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

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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Douglas L Weeks, PhD; Phone Number: 509-473-6000; Email: weeksdl@st-lukes.org

Study Locations

• United States
  • Washington
    • Spokane, Washington, United States, 99202
      • Recruiting
      • St. Luke's Rehabilitation Institute
      • Contact: Douglas L. Weeks, PhD; Phone Number: 509-939-1316; Email: WeeksDL@st-lukes.org
      • Principal Investigator: Douglas L. Weeks, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Blue Light; 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; Exposure to daily morning colored light in the 440-485 nm wavelength range
PLACEBO_COMPARATOR: Red Light; 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; Exposure to daily morning colored light in the 625-740 nm wavelength range

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Luke's Rehabilitation Institute
• Collaborators: Washington State University
• Investigators: Principal Investigator: Douglas L Weeks, PhD, St. Luke's Rehabilitation Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sleep Wake Disorders; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries; Dyssomnias; Parasomnias; Brain Injuries, Traumatic
• Other Study ID Numbers: StLukesRI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No