Morning Bright Light Therapy for TBI
Recruiting in Palo Alto (17 mi)
Overseen ByMiranda M Lim, MD, PhD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Portland VA Medical Center
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.
12345Is 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.
12678How 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.
13679Eligibility 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.Exclusion Criteria
I have a history of macular degeneration.
I am unable to make my own medical decisions.
I do not speak English.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Morning Bright Light TherapyExperimental Treatment1 Intervention
Subjects who engage in morning bight light therapy
Group II: ControlActive Control1 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
VA Portland Health Care SystemPortland, OR
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Who is running the clinical trial?
Portland VA Medical CenterLead Sponsor
Oregon Health and Science UniversityCollaborator
References
The effect of phototherapy on sleep during acute rehabilitation after traumatic brain injury: a randomized controlled trial. [2021]Objective: To examine the impact of bright white light (BWL) exposure on sleep quality in persons with recent traumatic brain injury (TBI).Design: Randomized, controlled device-sham studySetting: 3 TBI Model System inpatient rehabilitation unitsParticipants: 131 participants (mean 40.9 years, 68% male)Intervention: Intervention group (N = 65) received BWL (1260 lux at 20 inches, 440-480 nanometers length) for 30 minutes each morning at 12-24 inches from the face. Control group (N = 66) received red light (<450 lux, no light between 440 and 480 nanometers) for the same period. Planned intervention was maximum of 10 treatments or until discharge.Main Outcome Measure: Sleep duration and quality using actigraphic recording.Results: There were no differences found between groups on the primary outcomes nor on the secondary outcomes (sleepiness, mood, cooperation with therapy).Conclusion: BWL treatment during acute rehabilitation hospitalization does not appear to impact sleep or measures commonly associated with sleep. While studies have indicated common complaints of sleep difficulties after TBI, we were unable to document an effect for phototherapy as a treatment. With growing evidence of the effect of sleep on neural repair and cognition, further study is needed to understand the nature and treatment of sleep disorders after TBI.Clinicaltrials.gov Identifier: NCT02214212.
Development of a Home-Based Light Therapy for Fatigue Following Traumatic Brain Injury: Two Case Studies. [2021]Background and Objectives: Fatigue and sleep disturbance negatively impact quality of life following brain injury and there are no established treatments. Building on research showing efficacy of blue light therapy delivered via a lightbox in reducing fatigue and daytime sleepiness after traumatic brain injury (TBI), this paper describes the development and implementation of a novel in-home light therapy to alleviate fatigue and sleep disturbance in two case studies. Methods: During the 8-week lighting intervention, participants' home lighting was adjusted to provide high intensity, blue-enriched (high melanopic) light all day as a stimulant and dimmer, blue-depleted (low melanopic) light for 3 h before sleep as a soporific. The sham 8-week control condition resembled participants' usual (baseline) lighting conditions (3,000-4,000 K all day). Lighting conditions were crossed-over. Outcomes were measures of fatigue, subjective daytime sleepiness, sleep quality, insomnia symptoms, psychomotor vigilance and mood. Case study participants were a 35-year old male (5 years post-TBI), and a 46-year-old female (22 years post-TBI). Results: The relative proportion of melanopic lux was greater in Treatment lighting than Control during daytime, and lower during evenings. Participants found treatment to be feasible to implement, and was well-tolerated with no serious side effects noted. Self-reported compliance was >70%. Both cases demonstrated reduced fatigue, sleep disturbance and insomnia symptoms during the treatment lighting intervention. Case 2 additionally showed reductions in daytime sleepiness and depressive symptoms. As expected, symptoms trended toward baseline levels during the control condition. Discussion: Treatment was positively received and compliance rates were high, with no problematic side-effects. Participants expressed interest in continuing the ambient light therapy in their daily lives. Conclusions: These cases studies demonstrate the acceptability and feasibility of implementing a personalized in-home dynamic light treatment for TBI patients, with evidence for efficacy in reducing fatigue and sleep disturbance. Clinical Trial Registration:www.anzctr.org.au, identifier: ACTRN12617000866303.
Daily Morning Blue Light Therapy for Post-mTBI Sleep Disruption: Effects on Brain Structure and Function. [2021]Background: Mild traumatic brain injuries (mTBIs) are associated with novel or worsened sleep disruption. Several studies indicate that daily morning blue light therapy (BLT) is effective for reducing post-mTBI daytime sleepiness and fatigue. Studies demonstrating changes in brain structure and function following BLT are limited. The present study's purpose is to identify the effect of daily morning BLT on brain structure and functional connectivity and the association between these changes and self-reported change in post-mTBI daytime sleepiness. Methods: A total of 62 individuals recovering from a mTBI were recruited from two US cities to participate in a double-blind placebo-controlled trial. Eligible individuals were randomly assigned to undergo 6 weeks of 30 min daily morning blue or placebo amber light therapy (ALT). Prior to and following treatment all individuals completed a comprehensive battery that included the Epworth Sleepiness Scale as a measure of self-reported daytime sleepiness. All individuals underwent a multimodal neuroimaging battery that included anatomical and resting-state functional magnetic resonance imaging. Atlas-based regional change in gray matter volume (GMV) and region-to-region functional connectivity from baseline to post-treatment were the primary endpoints for this study. Results: After adjusting for pre-treatment GMV, individuals receiving BLT had greater GMV than those receiving amber light in 15 regions of interest, including the right thalamus and bilateral prefrontal and orbitofrontal cortices. Improved daytime sleepiness was associated with greater GMV in 74 ROIs, covering many of the same general regions. Likewise, BLT was associated with increased functional connectivity between the thalamus and both prefrontal and orbitofrontal cortices. Improved daytime sleepiness was associated with increased functional connectivity between attention and cognitive control networks as well as decreased connectivity between visual, motor, and attention networks (all FDR corrected p < 0.05). Conclusions: Following daily morning BLT, moderate to large increases in both gray matter volume and functional connectivity were observed in areas and networks previously associated with both sleep regulation and daytime cognitive function, alertness, and attention. Additionally, these findings were associated with improvements in self-reported daytime sleepiness. Further work is needed to identify the personal characteristics that may selectively identify individuals recovering from a mTBI for whom BLT may be optimally beneficial.
