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CompletedNCT05378373SHEETSUpdated Jul 10, 2026Results posted

Sustainable Habits for Encouraging Even Teen Sleep

An interventional study of Garmin, Pattern Health App in Sleep and Psychiatric Health, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 12 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Duke University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
12 Years to 14 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Sleep
  • Psychiatric Health

Keywords

  • Adolescents
  • Sleep
  • Psychiatric Health
  • Digital Intervention
03

In context

Lead sponsor

Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.

Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
83 participants (actual)

Study arms

  • Active comparator
    SHEETS Arm 1

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

    Behavioral: Garmin, Pattern Health App

  • Experimental
    SHEETS Arm 2

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

    Behavioral: Garmin, Pattern Health App

Interventions

  • BehavioralGarmin, Pattern Health App

    Wearable sensors will deliver individualized feedback to participants according to their assigned intervention

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 6 weeks, 3 months, 6 months

  2. 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.

    Time frame: 6 months

  3. Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment

    Time frame: 6 weeks, 3 months, 6 months

  4. Acceptability as the Average Adherence Rate

    Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.

    Time frame: 6 weeks

Secondary outcomes

  1. 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.

    Time frame: Baseline, 6 weeks, 3 months, 6 months

  2. 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.

    Time frame: Baseline, 6 weeks, 3 months, 6 months

  3. 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.

    Time frame: Baseline, 6 weeks, 3 months, 6 months

  4. 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.

    Time frame: 6 weeks

07

Results

Posted Jul 10, 2026

Participant flow

Recruitment occurred during well-check visits in pediatric primary care clinics, via digital fliers through schools and social media, and by contacting parents or guardians of potentially eligible adolescents using contact information in the electronic health record (EHR).

Phase 1
Participant flow — Phase 1
MilestonePhase 1 Focus Groups - AdolescentsPhase 1 Focus Groups - Parents/GuardiansPhase 1 Focus Groups - PediatriciansSHEETS Arm 1 - AdolescentsSHEETS Arm 2 - Adolescents
Started991100
Completed991100
Not completed00000
Phase 2
Participant flow — Phase 2
MilestonePhase 1 Focus Groups - AdolescentsPhase 1 Focus Groups - Parents/GuardiansPhase 1 Focus Groups - PediatriciansSHEETS Arm 1 - AdolescentsSHEETS Arm 2 - Adolescents
Started0002727
Completed0002525
Not completed00022
Withdrew: Lost to follow-up00020
Withdrew: Withdrawal by subject00002

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, 6 weeks, 3 months, 6 months
Reported as:
Mean · units on a scale
Change in Sleep Regularity Index (SRI)
units on a scaleSHEETS Arm 1SHEETS Arm 2
Baseline69.96 ± 2.0769.78 ± 2.07
6 weeks69.41 ± 2.1069.71 ± 2.07
3 months68.14 ± 2.2871.21 ± 2.49
6 months69.52 ± 3.0371.64 ± 3.19
Statistical analysis
  • SHEETS Arm 1 vs SHEETS Arm 2 · Mixed Models Analysis · p = 0.87 (Group is entered as a between-subjects factor and Visit is entered as a repeated factor with 2 levels (baseline compared with 6 weeks).) · Beta estimate: 0.47Estimation parameter is beta estimate for group by visit interaction term.
PrimaryFeasibility 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.

Time frame:
6 months
Reported as:
Number · percentage of participants
Feasibility as Measured by Recruitment Percentage
percentage of participantsAll Invited Participants
Feasibility as Measured by Recruitment Percentage73.47
PrimaryFeasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
Time frame:
6 weeks, 3 months, 6 months
Reported as:
Count of participants · Participants
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
ParticipantsSHEETS Arm 1SHEETS Arm 2
6 weeks2525
3 months2121
6 months2118
PrimaryAcceptability as the Average Adherence Rate

Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.

Time frame:
6 weeks
Reported as:
Mean · percentage of sessions completed
Acceptability as the Average Adherence Rate
percentage of sessions completedSHEETS Arm 1SHEETS Arm 2
Acceptability as the Average Adherence Rate86.00 ± 19.8381.00 ± 27.02
Statistical analysis
  • SHEETS Arm 1 vs SHEETS Arm 2 · t-test, 2 sided · p = 0.41 · Mean difference (final values): 0.84
SecondaryChange 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.

Time frame:
Baseline, 6 weeks, 3 months, 6 months
Reported as:
Mean · score on a scale
Change in Self-Reported Sleep Health
score on a scaleSHEETS Arm 1SHEETS Arm 2
Baseline13.98 ± 1.0916.25 ± 1.10
6 weeks13.66 ± 1.0915.03 ± 1.10
3 months13.18 ± 1.1615.0 ± 1.21
6 months14.20 ± 1.3813.71 ± 1.35
Statistical analysis
  • SHEETS Arm 1 vs SHEETS Arm 2 · Mixed Models Analysis · p = 0.47 (Group is entered as a between-subjects factor and Visit is entered as a repeated factor with 2 levels (baseline compared with 6 weeks).) · Beta estimate: -0.89Estimation parameter is beta estimate for group by visit interaction term.
SecondaryChange 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.

