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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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Sleep quality [ Time Frame: weekly for four weeks ] [ Designated as safety issue: No ]
    Determined by questionnaire (Adolescent Sleep Wake Scale)


Secondary Outcome Measures:
  • 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)


Estimated Enrollment: 57
Study Start Date: September 2012
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406691

Contacts
Contact: Jamie Zeitzer, PhD 650-493-5000 ext 62410 jzeitzer@stanford.edu

Locations
United States, California
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Principal Investigator: Jamie Zeitzer, PhD            
Sub-Investigator: Rafael Pelayo, MD            
Sponsors and Collaborators
Stanford University
  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: June 19, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
sleep
delayed sleep phase disorder
circadian
teen
adolescent

Additional relevant MeSH terms:
Sleep Disorders, Circadian Rhythm
Chronobiology Disorders
Nervous System Diseases
Dyssomnias
 Sleep Disorders
Occupational Diseases
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013