Phototherapy for Shift Work Sleep Disorder

(SHIFT Trial)

Overseen By Cynthia Fellman-Couture, RN, BSN, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Must not be taking: CNS medications

Disqualifiers: CNS disorders, Sleep disorders, Unstable conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 2 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effectiveness of a personalized light exposure schedule for Shift Work Disorder (SWD) in night shift workers compared to a non-personalized light exposure schedule.

Do I need to stop taking my current medications for the trial?

The trial excludes participants using medications that impact central nervous system functioning, so you may need to stop taking such medications.

What data supports the idea that Phototherapy for Shift Work Sleep Disorder is an effective treatment?

The available research shows that phototherapy can effectively reduce sleepiness and adjust the sleep schedule for shift workers. A meta-analysis found that medium-intensity light therapy for a short time at night helps reduce sleepiness, while high-intensity light therapy helps shift the sleep schedule to better match the work hours. This suggests that phototherapy can help shift workers feel more awake and align their sleep patterns with their work schedule. ^{1 2 3 4 5}

What safety data exists for phototherapy in treating sleep disorders?

Phototherapy, also known as light therapy, has been studied for its safety and efficacy in treating circadian rhythm sleep disorders. Safety concerns primarily involve potential ocular risks, as light can affect retinal structure and physiology. Recommendations include using lamps that avoid harmful spectral emissions, standardized therapy fixtures, and monitoring by ophthalmologists for patients with eye conditions. For those with healthy eyes, optometrist supervision is advised for extended treatments. Phototherapy should be avoided in patients with retinal disorders, and consultation with an ophthalmologist is recommended. ^{3 4 6 7 8}

Is phototherapy a promising treatment for Shift Work Sleep Disorder?

Yes, phototherapy is a promising treatment for Shift Work Sleep Disorder. It helps reduce sleepiness and adjust the body's internal clock, making it easier for shift workers to stay alert and sleep better. ^{3 4 5 9 10}

Eligibility Criteria

This trial is for night shift workers who've been on this schedule for at least 6 months and have Shift Work Disorder based on ICSD-3 criteria. They must work a minimum of two night shifts per week, starting between 6 PM and 2 AM, lasting from 8 to 12 hours. Pregnant individuals, those with other sleep disorders or unstable major medical conditions, heavy tobacco users, and people using certain drugs are excluded.

Inclusion Criteria

I have been diagnosed with Shift Work Disorder.

Participants must have maintained this night shift schedule for at least 6 months

Participants must have night shifts starting between 18:00 and 02:00 and lasting 8 to 12 hours

Exclusion Criteria

Dependence on alcohol (≥ 4 beverages a day)

Heavy tobacco use (≥ 10 cigarettes per day)

I have been diagnosed with a sleep disorder before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Participants wear an Apple Watch for data collection

Pre-treatment Assessment

27-hour laboratory visit for pre-treatment assessment of DLMO with hourly saliva melatonin samples

27 hours

1 in-lab visit

Treatment

Participants follow light exposure recommendations from the SHIFT mobile application for two weeks

2 weeks

Follow-up

Participants are monitored for insomnia and daytime sleepiness post-treatment

1 week

Treatment Details

Interventions

• Phototherapy

Trial Overview The study is testing the effectiveness of personalized light exposure schedules versus non-personalized ones in treating Shift Work Disorder among night shift workers. It aims to determine if tailoring light exposure can improve sleep quality and overall well-being.

Participant Groups

Group I: Personalized light condition Experimental Treatment 1 Intervention

Participants will receive light exposure recommendations from the SHIFT mobile application based on their activity levels. Participants will follow these recommendations over the course of two weeks.

Group II: Non-personalized light condition Active Control 1 Intervention

Participants will receive light exposure recommendations from the SHIFT mobile application based on their habitual sleep schedule. Participants will follow these recommendations over the course of two weeks.

Phototherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder

Approved in United States as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder
• Shift Work Disorder

Approved in Canada as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder

Approved in Japan as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice

Approved in China as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice

Approved in Switzerland as Phototherapy for:

• Psoriasis
• Eczema
• Vitiligo
• Neonatal Jaundice
• Seasonal Affective Disorder

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Findings from Research

Phototherapy at 8,000 Lux for 1.5 hours over 5 days effectively restored sleep-wake patterns and alleviated delirium symptoms in a patient who did not respond to haloperidol, suggesting a potential alternative treatment for delirium.

The case highlights the possible link between metabolic changes due to sepsis and delirium, indicating that phototherapy may help in normalizing circadian rhythms disrupted by such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of delirium with phototherapy: a case report. Fortuyn, HD., Schoemaker, J.[2020]

A 17-year-old male with non-24 hour sleep-wake syndrome showed immediate improvement in his sleep-wake and body temperature rhythms after receiving phototherapy during hospitalization.

