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Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

This study has been completed.
Sponsor:
Collaborator:
VA Palo Alto Health Care System
Information provided by (Responsible Party):
Jamie M. Zeitzer, Ph.D., Stanford University
ClinicalTrials.gov Identifier:
NCT01406691
First received: July 29, 2011
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
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 Intervention Phase
Delayed Sleep Phase Disorder Device: Flashes Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep

Further study details as provided by Jamie M. Zeitzer, Ph.D., Stanford University:

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


Secondary Outcome Measures:
  • 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)


Enrollment: 104
Study Start Date: December 2013
Study Completion Date: September 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406691

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

Publications:
Responsible Party: Jamie M. Zeitzer, Ph.D., Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01406691     History of Changes
Other Study ID Numbers: kidflash
Study First Received: July 29, 2011
Last Updated: November 1, 2016

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

ClinicalTrials.gov processed this record on August 16, 2017