Morning Bright Light Therapy for TBI

Recruiting at 1 trial location

Overseen By Jonathan E Elliott, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Portland VA Medical Center

Disqualifiers: Bipolar, Macular degeneration, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 4 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether morning bright light therapy can improve sleep quality in Veterans who have experienced a traumatic brain injury (TBI). Many individuals with TBI face sleep issues such as insomnia and excessive daytime fatigue. Participants will either use a bright light box for an hour each morning for four weeks or join a group that does not use the therapy. Veterans not currently using a light box and without conditions like bipolar disorder or macular degeneration may be suitable for this trial. As an unphased study, this trial provides Veterans the chance to contribute to research that could enhance sleep therapies for those with TBI.

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

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

What prior data suggests that morning bright light therapy is safe for improving sleep in Veterans with TBI?

Research has shown that morning bright light therapy (MBLT) is a safe and well-accepted treatment. Studies have found that MBLT can improve sleep quality and alleviate other symptoms, even in individuals with traumatic brain injury (TBI). For instance, Veterans who used MBLT reported improvements in both physical and mental well-being. Additionally, MBLT is easy to use and generally considered helpful. These studies have reported no major side effects, indicating that MBLT is a safe choice for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Morning Bright Light Therapy is unique for treating traumatic brain injury (TBI) because it leverages natural light exposure to potentially improve mood and cognitive function. Unlike traditional treatments for TBI that often rely on medications and rehabilitation therapies, this approach focuses on regulating the body's internal clock, which can be disrupted after a brain injury. Researchers are excited about this treatment as it offers a non-invasive, easily accessible option that could complement existing therapies and provide quicker relief for some symptoms associated with TBI.

What evidence suggests that Morning Bright Light Therapy is effective for improving sleep in Veterans with TBI?

Research has shown that morning bright light therapy (MBLT) might improve sleep for people with traumatic brain injury (TBI). In this trial, some participants will engage in MBLT, which studies have found to be a practical and acceptable treatment for Veterans with TBI who have trouble sleeping. Reports also indicate that light therapy can lessen symptoms of post-traumatic stress disorder (PTSD), which often occurs alongside TBI. Another study suggested that bright light therapy can boost sleep, thinking skills, and emotional health after a mild TBI. While more research is needed, these findings suggest that MBLT could enhance sleep quality in Veterans with TBI. ^{1 2 4 6 7}

Who Is on the Research Team?

Miranda M Lim, MD, PhD

Principal Investigator

Portland VA Medical Center

Are You a Good Fit for This Trial?

This trial is for Veterans who have experienced traumatic brain injury or stress disorders and are having trouble with their sleep. It's not suitable for those who don't speak English, have macular degeneration, decision-making impairments, bipolar disorder, or are already using light therapy.

Inclusion Criteria

Veterans

Exclusion Criteria

History of bipolar disorder

Currently using a light box

I have a history of macular degeneration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Baseline questionnaires and 7 days of actigraphy are collected

1 week

1 visit (in-person)

Treatment

Participants engage in 60 minutes of morning bright light therapy daily for 4 weeks, with continuous actigraphy collection

4 weeks

Post-Treatment Assessment

Post-MBLT questionnaire data is collected

1 week

Follow-up

Follow-up questionnaire data is collected at 3 months post-MBLT

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Morning Bright Light Therapy

Trial Overview The study tests if Morning Bright Light Therapy (MBLT) can improve sleep quality in Veterans with traumatic brain injuries. Participants will use MBLT daily for 4 weeks and their sleep patterns will be monitored before, during, and three months after the therapy.

How Is the Trial Designed?

Group I: Morning Bright Light Therapy Experimental Treatment 1 Intervention

Subjects who engage in morning bight light therapy

Group II: Control Active Control 1 Intervention

Subjects who do not engage in morning bright light therapy

Morning Bright Light Therapy is already approved in United States, European Union for the following indications:

Approved in United States as Bright Light Therapy for:

• Seasonal Affective Disorder
• Nonseasonal Depression
• Circadian Rhythm Disorders
• Sleep Disturbances in Traumatic Brain Injury

Approved in European Union as Light Therapy for:

• Seasonal Affective Disorder
• Nonseasonal Depression
• Circadian Rhythm Disorders

Who Is Running the Clinical Trial?

Portland VA Medical Center

Lead Sponsor

Trials

44

Recruited

7,800+

Oregon Health and Science University

Collaborator

Trials

1,024

Recruited

7,420,000+

Published Research Related to This Trial

In a study involving 95 patients with bipolar and unipolar depression, morning bright light therapy (BLT) showed significantly higher response (50% vs. 27.9%) and remission rates (28.8% vs. 11.6%) compared to a placebo after 14 days of treatment, indicating its potential efficacy for drug-resistant depression.

