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Recruiting

NCT Number: NCT01406691

Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

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.

Recruiting

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University

Palo Alto, California, 94304, United States

Location status: Recruiting

Location contact

Jamie Zeitzer, PhD

PRINCIPAL_INVESTIGATOR

Rafael Pelayo, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flashes

Device

one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during the hour immediately prior to desired waketime

Primary outcomes

  1. Sleep quality

    Time frame: weekly for four weeks

    Determined by questionnaire (Adolescent Sleep Wake Scale)

Secondary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Jamie Zeitzer, PhD

CONTACT

[email protected]

650-493-5000 ext. 62410

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep

Important dates

Study start
2013
Primary completion
2028
Study completion
2028
First posted
Aug 1, 2011
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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