- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214212
TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI (TWILIGHT)
TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.
This study proposes to investigate how well Bright White Light Therapy will work in the acute inpatient rehabilitation units for people whom have experienced a traumatic brain injury for the purpose of treating sleep disruption. Participants will be assessed based on sleep efficiency, thinking abilities, therapy participation, and perception of fatigue/sleepiness. In previous studies dim red light has not had the same effects on function as bright white light, and will be chosen for use as a placebo. Each subject will be randomized to receive 30 minutes of either Bright White Light Therapy or Red Light Treatment each morning for 10 days.
To measure the effect of this treatment, the investigators will measure the each participants sleep daily by using an actigraph watch. This watch will record movement continuously. The investigators will also measure the subjects' report of how well they slept, whether fatigue is present, and how attentive they are before and after treatment.
Research Hypothesis:
In persons with TBI, prospectively compare overnight sleep in a cohort exposed to morning Bright White Light with a comparison group exposed to Red Light in an acute inpatient rehabilitation setting.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
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Seattle, Washington, United States, 98109
- Harborview Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Have experienced a moderate to severe TBI.
Defined by any of the following:
- Loss of Consciousness greater than 30 minutes.
- Emergency Room admission with a Glasgow Coma Scale of 12 or below.
- Intracranial abnormalities on imaging.
Post-traumatic amnesia that lasts more than 24 hours.
- Admitted to acute inpatient rehabilitation unit at Harborview Medical Center within 3 months of their Traumatic Brain Injury.
- Able to communicate in English.
- Between the ages of 18 and 70 years old
- Have a clinician rating of the presence of a sleep disturbance (using the Makley scale)
- Have some vision in one or both eyes.
- Have a Body Mass Index lower than 40 kg/m2
Exclusion Criteria:
Unable to enroll if any of the following are true
- Complete blindness
- Absence of eye opening or disorders of consciousness (Rancho level 1-3).
- Tetraplegia with less than antigravity strength in all myotomes caudal to C6 level given the limitations on measuring movements with actigraphy in this population (i.e. cannot reliably detect upper extremity or lower extremity movement with this level of paralysis).
- Past medical history of retinal pathology
- Past medical history of light sensitivity
- Past medical history of narcolepsy
- Past medical history of bipolar disorder
- Past medical history of obstructive sleep apnea
- Suspected sleep apnea. (Determined by administering the Berlin questionnaire)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Red Light (RL)
Intervention/Device: This patient group will receive 30 minutes of red light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms. |
The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table.
The participant will spend 30 minutes with the eyes open in front of the device.
This will occur each morning for 10 days.
Other Names:
|
Experimental: Bright White Light (BWL)
Intervention/Device: This patient group will receive 30 minutes of bright white light daily for a period of 10 days in the morning. Identical baseline and outcome testing will be completed for both arms. |
The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table.
The participant will spend 30 minutes with the eyes open in front of the device.
This will occur each morning for 10 days.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Actigraphy Data
Time Frame: Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure
|
Sleep efficiency scores derived from actigraphy data will be the primary outcome.
We will set the Actiwatch to record activity data in 60-second intervals.
Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is "sleep" or "wake" (Cole RJ, 1992).
Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency and total sleep time scores obtained during a set night-time interval (2200 to 0600) as the primary index of sleep function, as has been used in previous publications[39, 40].
We will be comparing average between group differences between the BWL and RL groups at baseline and after 10 days of light therapy.
|
Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Barrow Neurological Institute Fatigue Scale (BNI-FS)
Time Frame: At Baseline and After 10 Days of Light Exposure
|
The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome. The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness. |
At Baseline and After 10 Days of Light Exposure
|
Functional Independence Measure (FIM) - Motor
Time Frame: Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)
|
Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community.
The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population.
Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.
|
Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)
|
Symbol Digit Modalities Test
Time Frame: Administered at Baseline and After 10 Days of Light Exposure
|
The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI.
The SDMT was administered at enrollment and after intervention.
The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research.
The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures).
Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.
|
Administered at Baseline and After 10 Days of Light Exposure
|
Positive and Negative Affect Schedule - Positive
Time Frame: Administered at Baseline and After 10 Days of Light Exposure
|
The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect.
The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely.
For the total positive score, a higher score indicates more positive affect.
affect.
Scores can range from 10-50 for Positive Affect.
|
Administered at Baseline and After 10 Days of Light Exposure
|
Positive and Negative Affect Schedule - Negative
Time Frame: Administered at baseline and after 10 days of light exposure
|
The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect.
The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely.
For the total negative score, a higher score indicates more negative affect.
affect.
Scores can range from 10-50 for Negative Affect.
|
Administered at baseline and after 10 days of light exposure
|
Karolinska Sleepiness Scale (KSS)
Time Frame: Administered at Baseline and after 10 Days of Light Exposure
|
The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.
|
Administered at Baseline and after 10 Days of Light Exposure
|
Makley Scale
Time Frame: A sleep log was completed every 2 hours during the night (2200 until 0600) on each patient by the unit nursing staff hours for 12 nights or until discharge from the hospital (2 nights baseline and after 10 nights of intervention light exposure)
|
The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows: 0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake. |
A sleep log was completed every 2 hours during the night (2200 until 0600) on each patient by the unit nursing staff hours for 12 nights or until discharge from the hospital (2 nights baseline and after 10 nights of intervention light exposure)
|
Functional Independence Measure (FIM) - Cognitive
Time Frame: Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)
|
Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community.
The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population.
Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item.
Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.
|
Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cooperation Measure (Therapy Outcome)
Time Frame: Collected at Baseline and after 10 days of light exposure
|
Cooperation Measure (Therapy Outcome).
Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10
Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.
|
Collected at Baseline and after 10 days of light exposure
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeanne M Hoffman, PhD, University of Washington
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00000219
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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