SleepSHEETSNCT05378373

Sustainable Habits for Encouraging Even Teen Sleep

A study testing Garmin, Pattern Health App in people with Sleep and Psychiatric Health, run by Duke University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 12 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Sleep, Psychiatric Health
What is being tested?: Garmin, Pattern Health App
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 83 participants
Where: 1 siteUnited States
Study dates: 21 Oct 2022to 31 Jan 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

ages 12-14 years
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.

Who cannot join

diagnosed sleep disorder
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

Trial locations and contacts

1 site in 1 country.

United States1 site

Duke Children's Primary Care North Durham
Durham, North Carolina, 27704

Other trials in United States

About this study

Official title: Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents

Read the detailed description

This study will be testing two digital sleep health interventions for adolescents. Adolescents in both conditions will receive sleep education-related content. This project also uses an innovative digital platform and wearable sensors to deliver feedback.

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: Sleep, Psychiatric Health
Being tested: Garmin, Pattern Health App
Keywords: Adolescents, Sleep, Psychiatric Health, Digital Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Garmin, Pattern Health AppBehavioural
Wearable sensors will deliver individualized feedback to participants according to their assigned intervention

Study groups in NCT05378373
Study group	Role	What they receive
SHEETS Arm 1	Active comparator	Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise. Receives: Behavioral: Garmin, Pattern Health App
SHEETS Arm 2	Experimental	Participants will receive sleep education-related content to support good sleep, like setting schedules. Receives: Behavioral: Garmin, Pattern Health App

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Sleep Regularity Index (SRI)
A measure of sleep regularity collected continuously over 7 days via actigraphy. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.
Measured: Baseline, 6 weeks, 3 months, 6 months
Feasibility as Measured by Recruitment Percentage
The number of participants consenting (and assenting) divided by the number who were invited (i.e., passed the telephone prescreen) x 100 to produce a percentage.
Measured: 6 months
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
Measured: 6 weeks, 3 months, 6 months
Acceptability as the Average Adherence Rate
Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.
Measured: 6 weeks

Secondary outcomes (4)

Change in Self-Reported Sleep Health
Self-reported sleep will be assessed via the PROMIS pediatric sleep disturbances survey, an 8 item survey (each item is on a 5-point Likert scale ranging from Never to Always). The total score ranges from 0 to 32, where lower scores indicate better outcomes.
Measured: Baseline, 6 weeks, 3 months, 6 months
Change in Adolescent Reported Psychiatric Health - Internalizing
As measured by the Youth Self Report, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes.
Measured: Baseline, 6 weeks, 3 months, 6 months
Change in Parent Reported Psychiatric Health - Internalizing
As measured by the Child Behavior Checklist, a 112-item questionnaire, with a 3-point Likert scale ranging from Not True to Very True. The internalizing subscale is based on 31 items. The standardized T-score has a population mean of 50 with a standard deviation of 10. Lower scores indicate better outcomes.
Measured: Baseline, 6 weeks, 3 months, 6 months
Sleep Regularity Index (SRI) as Measured by Garmin
A measure of sleep regularity collected continuously over 7 days via Garmin. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Oct 202231 Jan 2025

First posted18 May 2022
Study start21 Oct 2022
Primary completion31 Jan 2025
Study completion31 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SleepStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Digital Behavioral Intervention
Masking: Single blind
Who is masked: Participant
Enrolment: 83 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05378373
Sponsor's protocol ID: Pro00109013
Other IDs: 1R34MH128440-01
Acronym: SHEETS
Status last verified: Jun 2026
First submitted: 12 May 2022
Last updated: 10 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Adult Participants

All Sleep trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sustainable Habits for Encouraging Even Teen Sleep (SHEETS): A Digital Intervention to Enhance Sleep and Psychiatric Health in Adolescents
ClinicalTrials.gov ID: NCT05378373
Acronym / sponsor ID: SHEETS / Pro00109013
Conditions: Sleep, Psychiatric Health
Keywords: Adolescents, Sleep, Psychiatric Health, Digital Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 83 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 21 Oct 2022 (actual)
Primary completion: 31 Jan 2025 (actual)
Study completion: 31 Jan 2025 (actual)
First posted: 18 May 2022 (actual)
Results: Posted 10 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: Digital Behavioral Intervention

Arm	Type	Receives
SHEETS Arm 1	Active comparator	Behavioral: Garmin, Pattern Health AppParticipants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
SHEETS Arm 2	Experimental	Behavioral: Garmin, Pattern Health AppParticipants will receive sleep education-related content to support good sleep, like setting schedules.

