Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Stanford University

Status and phase: Enrolling; Phase 4

Conditions: Delayed Sleep Phase Disorder

Treatments: Device: Flashes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01406691

kidflash

R01HD102344-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 15 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Light

Experimental group

Description:

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

Treatment:

Device: Flashes

Fake light

Placebo Comparator group

Description:

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

Treatment:

Device: Flashes