While the overall improvement in depression scores (HDRS-21) was not significantly different between the BLT and placebo groups, BLT was particularly effective in patients whose previous treatments had not worked well, suggesting it may be beneficial for a specific subset of patients with non-seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A sham-controlled randomized trial of adjunctive light therapy for non-seasonal depression. Chojnacka, M., Antosik-Wójcińska, AZ., Dominiak, M., et al.[2019]

In a study involving 131 participants with recent traumatic brain injury, exposure to bright white light (BWL) for 30 minutes each morning did not improve sleep quality or duration compared to a control group receiving red light.

Despite previous indications that individuals with TBI often experience sleep difficulties, this study found no significant effects of phototherapy on sleep or related outcomes, suggesting a need for further research into effective treatments for sleep disorders following TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of phototherapy on sleep during acute rehabilitation after traumatic brain injury: a randomized controlled trial. Bell, KR., Fogelberg, D., Barber, J., et al.[2021]

In a study of 18 patients with moderate-severe traumatic brain injury (TBI), it was found that they were awake for about 3 hours (24% of the time) during the night, indicating significant sleep disruption.

Higher levels of sound and increased movement in the hospital environment were linked to a greater likelihood of nighttime awakenings, while changes in light levels did not have a significant effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambient Stimuli Perpetuate Nighttime Sleep Disturbances in Hospital Patients With TBI. Williams, ET., Bubu, OM., Seixas, A., et al.[2022]

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]

In a study of 62 individuals recovering from mild traumatic brain injuries (mTBIs), daily morning blue light therapy (BLT) for 6 weeks significantly increased gray matter volume in 15 brain regions, including areas related to sleep regulation and cognitive function.

Participants receiving BLT also showed improved functional connectivity in brain networks associated with attention and cognitive control, which correlated with self-reported reductions in daytime sleepiness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Morning Blue Light Therapy for Post-mTBI Sleep Disruption: Effects on Brain Structure and Function. Raikes, AC., Dailey, NS., Forbeck, B., et al.[2021]

Bright light therapy (BLT) has been shown to be effective for treating both seasonal and non-seasonal depression, based on a systematic review of 67 studies that included randomized controlled trials.

While BLT shows promise for mood disorders, the evidence for its efficacy in other mental and behavioral illnesses is limited, indicating a need for higher quality studies to confirm its benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy for mental and behavioral illness: A systematic umbrella review. Reis, DJ., Hoffberg, AS., Stearns-Yoder, KA., et al.[2023]

In a pilot study involving 30 renal transplant recipients, morning bright light therapy (BLT) for 3 weeks led to a significant improvement in sleep timing, with participants waking up 24 minutes earlier on average.

While BLT showed preliminary benefits in improving subjective feelings and depressive symptoms, these changes were not statistically significant, indicating the need for further research to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of bright light therapy on sleep and circadian rhythms in renal transplant recipients: a pilot randomized, multicentre wait-list controlled trial. Burkhalter, H., Wirz-Justice, A., Denhaerynck, K., et al.[2016]

In a study involving 20 healthy participants, a new bright light therapy (BLT) cabin showed no reports of headaches, which are a common side effect of conventional BLT devices.

While some participants experienced blurring of vision (21.1% prevalence), the absence of headaches suggests that this new technology may improve patient adherence to treatment for seasonal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. Leichtfried, V., Kantner-Rumplmair, W., Bartenbach, C., et al.[2014]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35421086/

Feasibility and preliminary efficacy for morning bright light ... Morning bright light therapy is a feasible and acceptable intervention that shows preliminary efficacy to treat disrupted sleep in Veterans with TBI.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9009710/

Feasibility and preliminary efficacy for morning bright light ... Additionally, light therapy was also recently shown to improve post-traumatic stress disorder (PTSD) symptom severity in Veterans with PTSD, ...

3. clinicaltrials.gov clinicaltrials.gov/show/NCT03785600

NCT03785600 | Improving Sleep in Veterans With TBI The investigators predict that the proposed intervention, morning bright light therapy, if found effective, will be cost-effective, rapidly deployable, and ...

4. pnnl.gov pnnl.gov/publications/feasibility-and-preliminary-efficacy-morning-bright-light-therapy-improve-sleep-and

Feasibility and preliminary efficacy for morning bright light ... Morning bright light therapy is a feasible and highly acceptable intervention that shows preliminary efficacy to treat disrupted sleep in ...

5. aasm.org aasm.org/bright-light-therapy-may-improve-sleep-and-promote-recovery-in-patients-with-mild-tbi/

Bright light therapy may improve sleep and promote ... A new study suggests that bright light therapy may improve sleep, cognition, emotion and brain function following mild traumatic brain injury (TBI).

6. physiology.org physiology.org/detail/news/2021/04/27/light-therapy-helps-veterans-treated-for-traumatic-brain-injury

Light Therapy Helps Veterans Treated for Traumatic Brain ... ... traumatic brain injury (TBI) with morning bright light therapy (MBLT) improved physical and mental symptoms for participants. The team will ...

7. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2021.651392/full

Factors Associated With Response to Pilot Home-Based ... We conducted a trial of in-home light therapy to alleviate fatigue and sleep disturbance. The aim of the current study was to identify factors moderating ...