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?
Is light therapy safe for humans?
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.14567
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 OverviewThe 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
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)
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford UniversityPalo Alto, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
VA Palo Alto Health Care SystemCollaborator
References
Light Therapy With Scheduled Rise Times in Young Adults With Delayed Sleep Phase Disorder: Therapeutic Outcomes and Possible Predictors. [2018]Clinical trials with light therapy (LT) for delayed sleep phase disorder (DSPD) are sparse and little is known about factors that are favorable for improvements. In this study, LT with scheduled rise times was conducted at home for 14 days by 44 participants with DSPD aged 16-26 years. Primary outcomes were sleep onset and sleep offset. Potential predictors were demographic characteristics, chronotype, dim light melatonin onset, the number of days the LT lamp was used, the daily duration of LT, daytime sleepiness, anxiety, depression, worry, and rumination. Significant advances were observed in sleep onset and sleep offset from baseline to the end of treatment. The number of days of LT predicted earlier sleep onset and sleep offset.
Efficacy of enhanced evening light for advanced sleep phase syndrome. [2015]This study tested whether a newly designed enhanced evening light therapy was well tolerated and effective in relieving symptoms of Advanced, Sleep Phase Syndrome (ASPS). Participants with self-reported ASPS symptoms were 47 older adults (21 men and 26 women, age 60-86). After baseline, participants underwent 28 consecutive days of either dim or enhanced intensity light treatment for 2-3 hr in the evening. Enhanced evening light (approximately 265 lux) exposure was no more effective than a placebo dim light (approximately 2 lux) at alleviating advanced sleep phase as measured by actigraphically recorded sleep and urinary 6-sulphatoxymelatonin (aMT6s) excretion patterns. Participants receiving the enhanced light reported subjective benefit and a significant delay in sleep onset as compared to the placebo. Although compliance was good and the new enhanced evening light therapy design was well tolerated, the benefits were statistically equivocal.
Light therapy for the treatment of delayed sleep-wake phase disorder in adults: a systematic review. [2021]Delayed sleep-wake phase disorder (DSWPD) is characterized by sleep onset times, beyond the usual schedules and social conveniences, which potentially impacts on health as well as on school and professional performance. The most common treatment for DSWPD is the light administration (light therapy), through light devices, with or without behavioral instructions. Since there is no consensus in the literature about its efficacy and how it should be processed, this study aims to evaluate the light therapy effectiveness in the delayed sleep-wake phase disorder therapeutics. A systematic review was conducted using the MEDLINE/PubMed, Virtual Health Library Brazil, PsycINFO, Web of Science and Scopus databases along with a hand search until September 2020. The included studies presented participants diagnosed with insomnia or DSWPD, over 18-years old, treated only with morning light therapy, mentioning the light intensity (lux) used, and investigations with a control group. Studies reporting individuals with neurological or psychiatric disorders, shift-workers, or evaluating other sleep disorders were excluded. Among the 411 studies identified, five were selected for this review, resulting in a total sample of 140 individuals. Only two studies produced long-term results, showing that the benefits did not persist. In most studies, there were no statistically significant differences in the variables when comparing the intervention group and the control group. However, there were substantial clinical and laboratory advances in the sleep phase using light therapy when comparing phase advances for the same group concerning baseline values of sleep variables.
Bright-light mask treatment of delayed sleep phase syndrome. [2017]We treated delayed sleep phase syndrome (DSPS) with an illuminated mask that provides light through closed eyelids during sleep. Volunteers received either bright white light (2,700 lux, n = 28) or dim red light placebo (0.1 lux, n = 26) for 26 days at home. Mask lights were turned on (
Practice parameters for the use of light therapy in the treatment of sleep disorders. Standards of Practice Committee, American Academy of Sleep Medicine. [2019]These clinical guidelines were developed by the Standards of Practice Committee and reviewed and approved by the Board of Directors of the American Academy of Sleep Medicine. The guidelines provide recommendations for the practice of sleep medicine in North America regarding the use of light therapy for treatment of various sleep disorders. This paper is based on a series of articles in the Journal of Biological Rhythms and also includes evidence tables from an updated Medline review covering the period January 1994 to December 1997. Evidence is presented by grade and level. Recommendations are identified as standards, guidelines, or options. Recommendations are provided for delayed sleep phase syndrome (DSPS), advanced sleep phase syndrome (ASPS), non-24-hour sleep-wake syndrome, jet lag, shift work, dementia, and sleep complaints in the healthy elderly. Light therapy appears generally safe if used within recommended intensity and time limits. Light therapy can be useful in treatment of DSPS and ASPS. Benefits of light therapy are less clear and treatment is an option in jet lag, shift work, and non-24-hour sleep-wake syndrome in some blind patients.
Effects of phototherapy in patients with delayed sleep phase syndrome. [2015]Phototherapy was given to six patients with delayed sleep phase syndrome (DSPS). Polysomnography (PSG) and core body temperature were examined before and after phototherapy. Phototherapy was administered to each patient for 5 days, and this treatment not only advanced the delayed sleep phase but also delayed the time of minimum body temperature in all patients. On the PSG, decreases in total sleep time and amounts of stages 2 and REM were observed after phototherapy. These results suggest that phototherapy is effective even in the short term in advancing delays in sleep phase and time of minimum body temperature in DSPS patients.
Light mask 500 lux treatment for delayed sleep phase syndrome. [2019]1. Bright light exposure has been demonstrated as an effective treatment for circadian rhythm sleep disorders. Recent studies suggest that more moderate intensities of light might affect endogenous rhythms. A light mask treatment, using light applied through eyelids during sleep, was tested for Delayed Sleep Phase Syndrome. 2. The active light group (n = 5) received 500 lux light for 3 hours prior to awakening for 12 days. The placebo light group (n = 5) received 0.1 lux light with the same timing. Circadian rhythm phase was assessed from core body temperature and urinary 6-sulfatoxymelatonin measurements. The SIGH-SAD-SR mood scale was administered to assess mood. 3. There were slight trends toward a phase advance of the body temperature rhythm and a phase delay of the melatonin rhythm, and both groups reported anti-depressant benefits. However, no statistically significant effects of 500 lux light mask treatment were demonstrated compared with the placebo-light treatment. 4. More extensive studies will be required to clarify the factors of dose-response and phase-response.