Time frame:
Baseline, 6 weeks, 3 months, 6 months
Reported as:
Mean · T-score
Change in Adolescent Reported Psychiatric Health - Internalizing
T-scoreSHEETS Arm 1SHEETS Arm 2
Baseline49.61 ± 1.8348.91 ± 1.88
6 weeks45.13 ± 1.8846.45 ± 2.07
3 months46.60 ± 2.4444.09 ± 2.26
6 months47.09 ± 2.8243.72 ± 2.84
Statistical analysis
  • SHEETS Arm 1 vs SHEETS Arm 2 · Mixed Models Analysis · p = 0.40 (Group is entered as a between-subjects factor and Visit is entered as a repeated factor with 2 levels (baseline compared with 6 weeks).) · Beta estimate: 2.02Estimation parameter is beta estimate for group by visit interaction term.
SecondaryChange 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.

Time frame:
Baseline, 6 weeks, 3 months, 6 months
Reported as:
Mean · T-score
Change in Parent Reported Psychiatric Health - Internalizing
T-scoreSHEETS Arm 1SHEETS Arm 2
Baseline48.96 ± 1.6050.27 ± 1.62
6 weeks47.55 ± 1.6348.56 ± 1.76
3 months46.58 ± 2.5348.20 ± 2.19
6 months50.75 ± 2.5350.13 ± 2.54
Statistical analysis
  • SHEETS Arm 1 vs SHEETS Arm 2 · Mixed Models Analysis · p = 0.89 (Group is entered as a between-subjects factor and Visit is entered as a repeated factor with 2 levels (baseline compared with 6 weeks).) · Beta estimate: -0.31Estimation parameter is beta estimate for group by visit interaction term.
SecondarySleep 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.

Time frame:
6 weeks
Reported as:
Mean · units on a scale
Sleep Regularity Index (SRI) as Measured by Garmin
units on a scaleSHEETS Arm 1SHEETS Arm 2
Sleep Regularity Index (SRI) as Measured by Garmin78.11 ± 10.6380.49 ± 7.80
Statistical analysis
  • SHEETS Arm 1 vs SHEETS Arm 2 · t-test, 2 sided · p = 0.39

Adverse events

Collected over Up to 1 week. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phase 1 Focus Groups - Adolescents———
SHEETS Arm 1 - Adolescents0/27 (0%)0/27 (0%)2/27 (7.4%)
SHEETS Arm 2 - Adolescents0/27 (0%)0/27 (0%)0/27 (0%)
Most frequent other events
Most frequent other events
EventPhase 1 Focus Groups - AdolescentsSHEETS Arm 1 - AdolescentsSHEETS Arm 2 - Adolescents
Discomfort with Actigraph watchProduct Issues—1/270/27
Possible allergic reaction to Garmin watchProduct Issues—1/270/27

Baseline characteristics

Only adolescents enrolled in Phase 2 (the randomized clinical trial) participated in baseline analysis. Phase 1 (Focus Groups) concluded prior to Phase 2 (the randomized clinical trial). Baseline data was not collected on Phase 1 Focus Groups participants.

Age, Continuous
Age, Continuous(years)SHEETS Arm 1 - AdolescentsSHEETS Arm 2 - AdolescentsTotal
Mean13.33 ± 0.7013.35 ± 0.9213.34 ± 0.81
Sex: Female, Male
Sex: Female, Male(Participants)SHEETS Arm 1 - AdolescentsSHEETS Arm 2 - AdolescentsTotal
Female131124
Male141630
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)SHEETS Arm 1 - AdolescentsSHEETS Arm 2 - AdolescentsTotal
Hispanic or Latino213
Not Hispanic or Latino252651
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)SHEETS Arm 1 - AdolescentsSHEETS Arm 2 - AdolescentsTotal
American Indian or Alaska Native101
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American8816
White151631
More than one race325
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)SHEETS Arm 1 - AdolescentsSHEETS Arm 2 - AdolescentsTotal
United States272754
08

Study locations

1 site
  • Duke Children's Primary Care North Durham
    Durham, North Carolina 27704, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Jun 25, 2025
  • Informed consent form · Oct 16, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All of the individual participant data collected during the trial (including data dictionaries) will be available for this study after deidentification.

Supporting information: Study protocol

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05378373
Lead sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
May 18, 2022
Start date
Oct 21, 2022
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025
Results posted
Jul 10, 2026
Last update
Jul 10, 2026

Study contacts

Jessica Lunsford-Avery, Ph.D.
principal investigator · Duke University
Naomi Duke, M.D.
principal investigator · Duke University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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