Clinical trial NCT03125967: Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
Official title: Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Traumatic Brain Injury
Non-traumatic Brain Injury
Lead sponsor: St. Luke's Rehabilitation Institute
Sponsor class: OTHER
Collaborators: name: Washington State University
First posted: 2017-04-24
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Inpatient admission to St. Luke's Rehabilitation Institute for stroke, traumatic brain injury, or non-traumatic brain injury
2. Male or female, 18 to 85 years of age (to match limits of assessment instruments)
3. Able to provide written informed consent or have a legally authorized representative that can provide written informed consent
4. Stable neurologic status, as determined from subject's medical records and the study physician's opinion based on no new or changing symptoms
5. Normal vision or corrected to normal vision (if glasses or contacts are tinted, willing to remove during light exposure)
6. Normal hearing or corrected to normal hearing
7. Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment

Exclusion Criteria:

1. History of epileptic or other seizure disorder
2. Cataract surgery in the past 12 months
3. 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
4. Endorsement of suicidal ideation on the PHQ-9 depression screen (standard of care admission assessment at St. Luke's)
5. Pre-injury diagnosis of a sleep disorder, including: sleep apnea, insomnia, narcolepsy or periodic limb movement syndrome
6. 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)
7. Bipolar diagnosis
8. Females who are pregnant as determined from subject's medical records or who are breastfeeding
9. In active withdrawal from alcohol or street drugs
10. Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure

Primary outcomes:
measure: Total Sleep Time
timeFrame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
measure: Sleep Efficiency
timeFrame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
measure: Sleep Fragmentation Index
timeFrame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
measure: Frequency of Daytime Naps
timeFrame: From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Secondary outcomes:
measure: Karolinska Sleepiness Scale
timeFrame: Baseline and every 3 days plus at study completion, at least 10 days after consent
measure: Wits Pictorial Sleepiness Scale
timeFrame: Baseline and every 3 days plus at study completion, at least 10 days after consent
measure: Fatigue Visual Analog Scale
timeFrame: Baseline and every 3 days plus at study completion, at least 10 days after consent
Other outcomes:
Locations:
city: Spokane
country: United States
facility: St. Luke's Rehabilitation Institute
state: Washington
Study officials:
affiliation: St. Luke's Rehabilitation Institute
name: Douglas L Weeks, PhD
role: PRINCIPAL_INVESTIGATOR
References: