Light Therapy for Delayed Sleep Phase Syndrome

Recruiting in Palo Alto (17 mi)

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Stanford University

Must not be taking: Sleep disorder medications

Disqualifiers: Prone sleeping position

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking medications specifically for the treatment of a sleep disorder.

What data supports the effectiveness of light therapy for Delayed Sleep Phase Syndrome?

Research shows that light therapy can help people with Delayed Sleep Phase Syndrome by shifting their sleep times earlier. Studies found significant improvements in sleep onset and offset times, especially when the therapy was used consistently over several days. ^{1 2 3 4 5}

Is light therapy safe for humans?

Light therapy, when used within recommended intensity and time limits, is generally considered safe for humans. It has been well tolerated in studies, with no significant safety concerns reported. ^{2 3 4 5 6}

How does light therapy differ from other treatments for delayed sleep phase syndrome?

Light therapy for delayed sleep phase syndrome is unique because it uses scheduled exposure to bright light to adjust the body's internal clock, helping to advance sleep onset and offset times. Unlike medications, it is a non-drug treatment that can be administered at home, and it works by influencing the body's natural circadian rhythms. ^{1 4 5 6 7}

Research Team

Eligibility Criteria

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).

Inclusion Criteria

I am a full-time high school student.

I have trouble falling asleep at a conventional time.

I am either male or female.

Exclusion Criteria

Sleep only in prone position

I am currently on medication for a sleep disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive light flashes during sleep to treat DSPD

4 weeks

Weekly assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Light Flashes (Light Therapy)

Trial Overview 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.

Participant Groups

Group I: Light Experimental Treatment 1 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 light Placebo Group 1 Intervention

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

Light Flashes is already approved in Canada for the following indications:

Approved in Canada as Light Therapy for:

• Delayed Sleep Phase Disorder (DSPD)
• Advanced Sleep-Wake Phase Disorder
• Insomnia

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

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

Collaborator

Trials

2,103

Recruited

2,760,000+

Dr. Diana W. Bianchi

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

Chief Executive Officer since 2016

MD from Stanford University

Dr. Alison Cernich

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

Chief Medical Officer since 2020

PhD in Clinical Psychology from University of Maryland

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Jean J. Gurga

VA Palo Alto Health Care System

Medical Center Director since 2023

Master's degree in Occupational Therapy from Tufts University, Bachelor's degree in Business Economics from Mills College

Rina N. Shah

VA Palo Alto Health Care System

Chief of Staff

MD, FACP

Findings from Research

In a 14-day home study involving 44 participants aged 16-26 with delayed sleep phase disorder, light therapy significantly improved both sleep onset and sleep offset times.

The effectiveness of light therapy was positively influenced by the number of days the therapy lamp was used, indicating that consistent use is key for better sleep outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light Therapy With Scheduled Rise Times in Young Adults With Delayed Sleep Phase Disorder: Therapeutic Outcomes and Possible Predictors. Danielsson, K., Jansson-Fröjmark, M., Broman, JE., et al.[2018]

In a study involving 47 older adults with Advanced Sleep Phase Syndrome, enhanced evening light therapy (approximately 265 lux) was found to be no more effective than a placebo dim light (approximately 2 lux) in objectively improving sleep patterns.

Despite the lack of significant objective benefits, participants receiving the enhanced light reported subjective improvements and a notable delay in sleep onset, indicating potential personal benefits even if not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced evening light for advanced sleep phase syndrome. Palmer, CR., Kripke, DF., Savage, HC., et al.[2015]

Light therapy is a common treatment for Delayed Sleep-Wake Phase Disorder (DSWPD), but a systematic review of five studies involving 140 participants found that it may not produce statistically significant long-term benefits compared to control groups.

While light therapy showed some clinical improvements in sleep phase timing when compared to baseline values, the overall effectiveness and persistence of these benefits remain uncertain, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy for the treatment of delayed sleep-wake phase disorder in adults: a systematic review. Gomes, JN., Dias, C., Brito, RS., et al.[2021]

A study involving 54 volunteers with delayed sleep phase syndrome (DSPS) showed that using a bright light mask significantly advanced their circadian rhythms and sleep onset times compared to a dim light placebo.

Participants with more severe circadian delays experienced the most benefit from the bright light treatment, reporting it as more effective, and the treatment was well tolerated with minimal sleep disturbance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright-light mask treatment of delayed sleep phase syndrome. Cole, RJ., Smith, JS., Alcalá, YC., et al.[2017]

Light therapy is generally safe and effective for treating delayed sleep phase syndrome (DSPS) and advanced sleep phase syndrome (ASPS), according to clinical guidelines developed by the American Academy of Sleep Medicine.

While light therapy shows potential benefits for conditions like jet lag, shift work, and non-24-hour sleep-wake syndrome, its efficacy in these areas is less clear, particularly for some blind patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practice parameters for the use of light therapy in the treatment of sleep disorders. Standards of Practice Committee, American Academy of Sleep Medicine. Chesson, AL., Littner, M., Davila, D., et al.[2019]

Phototherapy effectively advanced the sleep phase and delayed the minimum body temperature in all six patients with delayed sleep phase syndrome (DSPS) after just 5 days of treatment.

Polysomnography results indicated a decrease in total sleep time and reductions in sleep stages 2 and REM, suggesting that while phototherapy is effective in shifting sleep patterns, it may also alter sleep architecture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of phototherapy in patients with delayed sleep phase syndrome. Watanabe, T., Kajimura, N., Kato, M., et al.[2015]

A light mask treatment using 500 lux light for 3 hours prior to awakening was tested on 10 participants with Delayed Sleep Phase Syndrome, but did not show statistically significant effects compared to a placebo light treatment.

Both groups reported mood improvements, indicating potential antidepressant benefits from light exposure, but further research is needed to explore the effects of different light intensities and durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light mask 500 lux treatment for delayed sleep phase syndrome. Ando, K., Kripke, DF., Cole, RJ., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Light Therapy With Scheduled Rise Times in Young Adults With Delayed Sleep Phase Disorder: Therapeutic Outcomes and Possible Predictors. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of enhanced evening light for advanced sleep phase syndrome. [2015]

3. Germany pubmed.ncbi.nlm.nih.gov

Light therapy for the treatment of delayed sleep-wake phase disorder in adults: a systematic review. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Bright-light mask treatment of delayed sleep phase syndrome. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

Practice parameters for the use of light therapy in the treatment of sleep disorders. Standards of Practice Committee, American Academy of Sleep Medicine. [2019]

6. Australia pubmed.ncbi.nlm.nih.gov

Effects of phototherapy in patients with delayed sleep phase syndrome. [2015]

7. England pubmed.ncbi.nlm.nih.gov

Light mask 500 lux treatment for delayed sleep phase syndrome. [2019]