Daily Morning Blue Light Therapy Improves Daytime Sleepiness, Sleep Quality, and Quality of Life Following a Mild Traumatic Brain Injury. [2021]Identify the treatment effects of 6 weeks of daily 30-minute sessions of morning blue light therapy compared with placebo amber light therapy in the treatment of sleep disruption following mild traumatic brain injury.
Ambient Stimuli Perpetuate Nighttime Sleep Disturbances in Hospital Patients With TBI. [2022]The effect of the ambient environment, sound, light, and movement, on the nighttime rest-activity of patients hospitalized with moderate-severe traumatic brain injury (TBI) is poorly understood. The purpose of this study was to examine how sound, light, and movement in these patients' hospital rooms may contribute to nighttime awakenings.
A sham-controlled randomized trial of adjunctive light therapy for non-seasonal depression. [2019]The aim of the study was to examine the efficacy and safety of morning bright light therapy (BLT) in the treatment of patients with a current major depressive episode (MDE) in bipolar and unipolar disorder without a seasonal pattern. It was a randomized, sham-controlled trial.
The effect of bright light therapy on sleep and circadian rhythms in renal transplant recipients: a pilot randomized, multicentre wait-list controlled trial. [2016]This study assessed the effect and feasibility of morning bright light therapy (BLT) on sleep, circadian rhythms, subjective feelings, depressive symptomatology and cognition in renal transplant recipients (RTx) diagnosed with sleep-wake disturbances (SWD). This pilot randomized multicentre wait-list controlled trial included 30 home-dwelling RTx randomly assigned 1:1 to either 3 weeks of BLT or a wait-list control group. Morning BLT (10 000 lux) was individually scheduled for 30 min daily for 3 weeks. Wrist actimetry (measuring sleep and circadian rhythms), validated instruments (subjective feelings and cognition) and melatonin assay (circadian timing) were used. Data were analysed via a random-intercept regression model. Of 30 RTx recipients (aged 58 ± 15, transplanted 15 ± 6 years ago), 26 completed the study. While BLT had no significant effect on circadian and sleep measures, sleep timing improved significantly. The intervention group showed a significant get-up time phase advance from baseline to intervention (+24 min) [(standardized estimates (SE): -0.23 (-0.42; -0.03)] and a small (+14 min) but significant bedtime phase advance from intervention to follow-up (SE: -0.25 (-0.41; -0.09). Improvement in subjective feelings and depressive symptomatology was observed but was not statistically significant. Bright light therapy showed preliminary indications of a beneficial effect in RTx with sleep-wake disturbances. (ClinicalTrials.gov number: NCT01256983).
Bright light therapy: Minimizing light induced side effects with an innovative light setup. [2014]Abstract Objective. Bright light therapy (BLT) is regarded to be an effective treatment against seasonal depression (SAD). Conventional BLT devices are reported to evoke few, but inconvenient symptoms. This study evaluated side effects associated with a new technology for BLT in a healthy population. Methods. In an uncontrolled study design 20 healthy Caucasians received 30 min light exposures on three consecutive mornings. Immediate side effects were evaluated using questionnaires. The new light cabin was equipped with fluorescent lamps (light colour 965 = 6,500 K, CRI >90) with a maximum illumination of 5,000 lux and a maximum luminance of 1,500 cd/m(2). Occurrence of headache was determined to be the main objective. Results. Nineteen volunteers completed the study. No headache was reported at any time. With a prevalence of 21.1% blurring was observed to occur more often after light exposure. Conclusion. With the evaluated light cabin the most prominent short-term side effects of BLT can be minimized, enhancing patients' adherence.
Bright light therapy for mental and behavioral illness: A systematic umbrella review. [2023]Bright light therapy (BLT) is a promising non-pharmacological treatment for a range of psychiatric conditions. The goal of this review was to provide a comprehensive overview of the efficacy of BLT across mental and behavioral illnesses. Using systematic umbrella review methodology, we searched Ovid MEDLINE, Embase, PsycInfo, Web of Science, and Google Scholar for systematic reviews of randomized controlled trials (RCTs) evaluating BLT for any mental or behavioral illness from the date of inception until March 2021. Review quality was assessed using the AMSTAR 2 tool and summary efficacy data were extracted from recent reviews. Of 792 unique records, 67 systematic reviews were included which targeted a range of disorders related to mood, neurocognition, sleep, and eating. Recent meta-analyses targeting seasonal or non-seasonal depression found that BLT outperformed light-related control conditions. Reviews of other disorders identified few RCTs and generally did not support the efficacy of BLT for various outcomes. Overall, the extant literature supports the efficacy of BLT for seasonal and non-seasonal depression, although higher quality systematic reviews are needed to increase confidence in these findings. There was no specific funding for this review, and it was preregistered on Prospero (ID: CRD42021240751).