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Light Therapy

Light Therapy for Delayed Sleep Phase Syndrome

Phase 4
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Primary sleep complaint consistent with delayed sleep phase disorder
Be younger than 65 years old
Must not have
Currently taking medications specifically for the treatment of a sleep disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weekly for four weeks
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial tests if flashes of light can help teens with DSPD wake up in the morning, go to bed early, and reduce fatigue & depression.

Who is the study for?
This trial is for high school students who have trouble waking up early and falling asleep at night, often feeling depressed or restless during the day. It's specifically designed to help those with Delayed Sleep Phase Disorder (DSPD).
What is being tested?
The study is testing if brief light flashes during sleep can help treat DSPD. The goal is to see if this method can adjust the participants' sleep patterns to a more conventional timing.
What are the potential side effects?
Since the intervention involves light flashes, potential side effects may include temporary discomfort due to being woken up or disturbed during sleep by the flashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have trouble falling asleep at a conventional time.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am currently on medication for a sleep disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at the begining and end of intervention (4 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at the begining and end of intervention (4 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep quality
Secondary study objectives
Mood

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LightExperimental Treatment1 Intervention
one hour of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during hour immediately prior to desired waketime
Group II: Fake lightPlacebo Group1 Intervention
during hour immediately prior to desired waketime, subjects will receive one light flash (insufficient to cause phase shift)

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,474 Previous Clinical Trials
17,501,920 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,055 Previous Clinical Trials
2,731,874 Total Patients Enrolled
VA Palo Alto Health Care SystemFED
93 Previous Clinical Trials
58,132 Total Patients Enrolled

Media Library

Light Flashes (Light Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01406691 — Phase 4
Night owl syndrome Research Study Groups: Light, Fake light
Night owl syndrome Clinical Trial 2023: Light Flashes Highlights & Side Effects. Trial Name: NCT01406691 — Phase 4
Light Flashes (Light Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01406691 — Phase 4
~5 spots leftby Jun 2028
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