7 8}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11406596/

Evaluation of the Garmin Vivofit 4 for assessing sleep in youth ... The Vivofit 4 showed consistently poor individual-level validity, while group-level validity was better for some variables (total sleep time and sleep ...

2. garmin.com garmin.com/en-US/blog/health/the-science-of-sleep-garmin-health-at-the-forefront-of-sleep-research-initiatives/

Garmin Health at the forefront of sleep research initiatives We'll explore the impacts of social media detox on sleep in teenagers, a comprehensive investigation into university students' sleep behavior ...

3. garmin.com garmin.com/en-US/blog/fitness/how-well-do-you-sleep-new-data-examines-garmin-users-sleep/

How well do you sleep? New data examines Garmin users ... The average sleep score of all Garmin users improved in 2024 from 70 to 72. Elite athletes sleep better than the rest of us, with an average ...

4. researchgate.net researchgate.net/publication/384068504_Evaluation_of_the_Garmin_Vivofit_4_for_assessing_sleep_in_youth_experiencing_sleep_disturbances

(PDF) Evaluation of the Garmin Vivofit 4 for assessing ... Garmin sleep efficiency averaged 3.3% ± 13.8% lower than polysomnography. Minutes in light sleep and deep sleep (the latter including rapid eye movement) were ...

5. mdpi.com mdpi.com/1424-8220/24/2/635

Evaluating Accuracy in Five Commercial Sleep-Tracking ... The Withings Mat and Garmin Vivosmart overestimated shorter light sleep and underestimated longer light sleep. The Oura Ring underestimated ...

6. garmin.com garmin.com/en-GB/blog/the-science-of-sleep-garmin-health-at-the-forefront-of-sleep-research-initiatives/

Garmin Health at the Forefront of Sleep Research Initiatives We'll explore the impacts of social media detox on sleep in teenagers, a comprehensive investigation into university students' sleep behaviour ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8120339/

Performance of seven consumer sleep-tracking devices ... Consumer sleep-tracking devices exhibited high performance in detecting sleep, and most performed equivalent to (or better than) actigraphy in detecting wake.

8. garmin.com garmin.com/en-US/blog/health/garmin-fitness-trackers-help-researchers-understand-sleep-issues-for-rare-disease-patients/

Garmin Fitness Trackers Help Researchers Understand ... In this study, Aparito investigated the use of Garmin fitness trackers to assess sleep quality in individuals affected by dystonia.