Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2022-07-01
2026-06-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Light + Cognitive Behavioral Therapy (CBT)
1 hour of light flashes (typical wake time - 75 min → typical wake time - 15 min) and cognitive behavioral therapy
Light
Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur every 20 s
CBT
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Sham light + CBT
1 hour of sham light flashes (one flash) and cognitive behavioral therapy
CBT
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Sham Light
Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur once
Interventions
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Light
Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur every 20 s
CBT
Cognitive behavioral therapy including psychoeducation, sleep hygiene, stimulus control, activity scheduling, motivational interviewing
Sham Light
Broad-spectrum white light flashes are \~4000 lux, 2 msec long, occur once
Eligibility Criteria
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Inclusion Criteria
2. Male or female
3. Willing and with a schedule permitting them to go to bed at an earlier time
4. Planning on sleeping at home in their bedroom for at least 75% of the study
Exclusion Criteria
2. Sleep only in the prone (face-down) position
14 Years
18 Years
ALL
Yes
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Stanford University
OTHER
Responsible Party
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Jamie M. Zeitzer, Ph.D.
Professor
Locations
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Stanford University
Stanford, California, United States
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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