Trial Outcomes & Findings for Sustainable Habits for Encouraging Even Teen Sleep (NCT NCT05378373)
NCT ID: NCT05378373
Last Updated: 2026-07-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
83 participants
Primary outcome timeframe
Baseline, 6 weeks, 3 months, 6 months
Results posted on
2026-07-10
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).
There are two phases to the study, and adolescent participants could participate in one or both phases. The first phase was for participation in focus groups in which adolescents, parents, and pediatricians provided feedback to refine both digital interventions for Phase 2 of this study. Phase 2 was the randomized controlled trial in which only adolescents were enrolled, and they completed one of two digital interventions.
Participant milestones
| Measure |
Phase 1 Focus Groups - Adolescents
The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study.
|
Phase 1 Focus Groups - Parents/Guardians
The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study.
|
Phase 1 Focus Groups - Pediatricians
The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study.
|
SHEETS Arm 1 - Adolescents
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2 - Adolescents
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|---|---|---|
|
Phase 1
STARTED
|
9
|
9
|
11
|
0
|
0
|
|
Phase 1
COMPLETED
|
9
|
9
|
11
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
0
|
0
|
27
|
27
|
|
Phase 2
COMPLETED
|
0
|
0
|
0
|
25
|
25
|
|
Phase 2
NOT COMPLETED
|
0
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Phase 1 Focus Groups - Adolescents
The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study.
|
Phase 1 Focus Groups - Parents/Guardians
The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study.
|
Phase 1 Focus Groups - Pediatricians
The first phase was for participation in focus groups in which participants provided feedback to refine both digital interventions for Phase 2 of this study.
|
SHEETS Arm 1 - Adolescents
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2 - Adolescents
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|---|---|---|
|
Phase 2
Lost to Follow-up
|
0
|
0
|
0
|
2
|
0
|
|
Phase 2
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Sustainable Habits for Encouraging Even Teen Sleep
Baseline characteristics by cohort
| Measure |
SHEETS Arm 1 - Adolescents
n=27 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2 - Adolescents
n=27 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.33 years
STANDARD_DEVIATION 0.70 • n=9 Participants
|
13.35 years
STANDARD_DEVIATION 0.92 • n=27 Participants
|
13.34 years
STANDARD_DEVIATION 0.81 • n=267 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
24 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
30 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
3 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=9 Participants
|
26 Participants
n=27 Participants
|
51 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
8 Participants
n=27 Participants
|
16 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
31 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=9 Participants
|
27 Participants
n=27 Participants
|
54 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 weeks, 3 months, 6 monthsPopulation: Phase 2 randomized trial participants who completed the study.
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.
Outcome measures
| Measure |
SHEETS Arm 1
n=25 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=25 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Change in Sleep Regularity Index (SRI)
3 months
|
68.14 units on a scale
Standard Deviation 2.28
|
71.21 units on a scale
Standard Deviation 2.49
|
|
Change in Sleep Regularity Index (SRI)
6 months
|
69.52 units on a scale
Standard Deviation 3.03
|
71.64 units on a scale
Standard Deviation 3.19
|
|
Change in Sleep Regularity Index (SRI)
Baseline
|
69.96 units on a scale
Standard Deviation 2.07
|
69.78 units on a scale
Standard Deviation 2.07
|
|
Change in Sleep Regularity Index (SRI)
6 weeks
|
69.41 units on a scale
Standard Deviation 2.10
|
69.71 units on a scale
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All invited participants prior to randomization.
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.
Outcome measures
| Measure |
SHEETS Arm 1
n=98 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Feasibility as Measured by Recruitment Percentage
|
73.47 percentage of participants
|
—
|
PRIMARY outcome
Timeframe: 6 weeks, 3 months, 6 monthsPopulation: Phase 2 randomized trial participants.
Outcome measures
| Measure |
SHEETS Arm 1
n=27 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=27 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
6 weeks
|
25 Participants
|
25 Participants
|
|
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
3 months
|
21 Participants
|
21 Participants
|
|
Feasibility as Measured by the Number of Participants Who Return for Each Sleep Regularity Assessment
6 months
|
21 Participants
|
18 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Phase 2 randomized trial participants who completed the study.
Number of Sessions Completed divided by Total Number of Sessions Offered, multiplied by 100.
Outcome measures
| Measure |
SHEETS Arm 1
n=25 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=25 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Acceptability as the Average Adherence Rate
|
86.00 percentage of sessions completed
Standard Deviation 19.83
|
81.00 percentage of sessions completed
Standard Deviation 27.02
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 3 months, 6 monthsPopulation: Phase 2 randomized trial participants who completed the study.
