Back to resultsDaily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
Primary Purpose
Stroke, Traumatic Brain Injury, Non-traumatic Brain Injury
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Philips GoLite Blu HF3429/60
Philips LivingColor Aura 70998/60/48
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- 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
- Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment
Exclusion Criteria:
- 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
Sites / Locations
- St. Luke's Rehabilitation InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Blue Light
Red Light
Arm Description
Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM
Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM
Outcomes
Primary Outcome Measures
Total Sleep Time
24/7 recording of total amount of time asleep via wrist-worn actigraph
Sleep Efficiency
Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph
Sleep Fragmentation Index
Recording of restlessness during a sleep period via wrist-worn actigraph
Frequency of Daytime Naps
Recording of number of naps during daytime via wrist-worn actigraph
Secondary Outcome Measures
Karolinska Sleepiness Scale
Patient-report measure of daytime sleepiness
Wits Pictorial Sleepiness Scale
Patient-report measure of daytime sleepiness
Fatigue Visual Analog Scale
Patient-report measure of global fatigue
Full Information
NCT ID
NCT03125967
First Posted
April 12, 2017
Last Updated
May 5, 2022
Sponsor
St. Luke's Rehabilitation Institute
Collaborators
Washington State University
1. Study Identification
Unique Protocol Identification Number
NCT03125967
Brief Title
Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
Official Title
Effects of Colored Light Exposure on Sleep Disturbance, Fatigue, and Functional Outcomes Following Acute Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Luke's Rehabilitation Institute
Collaborators
Washington State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Traumatic Brain Injury, Non-traumatic Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
Masking
Participant
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blue Light
Arm Type
Active Comparator
Arm Description
Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM
Arm Title
Red Light
Arm Type
Placebo Comparator
Arm Description
Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM
Intervention Type
Other
Intervention Name(s)
Philips GoLite Blu HF3429/60
Intervention Description
Exposure to daily morning colored light in the 440-485 nm wavelength range
Intervention Type
Other
Intervention Name(s)
Philips LivingColor Aura 70998/60/48
Intervention Description
Exposure to daily morning colored light in the 625-740 nm wavelength range
Primary Outcome Measure Information:
Title
Total Sleep Time
Description
24/7 recording of total amount of time asleep via wrist-worn actigraph
Time Frame
From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Title
Sleep Efficiency
Description
Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph
Time Frame
From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Title
Sleep Fragmentation Index
Description
Recording of restlessness during a sleep period via wrist-worn actigraph
Time Frame
From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Title
Frequency of Daytime Naps
Description
Recording of number of naps during daytime via wrist-worn actigraph
Time Frame
From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days
Secondary Outcome Measure Information:
Title
Karolinska Sleepiness Scale
Description
Patient-report measure of daytime sleepiness
Time Frame
Baseline and every 3 days plus at study completion, at least 10 days after consent
Title
Wits Pictorial Sleepiness Scale
Description
Patient-report measure of daytime sleepiness
Time Frame
Baseline and every 3 days plus at study completion, at least 10 days after consent
Title
Fatigue Visual Analog Scale
Description
Patient-report measure of global fatigue
Time Frame
Baseline and every 3 days plus at study completion, at least 10 days after consent
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Willing to complete baseline evaluations prior to inclusion in the study to include: sleepiness inventories, neuropsychological testing, self-report fatigue assessment
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Douglas L Weeks, PhD
Phone
509-473-6000
Email
weeksdl@st-lukes.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas L Weeks, PhD
Organizational Affiliation
St. Luke's Rehabilitation Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Luke's Rehabilitation Institute
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Douglas L. Weeks, PhD
Phone
509-939-1316
Email
WeeksDL@st-lukes.org
First Name & Middle Initial & Last Name & Degree
Douglas L. Weeks, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Daily Light Exposure for Sleep Disturbance, Fatigue, and Functional Outcomes in Acute Brain Injury
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