Sleep Stabilization + Light Therapy for Fibromyalgia

Overseen By Helen Burgess, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Chronic disease, Hearing problems, Pregnancy, others

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

Compensation: Varies

Number of Visits: 9

Duration: 4 weeks

390 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adjusting sleep schedules and using morning light therapy can ease fibromyalgia symptoms. Participants will either maintain a stable sleep routine, use light therapy glasses, or continue their usual sleep habits. The trial is designed for individuals diagnosed with fibromyalgia who have access to a private space for online visits. Those with fibromyalgia who can join virtual sessions from home may find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative approaches to managing fibromyalgia symptoms from home.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that light therapy is generally safe for most people. One study found no harmful effects from using red and near-infrared light, even though it penetrates deeply into the body. Another study suggested that LED light safely manages pain without drugs by helping the body release endorphins, which are natural pain relievers.

For improving sleep, research indicates that light therapy can stabilize sleep patterns and boost mood. It works by resetting the body's internal clock, making it easier to fall asleep. No evidence of harmful side effects exists, making it a safe option for people with fibromyalgia.

Overall, both light therapy and sleep stabilization appear well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for fibromyalgia because they introduce non-drug interventions focused on stabilizing sleep and utilizing light therapy. Unlike common treatments that often rely on medications such as pain relievers or antidepressants, these approaches aim to enhance the body's natural rhythms. Sleep stabilization involves maintaining a consistent sleep-wake schedule, which can help regulate the body's internal clock and potentially reduce fibromyalgia symptoms. Meanwhile, light therapy uses tailored exposure to light to influence sleep patterns and mood, offering a novel way to address the condition's underlying issues without medication. These treatments could provide new options for patients seeking alternative or complementary methods to manage their symptoms.

What evidence suggests that this trial's treatments could be effective for fibromyalgia?

Research has shown that light therapy, one of the treatments studied in this trial, can help manage fibromyalgia by reducing depression and improving sleep. It can also reset the body's internal clock, potentially boosting overall well-being. Some studies have found that photobiomodulation, a specific type of light therapy, can significantly reduce fatigue in people with fibromyalgia.

Additionally, sleep stabilization, another treatment arm in this trial, involves maintaining a regular sleep schedule and shows promise in reducing fibromyalgia symptoms. Aligning sleep patterns with natural light cycles may help alleviate symptoms. Early research suggests that combining a consistent sleep routine with light therapy, as explored in this trial, could be an effective non-drug treatment, offering relief with few side effects. ^{3 4 6 7 8}

Who Is on the Research Team?

Afton Hassett, PsyD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with fibromyalgia or myofascial pain syndrome who are interested in exploring how sleep stabilization and morning light therapy might affect their symptoms. Specific eligibility criteria details were not provided.

Inclusion Criteria

Meets 2016 revised diagnostic criteria for fibromyalgia (FM)

Has access to video conferencing (including web cameras and audio) and a private space for the remote study visits.

Exclusion Criteria

Other research participation

Significant chronic disease

Severe hearing or memory problems

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants' average wake-up time is recorded to tailor the timing of light therapy or sleep schedule

1 week

1 visit (virtual)

Treatment

Participants receive either morning light therapy or follow a fixed sleep schedule for 4 weeks

4 weeks

8 visits (virtual)

Follow-up

Participants are monitored for changes in fibromyalgia symptoms and pain levels after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Light Therapy
• Sleep Stabilization

Trial Overview

The study is examining the effects of regulated sleep patterns and exposure to morning light therapy on fibromyalgia-related symptoms, aiming to understand if these interventions can provide relief.

How Is the Trial Designed?

Group I: Sleep Stabilization Experimental Treatment 1 Intervention

All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the sleep stabilization arm are asked to follow a fixed sleep schedule tailored to their sleep during a baseline period. The treatment period is 4 weeks.

Group II: Light Therapy Experimental Treatment 1 Intervention

All participants will be asked to attend 8 virtual visits over 5 months. Participants randomized to the morning light therapy group are asked to wear the glasses for 1 hour per day. The timing of each person's therapy is tailored to their average wake up time during a baseline period. The treatment period is 4 weeks long.

Group III: Control Group, treatment as usual Active Control 1 Intervention

Participants will be asked to sleep as per usual.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

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]

In two case studies involving individuals with traumatic brain injury (TBI), an 8-week personalized in-home light therapy significantly reduced fatigue, sleep disturbance, and insomnia symptoms, demonstrating its potential efficacy as a treatment.

Participants reported high compliance (over 70%) and found the light therapy feasible and well-tolerated, with no serious side effects, indicating it could be a safe and acceptable intervention for improving quality of life after brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury: Two Case Studies. Connolly, LJ., Ponsford, JL., Rajaratnam, SMW., et al.[2021]

The Fibromyalgia Sleep Diary (FMSD) was developed as a patient-reported outcome measure specifically for assessing sleep disturbances in fibromyalgia patients, based on extensive qualitative research including literature reviews, expert interviews, and focus groups with patients.

