Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Delayed Sleep Phase Disorder Clinical Trial

Official title:

Treating Sleep Disruption in Teens With Millisecond Light Exposure During Sleep

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01406691
• Other study ID #: kidflash
• Secondary ID: R01HD102344-01A1
• Status: Recruiting
• Phase: Phase 4
• Start date: December 2013
• Est. completion date: September 2028

Study information

• Verified date: March 2023
• Source: VA Palo Alto Health Care System
• Contact: Jamie Zeitzer, PhD
• Phone: 650-493-5000
• Email: jzeitzer[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Delayed Sleep Phase Disorder
• Disease

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep quality	Determined by questionnaire (Adolescent Sleep Wake Scale)	weekly for four weeks
Secondary	Mood	Center for Epidemiologic Studies Depression Scale for Children (depressive symptoms) SNAP-IV 26 (ADHD symptoms)	at the begining and end of intervention (4 weeks)