Shifting Sleep Timing in Teens
Passive Phototherapy to Improve Sleep in Teens
1 other identifier
interventional
160
1 country
1
Brief Summary
The goal of this clinical trial is to determine whether a combination of a novel lighting intervention and a behavioral intervention are able to increase total sleep time in adolescents. The main questions this trial aims to answer are whether this combination therapy is able to meaningfully increase total sleep time in adolescents, and do so over a sustained period of time, and whether such a changes is associated with concomitant changes in mood and cognitive performance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2022
CompletedFirst Submitted
Initial submission to the registry
March 29, 2023
CompletedFirst Posted
Study publicly available on registry
April 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 20, 2026
June 24, 2025
June 1, 2025
4 years
March 29, 2023
June 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Total sleep time
Average nightly total sleep time
20 weeks
Secondary Outcomes (2)
Melatonin timing
8 weeks
Mood
20 weeks
Study Arms (2)
Light + Cognitive Behavioral Therapy (CBT)
EXPERIMENTAL1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Sham light + CBT
ACTIVE COMPARATOR1 hour of sham light flashes (one flash) and cognitive behavioral therapy
Interventions
Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur every 20 s
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur once
Eligibility Criteria
You may qualify if:
- Aged 14-18 and a full-time student in grades 9-12
- Male or female
- Willing and with a schedule permitting them to go to bed at an earlier time
- Planning on sleeping at home in their bedroom for at least 75% of the study
You may not qualify if:
- Currently taking any medications (including over-the-counter medications, e.g., melatonin) specifically for the treatment of sleep disorders
- Sleep only in the prone (face-down) position
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Stanford University
Stanford, California, 94305, United States
Related Publications (1)
Keskinel D, Karan M, Kaplan KA, Mirchandaney R, Asarnow L, Zeitzer JM. Piloting a brief digital behavioral intervention for adolescent sleep. Sleep Sci Pract. 2025;9(1):34. doi: 10.1186/s41606-025-00157-4. Epub 2025 Oct 31.
PMID: 41180604DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 29, 2023
First Posted
April 11, 2023
Study Start
July 1, 2022
Primary Completion (Estimated)
June 20, 2026
Study Completion (Estimated)
June 20, 2026
Last Updated
June 24, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
Deidentified data will be made freely available on Dryad.com. Study protocol, analysis plan, consent form (unsigned), and analytic code will be made available upon request.