Morning Bright Light Therapy for TBI

Overseen by Miranda M Lim, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Portland VA Medical Center

Disqualifiers: Bipolar, Macular degeneration, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

One of the principal complicating factors associated with traumatic brain injury (TBI) is sleep-wake disturbances (e.g., insomnia, excessive daytime sleepiness, and circadian rhythm sleep disorders). Morning bright light therapy (MBLT) has been shown to improve sleep quality in a variety of conditions, but little has been done investigating the utility of MBLT in improving sleep in Veterans with TBI. This proposal aims to determine the effect of MBLT on sleep quality in Veterans with TBI. Veterans with and without TBI will be recruited from the VA Portland Health Care System. Baseline questionnaires and 7 days of actigraphy will be collected prior to engaging in 60 minutes of MBLT daily for 4 weeks, during which actigraphy will also be collected continuously. Post-MBLT questionnaire data will be collected, and follow-up questionnaire data will be collected at 3 months post-MBLT.

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 data supports the effectiveness of the treatment Morning Bright Light Therapy for TBI?

Research shows that daily morning blue light therapy can improve daytime sleepiness, sleep quality, and quality of life for people with mild traumatic brain injuries. It also suggests that this therapy may lead to positive changes in brain structure and function, which are linked to better sleep and alertness. ^{1 2 3 4 5}

Is morning bright light therapy safe for humans?

Morning bright light therapy is generally considered safe for humans, with studies showing it is well-tolerated and has few side effects. Some people may experience mild symptoms like blurring, but serious side effects are rare. ^{1 2 6 7 8}

How is Morning Bright Light Therapy different from other treatments for TBI?

Morning Bright Light Therapy is unique because it uses exposure to bright light, typically in the morning, to potentially improve sleep and cognitive function after a traumatic brain injury. Unlike medications, this non-drug approach aims to influence brain structure and function, as well as sleep patterns, through light exposure. ^{1 3 6 7 9}

Research Team

Miranda M Lim, MD, PhD

Principal Investigator

Portland VA Medical Center

Eligibility Criteria

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

Currently using a light box

History of bipolar disorder

I have a history of macular degeneration.

Trial Timeline

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

Treatment Details

Interventions

• Morning Bright Light Therapy (Behavioural Intervention)

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.

Participant Groups

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

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+

John Hunter

Oregon Health and Science University

Chief Medical Officer since 2024

MD, specific details unavailable

Ann Madden Rice

Oregon Health and Science University

Chief Executive Officer

FACHE certification, extensive leadership experience in academic health centers

Findings from Research

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 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]

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]

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 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]

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]

References

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

The effect of phototherapy on sleep during acute rehabilitation after traumatic brain injury: a randomized controlled trial. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Development of a Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury: Two Case Studies. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Daily Morning Blue Light Therapy for Post-mTBI Sleep Disruption: Effects on Brain Structure and Function. [2021]

4. United States 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. [2021]

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

Ambient Stimuli Perpetuate Nighttime Sleep Disturbances in Hospital Patients With TBI. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

A sham-controlled randomized trial of adjunctive light therapy for non-seasonal depression. [2019]

7. Switzerland 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. [2016]

8. England pubmed.ncbi.nlm.nih.gov

Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Bright light therapy for mental and behavioral illness: A systematic umbrella review. [2023]