Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.

Official Title
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Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury

Conditions
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Non-traumatic Brain Injury, Stroke, Traumatic Brain Injury

Intervention / Treatment
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* Other: Philips GoLite Blu HF3429/60
* Other: Philips LivingColor Aura 70998/60/48


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury Male or female, 18 to 85 years of age (to match limits of assessment instruments) Able to provide written informed consent or have a legally authorized representative that can provide written informed consent Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure) Normal hearing or corrected to normal hearing Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment Exclusion Criteria: History of epileptic or other seizure disorder Cataract surgery in the past 12 months Significant visual impairment affecting light reaching the retina/performance of the retina: cataracts, macular degeneration, diabetic retinopathy, congenital blindness, total blindness, glaucoma, or retinal detachment Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's) Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome Neurological disorders other than those attributed to the primary diagnosis, including multiple sclerosis, Parkinson's disease, Huntington's disease, Alzheimer's disease or other dementias, amyotrophic lateral sclerosis) Bipolar diagnosis Females who are pregnant as determined from subject's medical records or who are breastfeeding In active withdrawal from alcohol or street drugs Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Blue Light<br>Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM | Other: Philips GoLite Blu HF3429/60<br>* Exposure to daily morning colored light in the 440-485 nm wavelength range<br>|
| Placebo Comparator: Red Light<br>Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM | Other: Philips LivingColor Aura 70998/60/48<br>* Exposure to daily morning colored light in the 625-740 nm wavelength range<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Sleep Time | 24/7 recording of total amount of time asleep via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days | 
| Sleep Efficiency | Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days | 
| Sleep Fragmentation Index | Recording of restlessness during a sleep period via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days | 
| Frequency of Daytime Naps | Recording of number of naps during daytime via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Karolinska Sleepiness Scale | Patient-report measure of daytime sleepiness | Baseline and every 3 days plus at study completion, at least 10 days after consent | 
| Wits Pictorial Sleepiness Scale | Patient-report measure of daytime sleepiness | Baseline and every 3 days plus at study completion, at least 10 days after consent | 
| Fatigue Visual Analog Scale | Patient-report measure of global fatigue | Baseline and every 3 days plus at study completion, at least 10 days after consent |