Who may qualify

Ages: 12 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (7 listed)

ages 12-14 years
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

Key exclusion criteria (6 listed)

diagnosed sleep disorder
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Garmin, Pattern Health AppWearable sensors will deliver individualized feedback to participants according to their assigned intervention	Behavioural	SHEETS Arm 1, SHEETS Arm 2

Primary outcome

Change in Sleep Regularity Index (SRI)
Time frame: Baseline, 6 weeks, 3 months, 6 months
A measure of sleep regularity collected continuously over 7 days via actigraphy. The Sleep Regularity Index (SRI) ranges from 0-100 and is calculated as the proportion of pairs of time points 24 hours apart that have matching sleep/wake status. Higher scores indicate better sleep regularity.
Feasibility as Measured by Recruitment Percentage
Time frame: 6 months
The number of participants consenting (and assenting) divided by the number who were invited (i.e., passed the telephone prescreen) x 100 to produce a percentage.
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
Time frame: 6 weeks, 3 months, 6 months
Acceptability as the Average Adherence Rate
Time frame: 6 weeks
Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.

4 secondary outcomes

Change in Self-Reported Sleep Health
Time frame: Baseline, 6 weeks, 3 months, 6 months
Change in Adolescent Reported Psychiatric Health - Internalizing
Time frame: Baseline, 6 weeks, 3 months, 6 months
Change in Parent Reported Psychiatric Health - Internalizing
Time frame: Baseline, 6 weeks, 3 months, 6 months
Sleep Regularity Index (SRI) as Measured by Garmin
Time frame: 6 weeks

Results and safety

Results posted to the registry on 10 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Phase 1 Focus Groups - Adolescents	9	9
Phase 1 Focus Groups - Parents/Guardians	9	9
Phase 1 Focus Groups - Pediatricians	11	11
SHEETS Arm 1 - Adolescents	0	0
SHEETS Arm 2 - Adolescents	0	0

Primary outcome: Change in Sleep Regularity Index (SRI)

Time frame: Baseline, 6 weeks, 3 months, 6 months. Mean (Standard Deviation). Unit: units on a scale

Measure	SHEETS Arm 1 n = 25	SHEETS Arm 2 n = 25
Baseline	69.96 (2.07)	69.78 (2.07)
6 weeks	69.41 (2.10)	69.71 (2.07)
3 months	68.14 (2.28)	71.21 (2.49)
6 months	69.52 (3.03)	71.64 (3.19)

SHEETS Arm 1 vs SHEETS Arm 2: Beta estimate: 0.47, p = 0.87, Mixed Models Analysis

Population analysed: Phase 2 randomized trial participants who completed the study.

Primary outcome: Feasibility as Measured by Recruitment Percentage

Time frame: 6 months. Number. Unit: percentage of participants

Measure	All Invited Participants n = 98
Value	73.47

Population analysed: All invited participants prior to randomization.

Primary outcome: Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment

Time frame: 6 weeks, 3 months, 6 months. Count of participants. Unit: Participants

Measure	SHEETS Arm 1 n = 27	SHEETS Arm 2 n = 27
6 weeks	25	25
3 months	21	21
6 months	21	18

Population analysed: Phase 2 randomized trial participants.

Primary outcome: Acceptability as the Average Adherence Rate

Time frame: 6 weeks. Mean (Standard Deviation). Unit: percentage of sessions completed

Measure	SHEETS Arm 1 n = 25	SHEETS Arm 2 n = 25
Value	86.00 (19.83)	81.00 (27.02)

SHEETS Arm 1 vs SHEETS Arm 2: Mean Difference (Final Values): 0.84, p = 0.41, t-test, 2 sided

Population analysed: Phase 2 randomized trial participants who completed the study.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Phase 1 Focus Groups - Adolescents	0 of 0	0 of 0	0
SHEETS Arm 1 - Adolescents	0 of 27 (0%)	2 of 27 (7.4%)	0 of 27
SHEETS Arm 2 - Adolescents	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.

Related trials for Sleep

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jessica Lunsford-Avery, Ph.D. principal investigator

Duke University

Naomi Duke, M.D. principal investigator

Duke University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Garmin, Pattern Health App in people with Sleep and Psychiatric Health, run by Duke University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Sleep Regularity Index (SRI) (time frame: Baseline, 6 weeks, 3 months, 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05378373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.