Trial Outcomes & Findings for Sleep Treatment for Teens (NCT NCT05397353)
NCT ID: NCT05397353
Last Updated: 2026-07-08
Results Overview
Insomnia Severity Index (ISI), a 7-item self-report measure of insomnia symptom severity. Total scores are calculated by summing the seven items and range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). The ISI was assessed weekly throughout treatment; results presented here are baseline and end-of-study scores.
COMPLETED
NA
12 participants
Baseline and end of study (up to 10 weeks after baseline).
2026-07-08
Participant Flow
Participant milestones
| Measure |
Sleepio
Participants will receive the SleepioTM app
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sleep Treatment for Teens
Baseline characteristics by cohort
| Measure |
Sleepio
n=12 Participants
Participants will receive the SleepioTM app
|
|---|---|
|
Age, Categorical
<=18 years
|
12 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Baseline and end of study (up to 10 weeks after baseline).Population: All 12 enrolled participants completed the baseline assessment. Eight participants completed the end-of-study assessment and were included in the end-of-study summary statistics.
Insomnia Severity Index (ISI), a 7-item self-report measure of insomnia symptom severity. Total scores are calculated by summing the seven items and range from 0 to 28, with higher scores indicating greater insomnia severity (worse outcome). The ISI was assessed weekly throughout treatment; results presented here are baseline and end-of-study scores.
Outcome measures
| Measure |
Sleepio
n=12 Participants
Participants will receive the SleepioTM app
|
|---|---|
|
Insomnia Severity
Beginning of study (baseline)
|
18 Points on a scale
Standard Deviation 4.49
|
|
Insomnia Severity
End of study
|
14.13 Points on a scale
Standard Deviation 7.42
|
PRIMARY outcome
Timeframe: Baseline and end of study (up to 10 weeks after baseline).Population: Nine enrolled participants completed this measure in the baseline assessment. Seven of those participants completed this measure at the end-of-study assessment and were included in the end-of-study summary statistics.
Suicide Ideation Questionnaire Junior, a self-report measure of suicidal ideation. Total scores range from 0 to 90, with higher scores indicating greater suicidal ideation (worse outcome).
Outcome measures
| Measure |
Sleepio
n=9 Participants
Participants will receive the SleepioTM app
|
|---|---|
|
Suicidal Thoughts
Beginning of study (baseline)
|
36.56 Points on a scale
Standard Deviation 22.01
|
|
Suicidal Thoughts
End of study
|
17 Points on a scale
Standard Deviation 4.12
|
Adverse Events
Sleepio
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Evan Kleiman, Ph.D.
Rutgers, The State University of New Jersey
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place