Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury (NCT03125967) | Clinical Trial Compass
UnknownNot Applicable
Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
United States52 participantsStarted 2017-01-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Sleep Time
Timeframe: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
2
Sleep Efficiency
Timeframe: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
3
Sleep Fragmentation Index
Timeframe: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
4
Frequency of Daytime Naps
Timeframe: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
. 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