Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

NCT ID: NCT01406691

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2028-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Delayed Sleep Phase Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Light

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

Group Type EXPERIMENTAL

Flashes

Intervention Type 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

Fake light

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

Group Type PLACEBO_COMPARATOR

Flashes

Intervention Type 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

Interventions

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Flashes

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Jamie M. Zeitzer, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Stanford University

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jamie Zeitzer, PhD

Role: CONTACT

650-493-5000 ext. 62410

References

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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.

Reference Type BACKGROUND
PMID: 21760955 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25227334 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36552316 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35259981 (View on PubMed)

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.

Reference Type RESULT
PMID: 31553469 (View on PubMed)

Other Identifiers

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R01HD102344-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

kidflash

Identifier Type: -

Identifier Source: org_study_id

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