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Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

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ClinicalTrials.gov Identifier: NCT01406691
Recruitment Status : Completed
First Posted : August 1, 2011
Last Update Posted : November 2, 2016
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., Stanford University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Delayed Sleep Phase Disorder Device: Flashes Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep
Study Start Date : December 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : September 2016

Arm Intervention/treatment
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
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
Placebo Comparator: Fake light
during three hours immediately prior to desired waketime, subjects will receive no light (light flash device will be disabled)
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



Primary Outcome Measures :
  1. Sleep quality [ Time Frame: weekly for four weeks ]
    Determined by questionnaire (Adolescent Sleep Wake Scale)


Secondary Outcome Measures :
  1. Mood [ Time Frame: at the begining and end of intervention (4 weeks) ]
    Center for Epidemiologic Studies Depression Scale for Children (depressive symptoms) SNAP-IV 26 (ADHD symptoms)



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Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01406691


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
Sponsors and Collaborators
Stanford University
VA Palo Alto Health Care System

Publications:
Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01406691     History of Changes
Other Study ID Numbers: kidflash
First Posted: August 1, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Keywords provided by Jamie M. Zeitzer, Ph.D., Stanford University:
sleep
delayed sleep phase disorder
circadian
teen
adolescent