NCT01406691

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
29mo left

Started Dec 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2013Sep 2028

First Submitted

Initial submission to the registry

July 29, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
14.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2028

Last Updated

March 24, 2023

Status Verified

March 1, 2023

Enrollment Period

14.5 years

First QC Date

July 29, 2011

Last Update Submit

March 22, 2023

Conditions

Delayed Sleep Phase Disorder

Keywords

sleepdelayed sleep phase disordercircadianteenadolescent

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

    Determined by questionnaire (Adolescent Sleep Wake Scale)

    weekly for four weeks

Secondary Outcomes (1)

  • Mood

    at the begining and end of intervention (4 weeks)

Study Arms (2)

Light

EXPERIMENTAL

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

Device: Flashes

Fake light

PLACEBO COMPARATOR

during hour immediately prior to desired waketime, subjects will receive one light flash (insufficient to cause phase shift)

Device: Flashes

Interventions

FlashesDEVICE

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

Fake lightLight

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • sleep only in prone position
  • currently taking medications specifically for the treatment of a sleep disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

Related Publications (5)

  • 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. doi: 10.1371/journal.pone.0022078. Epub 2011 Jul 8.

    PMID: 21760955BACKGROUND

  • Zeitzer JM, Fisicaro RA, Ruby NF, Heller HC. Millisecond flashes of light phase delay the human circadian clock during sleep. J Biol Rhythms. 2014 Oct;29(5):370-6. doi: 10.1177/0748730414546532. Epub 2014 Sep 16.

    PMID: 25227334BACKGROUND

  • Joyce DS, Spitschan M, Zeitzer JM. Optimizing Light Flash Sequence Duration to Shift Human Circadian Phase. Biology (Basel). 2022 Dec 13;11(12):1807. doi: 10.3390/biology11121807.

    PMID: 36552316BACKGROUND

  • Joyce DS, Spitschan M, Zeitzer JM. Duration invariance and intensity dependence of the human circadian system phase shifting response to brief light flashes. Proc Biol Sci. 2022 Mar 9;289(1970):20211943. doi: 10.1098/rspb.2021.1943. Epub 2022 Mar 9.

    PMID: 35259981BACKGROUND

  • Kaplan KA, Mashash M, Williams R, Batchelder H, Starr-Glass L, Zeitzer JM. Effect of Light Flashes vs Sham Therapy During Sleep With Adjunct Cognitive Behavioral Therapy on Sleep Quality Among Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2019 Sep 4;2(9):e1911944. doi: 10.1001/jamanetworkopen.2019.11944.

    PMID: 31553469RESULT

Central Study Contacts

Jamie Zeitzer, PhD

CONTACT

650-493-5000jzeitzer@stanford.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 29, 2011

First Posted

August 1, 2011

Study Start

December 1, 2013

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

September 1, 2028

Last Updated

March 24, 2023

Record last verified: 2023-03

Locations

US(1)