Light Therapy for Delayed Sleep Phase Syndrome

Overseen By Jamie Zeitzer, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Stanford University

Must not be taking: Sleep disorder medications

Disqualifiers: Prone sleeping position

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether brief flashes of light during sleep can help treat Delayed Sleep Phase Disorder (DSPD), a condition where individuals struggle to fall asleep and wake up at typical hours, leading to issues like depression and fatigue. Participants will receive either a sequence of light flashes (a form of light therapy) or a single, less intense flash for comparison. The trial seeks high school students who have trouble with their sleep schedules, consistent with DSPD. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand how it benefits more patients.

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 is the safety track record for light flashes therapy?

Research shows that light therapy is usually easy for people to handle. Studies have found that bright light therapy, including the light flashes used in this trial, is safe and effective for treating sleep problems such as Delayed Sleep Phase Disorder (DSPD). Most people do not experience serious side effects.

Some might feel mild discomfort, like eye strain or headaches, but these are uncommon. Overall, the treatment is considered safe, especially since this trial is in a later stage, indicating strong evidence of its safety. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using light flashes for Delayed Sleep Phase Syndrome because it offers a unique and non-invasive approach to shifting sleep patterns. Unlike standard treatments such as melatonin supplements or behavioral therapy, this method uses a series of timed light flashes, which are designed to reset the body's internal clock more precisely. This technique is particularly appealing because it could provide a quicker and potentially more effective way to adjust sleep cycles without the need for medication, making it an attractive option for those seeking a natural remedy.

What evidence suggests that light flashes are effective for treating Delayed Sleep Phase Disorder?

Studies have shown that light therapy can effectively assist individuals with Delayed Sleep Phase Disorder (DSPD). Bright light resets the body's internal clock, facilitating easier sleep onset and wakefulness at desired times. Research indicates that bright light therapy can accelerate sleep onset, improve sleep schedules, and enhance daytime alertness. Participants have reported better sleep patterns and reduced daytime fatigue and restlessness. Light therapy is already recognized for addressing body clock issues, such as DSPD, in both teens and adults. In this trial, participants will receive either a sequence of light flashes or a placebo comparator with a single light flash. This approach suggests that using light flashes during sleep might effectively treat DSPD. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Light Flashes

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.

How Is the Trial Designed?

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 United States, European Union, Canada for the following indications:

Approved in United States as Phototherapy for:

• Delayed Sleep Phase Disorder (DSPD)
• Advanced Sleep-Wake Phase Disorder
• Free-Running or Non-24-Hour Sleep-Wake Rhythm Disorder
• Jet Lag

Approved in European Union as Bright Light Therapy for:

• Delayed Sleep Phase Disorder (DSPD)
• Seasonal Affective Disorder (SAD)
• Circadian Rhythm Sleep Disorders

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+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 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]

Citations

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This study provides evidence regarding the effect of light therapy in reducing sleepiness and shifting circadian phase in shift workers.

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Objective: To evaluate cognitive-behavior therapy plus bright light therapy (CBT plus BLT) for adolescents diagnosed with delayed sleep phase disorder (DSPD).

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A pulse of morning bright light generates a circadian phase advance, which is thought to correct the discordance between sleep and circadian phase, and thereby ...

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sciencedirect.com

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Delayed Sleep Phase Syndrome (DSPS) in Adolescents

Delayed Sleep Phase Syndrome explained: get expert insight on DSPS in adolescents, treatment plans, and how light therapy aids recovery.