Preliminary cognitive interviews indicated that the FMSD is relevant and accurately reflects the sleep issues experienced by fibromyalgia patients, such as poor sleep quality and difficulty staying asleep, supporting its content validity for future psychometric evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of sleep in patients with fibromyalgia: qualitative development of the fibromyalgia sleep diary. Kleinman, L., Mannix, S., Arnold, LM., et al.[2021]

The study evaluated the reliability of the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia, finding that both a 1-week and a 4-week recall period provided similar and high reliability for measuring sleep disturbances.

With 129 patients participating, the results indicated that the 1-week recall period is sufficiently reliable for assessing sleep issues in fibromyalgia, making it a practical option for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of a 1-week recall period for the Medical Outcomes Study Sleep Scale (MOS-SS) in patients with fibromyalgia. Sadosky, A., Dukes, E., Evans, C.[2021]

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]

A study involving 33 Veterans with mild traumatic brain injury (TBI) found that morning bright light therapy was feasible and well-accepted, with about 75% of participants rating the protocol favorably and high adherence rates (87% for lightbox use and 97% for sleep tracking).

Post-treatment, participants reported significant improvements in insomnia, mood, and pain, along with better sleep measured by actigraphy and favorable changes in blood biomarkers, suggesting that bright light therapy could be an effective intervention for sleep disturbances in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and preliminary efficacy for morning bright light therapy to improve sleep and plasma biomarkers in US Veterans with TBI. A prospective, open-label, single-arm trial. Elliott, JE., McBride, AA., Balba, NM., et al.[2022]

In a study of 100 drug-free fibromyalgia patients, those with an evening chronotype experienced more severe symptoms and poorer quality of life compared to morning or neither types, highlighting the importance of chronotype in managing fibromyalgia.

The evening chronotype accounted for an additional 21.9% of the variation in fibromyalgia severity, suggesting that considering a patient's chronotype could improve treatment responses and overall management of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship between chronotype, sleep disturbance, severity of fibromyalgia, and quality of life in patients with fibromyalgia. Türkoğlu, G., Selvi, Y.[2021]

A review of five randomized controlled trials found that light therapy generally had no significant impact on sleep macro-architecture measures like total sleep time and sleep efficiency in patients with insomnia, except for one trial that showed improved sleep efficiency with evening light therapy.

In patients with delayed sleep-wake phase disorder (DSWPD), bright light therapy significantly increased sleep latency in the morning, indicating that timing and intensity of light exposure can influence sleep patterns, but overall research on light therapy's effects on EEG sleep measures is still limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Light Therapy on Electroencephalographic Sleep in Sleep and Circadian Rhythm Disorders: A Scoping Review. Pun, TB., Phillips, CL., Marshall, NS., et al.[2023]

In a trial involving 64 women with fibromyalgia and insomnia, cognitive-behavioral therapy for insomnia (CBT-I) led to significant improvements in sleep quality, fatigue, daily functioning, pain catastrophizing, anxiety, and depression compared to a sleep hygiene education program.

The CBT-I group showed greater overall improvements in various clinical symptoms than the sleep hygiene group, highlighting its effectiveness as part of a comprehensive treatment plan for fibromyalgia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for insomnia and sleep hygiene in fibromyalgia: a randomized controlled trial. Martínez, MP., Miró, E., Sánchez, AI., et al.[2021]

A study involving 10 women with fibromyalgia found that both morning and evening bright light treatments improved function and pain sensitivity, but morning light treatment resulted in a clinically meaningful improvement in function, with over a 14% reduction in Fibromyalgia Impact Questionnaire scores.

Morning light treatment also significantly increased pain threshold compared to evening light, suggesting that advancing circadian timing may be a key mechanism for improving pain sensitivity in fibromyalgia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morning Versus Evening Bright Light Treatment at Home to Improve Function and Pain Sensitivity for Women with Fibromyalgia: A Pilot Study. Burgess, HJ., Park, M., Ong, JC., et al.[2018]

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]

Bright light therapy has been shown to significantly improve wake after sleep onset (WASO) in individuals with insomnia, based on a meta-analysis of 22 studies involving 685 participants.

While light therapy did not affect other sleep measures like sleep latency or total sleep time, it demonstrated potential for personalized treatment approaches by adjusting light exposure based on the type of insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy in insomnia disorder: A systematic review and meta-analysis. Chambe, J., Reynaud, E., Maruani, J., et al.[2023]

In a study of 35 adults aged 18 to 45 with mild traumatic brain injury, daily 30-minute sessions of blue light therapy for 6 weeks significantly improved sleep quality and reduced daytime sleepiness compared to placebo amber light therapy.

Participants receiving blue light therapy also reported lower levels of depression and post-concussion symptoms, suggesting that this nonpharmacological treatment could effectively address multiple issues related to sleep disruption after a mild traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Morning Blue Light Therapy Improves Daytime Sleepiness, Sleep Quality, and Quality of Life Following a Mild Traumatic Brain Injury. Raikes, AC., Dailey, NS., Shane, BR., et al.[2021]

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