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Recruiting NCT05808179

Shifting Sleep Timing in Teens

No phase Interventional Sleep Insufficiency Sleep Adolescent Behavior

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Light, CBT, Sham Light.
Who it may be relevant to
Registry conditions: Sleep Insufficiency, Sleep, Adolescent Behavior. Basic parameters: 14 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Passive Phototherapy to Improve Sleep in Teens

Overview

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.

Interventions

  • Device Light
    Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur every 20 s
  • Behavioral CBT
    Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
  • Device Sham Light
    Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur once

Primary outcome measures

  • Total sleep time [Time frame: 20 weeks]
Secondary outcome measures (2)
  • Melatonin timing [Time frame: 8 weeks]
  • Mood [Time frame: 20 weeks]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Stanford University — Stanford

Publications

  • 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 41180604

Identifiers

NCT: NCT05808179 · 1R01HD102344

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