Digital Sleep Interventions for Adolescent Sleep Irregularities
(SHEETS Trial)
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.12345Why 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.12678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Focus Group Participation
Participants and their guardian participate in a focus group to provide feedback on the intervention
Treatment
Participants undergo a 6-week digital sleep intervention, including wearing a Garmin and completing a sleep diary
Follow-up
Participants are monitored for sleep regularity and psychiatric health at 3 and 6 months post-intervention
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?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator
Citations
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 ...
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 ...
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 ...
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.
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.
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