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.
Outcome measures
| Measure |
SHEETS Arm 1
n=25 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=25 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Change in Self-Reported Sleep Health
6 weeks
|
13.66 score on a scale
Standard Deviation 1.09
|
15.03 score on a scale
Standard Deviation 1.10
|
|
Change in Self-Reported Sleep Health
Baseline
|
13.98 score on a scale
Standard Deviation 1.09
|
16.25 score on a scale
Standard Deviation 1.10
|
|
Change in Self-Reported Sleep Health
3 months
|
13.18 score on a scale
Standard Deviation 1.16
|
15.0 score on a scale
Standard Deviation 1.21
|
|
Change in Self-Reported Sleep Health
6 months
|
14.20 score on a scale
Standard Deviation 1.38
|
13.71 score on a scale
Standard Deviation 1.35
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 3 months, 6 monthsPopulation: Phase 2 randomized trial participants who completed the study and had a sufficient number of items completed in order to score.
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.
Outcome measures
| Measure |
SHEETS Arm 1
n=25 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=23 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Change in Adolescent Reported Psychiatric Health - Internalizing
Baseline
|
49.61 T-score
Standard Deviation 1.83
|
48.91 T-score
Standard Deviation 1.88
|
|
Change in Adolescent Reported Psychiatric Health - Internalizing
6 weeks
|
45.13 T-score
Standard Deviation 1.88
|
46.45 T-score
Standard Deviation 2.07
|
|
Change in Adolescent Reported Psychiatric Health - Internalizing
3 months
|
46.60 T-score
Standard Deviation 2.44
|
44.09 T-score
Standard Deviation 2.26
|
|
Change in Adolescent Reported Psychiatric Health - Internalizing
6 months
|
47.09 T-score
Standard Deviation 2.82
|
43.72 T-score
Standard Deviation 2.84
|
SECONDARY outcome
Timeframe: Baseline, 6 weeks, 3 months, 6 monthsPopulation: Phase 2 randomized trial participants who completed the study and had a sufficient number of items completed in order to score.
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.
Outcome measures
| Measure |
SHEETS Arm 1
n=25 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=23 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Change in Parent Reported Psychiatric Health - Internalizing
3 months
|
46.58 T-score
Standard Deviation 2.53
|
48.20 T-score
Standard Deviation 2.19
|
|
Change in Parent Reported Psychiatric Health - Internalizing
6 months
|
50.75 T-score
Standard Deviation 2.53
|
50.13 T-score
Standard Deviation 2.54
|
|
Change in Parent Reported Psychiatric Health - Internalizing
Baseline
|
48.96 T-score
Standard Deviation 1.60
|
50.27 T-score
Standard Deviation 1.62
|
|
Change in Parent Reported Psychiatric Health - Internalizing
6 weeks
|
47.55 T-score
Standard Deviation 1.63
|
48.56 T-score
Standard Deviation 1.76
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Phase 2 randomized trial participants who completed the study and had sufficient Garmin data to calculate an SRI during the intervention phase.
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.
Outcome measures
| Measure |
SHEETS Arm 1
n=24 Participants
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2
n=22 Participants
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|
|
Sleep Regularity Index (SRI) as Measured by Garmin
|
78.11 units on a scale
Standard Deviation 10.63
|
80.49 units on a scale
Standard Deviation 7.80
|
Adverse Events
Phase 1 Focus Groups - Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
SHEETS Arm 1 - Adolescents
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
SHEETS Arm 2 - Adolescents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1 Focus Groups - Adolescents
The first phase was for participation in focus groups in which adolescents provided feedback to refine both digital interventions for Phase 2 of this study.
|
SHEETS Arm 1 - Adolescents
n=27 participants at risk
Participants will receive sleep education-related content on factors that impact sleep, like getting enough exercise.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
SHEETS Arm 2 - Adolescents
n=27 participants at risk
Participants will receive sleep education-related content to support good sleep, like setting schedules.
Garmin, Pattern Health App: Wearable sensors will deliver individualized feedback to participants according to their assigned intervention
|
|---|---|---|---|
|
Product Issues
Discomfort with Actigraph watch
|
—
0/0 • Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
|
3.7%
1/27 • Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
|
0.00%
0/27 • Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
|
|
Product Issues
Possible allergic reaction to Garmin watch
|
—
0/0 • Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
|
3.7%
1/27 • Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
|
0.00%
0/27 • Up to 1 week
Data not collected on Phase 1 Focus Groups participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place