Polysomnography results indicated that phototherapy reduced total sleep time and stages 1 and 2 of sleep while increasing deeper sleep stages (3+4), suggesting that phototherapy can effectively normalize sleep patterns in this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case of a non-24 h sleep-wake syndrome patient improved by phototherapy. Watanabe, T., Kajimura, N., Kato, M., et al.[2004]

Phototherapy is an effective treatment for various circadian sleep-wake disorders, including advanced and delayed sleep-wake phase disorders, non-24-hour sleep-wake rhythm disorder, jet lag, and night-shift work sleep-wake disorders.

The success of phototherapy relies on specific light characteristics such as intensity, duration, timing, and wavelength, but it should be avoided in patients with retinal disorders, necessitating consultation with an ophthalmologist.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating circadian sleep-wake disorders by light]. Leger, D., Duforez, F., Gronfier, C.[2019]

Light therapy is an effective, evidence-based treatment for Seasonal Affective Disorder, influencing circadian rhythms that affect sleep, mood, and cognition, based on 40 years of clinical trials.

For optimal results, light therapy should use devices that provide 10,000 lux of white light for 30-60 minutes in the early morning, with ongoing monitoring to adjust treatment as needed and manage any side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

Light therapy is effective in reducing sleepiness and shifting circadian phases in shift workers, with a meta-analysis of 21 studies showing small to medium effects on sleepiness and large effects on circadian phase shift.

Medium-intensity light therapy for shorter durations is best for reducing nighttime sleepiness, while higher-intensity light therapy is more effective for inducing circadian phase shifts, although the optimal treatment duration is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response effects of light therapy on sleepiness and circadian phase shift in shift workers: a meta-analysis and moderator analysis. Lam, C., Chung, MH.[2021]

In a study involving 30 patients with chronic fatigue syndrome (CFS), neither melatonin nor bright-light phototherapy showed significant improvements in CFS symptoms or overall health after 12 weeks of treatment.

The only notable change was a slight advance in body temperature rhythm with phototherapy, but this did not translate to symptom relief, suggesting that these treatments may be ineffective for CFS and should be used cautiously until proven beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy of circadian rhythm disorders in chronic fatigue syndrome: no symptomatic improvement with melatonin or phototherapy. Williams, G., Waterhouse, J., Mugarza, J., et al.[2019]

Bright light therapy is effective for treating seasonal affective disorder (SAD) and has potential applications for other conditions like circadian sleep phase disorders and jet lag, but the safety of different light sources is a concern.

The study analyzed various light therapy fixtures, revealing that many emit unknown spectral emissions that could cause ocular damage, leading to recommendations for safer lamp choices and monitoring for patients undergoing prolonged treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy in focus: lamp emission spectra and ocular safety. Remé, CE., Rol, P., Grothmann, K., et al.[2007]

Bright light therapy can effectively reset the sleep-wake cycle in individuals with circadian rhythm sleep disorders, improving sleep quality and daytime alertness.

The success of bright light therapy is highly dependent on the timing of light exposure within the circadian cycle, making it crucial to follow specific guidelines for its safe and effective use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm sleep disorders with light. Gooley, JJ.[2020]

Bright light therapy is effective for treating seasonal affective disorder and may also benefit various circadian rhythm sleep disorders, such as delayed and advanced sleep phase syndromes, based on a review of existing literature.

This therapy is relatively safe and its success relies on timing, suggesting that personalized approaches to treatment could enhance its effectiveness in managing sleep-wake rhythm misalignments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Photoperiod phototherapy and wakefulness-sleep rhythm disorders]. Poirrier, R.[2006]

Light therapy is being used more frequently to treat various sleep and psychiatric conditions, such as circadian rhythm sleep disorders and seasonal affective disorder, highlighting its growing importance in clinical practice.

Understanding the neural mechanisms behind circadian rhythms is essential for leveraging light therapy effectively, as it can significantly influence brain function and improve mood and sleep disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Illuminating rationale and uses for light therapy. Shirani, A., St Louis, EK.[2021]

References

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

Treatment of delirium with phototherapy: a case report. [2020]

2. Australia pubmed.ncbi.nlm.nih.gov

Case of a non-24 h sleep-wake syndrome patient improved by phototherapy. [2004]

3. France pubmed.ncbi.nlm.nih.gov

[Treating circadian sleep-wake disorders by light]. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Dose-response effects of light therapy on sleepiness and circadian phase shift in shift workers: a meta-analysis and moderator analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Therapy of circadian rhythm disorders in chronic fatigue syndrome: no symptomatic improvement with melatonin or phototherapy. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Bright light therapy in focus: lamp emission spectra and ocular safety. [2007]

8. Singapore pubmed.ncbi.nlm.nih.gov

Treatment of circadian rhythm sleep disorders with light. [2020]

9. France pubmed.ncbi.nlm.nih.gov

[Photoperiod phototherapy and wakefulness-sleep rhythm disorders]. [2006]

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

Illuminating rationale and uses for light therapy. [2021]