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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03125967
• Other study ID #: StLukesRI
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 2022

Study information

• Verified date: May 2022
• Source: St. Luke's Rehabilitation Institute
• Contact: Douglas L Weeks, PhD
• Phone: 509-473-6000
• Email: weeksdl[@]st-lukes.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Dyssomnias
• Non-traumatic Brain Injury
• Parasomnias
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• Philips GoLite Blu HF3429/60
Exposure to daily morning colored light in the 440-485 nm wavelength range
• Philips LivingColor Aura 70998/60/48
Exposure to daily morning colored light in the 625-740 nm wavelength range

Locations

Country	Name	City	State
United States	St. Luke's Rehabilitation Institute	Spokane	Washington

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's Rehabilitation Institute	Washington State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	Karolinska Sleepiness Scale	Patient-report measure of daytime sleepiness	Baseline and every 3 days plus at study completion, at least 10 days after consent
Secondary	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
Secondary	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