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

Not Applicable

• Conditions: Stroke; Traumatic Brain Injury; Non-traumatic Brain Injury
• Interventions: Other: Philips GoLite Blu HF3429/60; Other: Philips LivingColor Aura 70998/60/48

• Registration Number: NCT03125967
• Lead Sponsor: St. Luke's Rehabilitation Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-24
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-05
• Last Update Posted: 2022-05-09
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Blue Light	Philips GoLite Blu HF3429/60	Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM
Red Light	Philips LivingColor Aura 70998/60/48	Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

St. Luke's Rehabilitation Institute; 🇺🇸 Spokane, Washington, United States