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Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

This study is not yet open for participant recruitment.
Verified June 2012 by VA Palo Alto Health Care System
Sponsor:
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., Stanford University
ClinicalTrials.gov Identifier:
NCT01406691
First received: July 29, 2011
Last updated: June 19, 2012
Last verified: June 2012
History of Changes

July 29, 2011
June 19, 2012
September 2012
June 2014   (final data collection date for primary outcome measure)
Sleep quality [ Time Frame: weekly for four weeks ] [ Designated as safety issue: No ]
Determined by questionnaire (Adolescent Sleep Wake Scale)
Same as current
Complete list of historical versions of study NCT01406691 on ClinicalTrials.gov Archive Site
Mood [ Time Frame: at the begining and end of intervention (4 weeks) ] [ Designated as safety issue: No ]
Center for Epidemiologic Studies Depression Scale for Children (depressive symptoms) SNAP-IV 26 (ADHD symptoms)
Same as current
 
 
 
Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)
Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep

Delayed Sleep Phase Disorder (DSPD) is a sleep disruption that commonly occurs in teens and manifests as a difficulty in waking up in the morning, going to sleep early enough at night, and daytime disturbances such as depression, fatigue, and restlessness. The purpose of this study is to determine if brief flashes of light, that are scheduled to occur during sleep, are effective in treating DSPD.
 
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Delayed Sleep Phase Disorder
Device: Flashes
three hours of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during three hours immediately prior to desired waketime
  • Experimental: Light
    three hours of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during three hours immediately prior to desired waketime
    Intervention: Device: Flashes
  • Placebo Comparator: Fake light
    during three hours immediately prior to desired waketime, subjects will receive no light (light flash device will be disabled)
    Intervention: Device: Flashes
Zeitzer JM, Ruby NF, Fisicaro RA, Heller HC. Response of the human circadian system to millisecond flashes of light. PLoS One. 2011;6(7):e22078. Epub 2011 Jul 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
57
September 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female
  • Full-time in high school
  • primary sleep complaint consistent with delayed sleep phase disorder

Exclusion Criteria:

  • sleep only in prone position
  • currently taking medications specifically for the treatment of a sleep disorder
Both
15 Years to 19 Years
No
Contact: Jamie Zeitzer, PhD 650-493-5000 ext 62410 jzeitzer@stanford.edu
United States
 
NCT01406691
kidflash
No
Jamie M. Zeitzer, Ph.D., Stanford University
Stanford University
 
 
VA Palo Alto Health Care System
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP