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

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ClinicalTrials.gov Identifier: NCT03125967
Recruitment Status : Recruiting
First Posted : April 24, 2017
Last Update Posted : August 1, 2018
Sponsor:
Collaborator:
Washington State University
Information provided by (Responsible Party):
Douglas L. Weeks, 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.

Condition or disease Intervention/treatment Phase
Stroke Traumatic Brain Injury Non-traumatic Brain Injury Other: Philips GoLite Blu HF3429/60 Other: Philips LivingColor Aura 70998/60/48 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Total Sleep Time [ Time Frame: 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

  2. Sleep Efficiency [ Time Frame: 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

  3. Sleep Fragmentation Index [ Time Frame: 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

  4. Frequency of Daytime Naps [ Time Frame: 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


Secondary Outcome Measures :
  1. Karolinska Sleepiness Scale [ Time Frame: Baseline and every 3 days plus at study completion, at least 10 days after consent ]
    Patient-report measure of daytime sleepiness

  2. Wits Pictorial Sleepiness Scale [ Time Frame: Baseline and every 3 days plus at study completion, at least 10 days after consent ]
    Patient-report measure of daytime sleepiness

  3. Fatigue Visual Analog Scale [ Time Frame: Baseline and every 3 days plus at study completion, at least 10 days after consent ]
    Patient-report measure of global fatigue



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03125967


Contacts
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Contact: Douglas L Weeks, PhD 509-473-6000 weeksdl@st-lukes.org

Locations
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United States, Washington
St. Luke's Rehabilitation Institute Recruiting
Spokane, Washington, United States, 99202
Contact: Douglas L. Weeks, PhD    509-939-1316    WeeksDL@st-lukes.org   
Principal Investigator: Douglas L. Weeks, PhD         
Sponsors and Collaborators
St. Luke's Rehabilitation Institute
Washington State University
Investigators
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Principal Investigator: Douglas L Weeks, PhD St. Luke's Rehabilitation Institute

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Responsible Party: Douglas L. Weeks, Director of Research, St. Luke's Rehabilitation Institute
ClinicalTrials.gov Identifier: NCT03125967     History of Changes
Other Study ID Numbers: StLukesRI
First Posted: April 24, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Fatigue
Brain Injuries, Traumatic
Dyssomnias
Sleep Wake Disorders
Parasomnias
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Signs and Symptoms
Mental Disorders
Neurologic Manifestations