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

NCT03125967 | Unknown

• 1 other identifier: StLukesRI
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Traumatic Brain Injury; Non-traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Karolinska Sleepiness Scale

  Baseline and every 3 days plus at study completion, at least 10 days after consent

• Wits Pictorial Sleepiness Scale

  Baseline and every 3 days plus at study completion, at least 10 days after consent

• Fatigue Visual Analog Scale

  Baseline and every 3 days plus at study completion, at least 10 days after consent

Study Arms (2)

Blue Light

ACTIVE COMPARATOR

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

Red Light

PLACEBO COMPARATOR

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

Interventions

Philips GoLite Blu HF3429/60 OTHER

Exposure to daily morning colored light in the 440-485 nm wavelength range

Blue Light

Philips LivingColor Aura 70998/60/48 OTHER

Exposure to daily morning colored light in the 625-740 nm wavelength range

Red Light

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• In active withdrawal from alcohol or street drugs
• Unwillingness to refrain from wearing tinted glasses or contact lenses during light exposure

Sponsors & Collaborators

• St. Luke's Rehabilitation Institute: lead
• Washington State University: collaborator

Study Sites (1)

St. Luke's Rehabilitation Institute

Spokane, Washington, 99202, United States

RECRUITING

Related Publications (1)

• Weeks DL, Crooks E, O'Brien KE, Sprint G, Carter GT, Honn KA. A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study. Contemp Clin Trials. 2024 Dec;147:107736. doi: 10.1016/j.cct.2024.107736. Epub 2024 Nov 6.

  PMID: 39510247 DERIVED

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Douglas L Weeks, PhD

  St. Luke's Rehabilitation Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Douglas L Weeks, PhD

CONTACT

509-473-6000; weeksdl@st-lukes.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 24, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 9, 2022

Record last verified: 2022-05

Locations

US (1)