TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI (TWILIGHT)
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|ClinicalTrials.gov Identifier: NCT02214212|
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : November 24, 2017
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.
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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury TBI Sleep||Device: Bright White Light (BWL) Device: Red Light (RL)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.|
|Actual Study Start Date :||December 2013|
|Actual Primary Completion Date :||March 2017|
|Actual Study Completion Date :||March 2017|
Active Comparator: Red Light (RL)
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.
Device: Red Light (RL)
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 Name: Litebook® (Red Light)
Experimental: Bright White Light (BWL)
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.
Device: Bright White Light (BWL)
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 Name: Litebook® (Bright White Light)
- Actigraphy data [ Time Frame: 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.
- Makley Scale [ Time Frame: A sleep log will be 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 10 nights of intervention) ]
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.
- Barrow Neurological Institute Fatigue Scale (BNI-FS) [ Time Frame: Administered at baseline prior to intervention and at Day 10 after completion of intervention. ]The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. We will ask the clinical staff involved in the care of these subjects to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.
- Likert scale for clinical staff acceptance [ Time Frame: Administered after Day 10 of intervention and after completion of subject outcome assessment. ]We will ask the clinical staff involved in the care of these subjects to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.
- Functional Independence Measure (FIM) [ 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.
- Symbol Digit Modalities Test [ Time Frame: Administered at baseline and after Day 10 of intervention. ]The 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 will be administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the Symbol Digit Modalities Test as CORE common data elements in TBI outcomes research.
- Positive and Negative Affect Schedule [ Time Frame: Administered at baseline and after Day 10 of intervention. ]The 20-item Positive and Negative Affect Schedule (PANAS), developed with a sample of undergraduate students and validated with adult populations, comprises two mood scales, one measuring positive affect and the other measuring negative affect. Each item is rated on a 5-point scale ranging from 1 = very slightly or not at all to 5 = extremely to indicate the extent to which the respondent has felt this way in the indicated time frame.
- Karolinska Sleepiness Scale (KSS): [ Time Frame: Administered at baseline and after Day 10 of intervention. ]The KSS is a well-validated, widely used single question survey that examines current sleepiness.
- Adverse Events [ Time Frame: Recorded Day 1-10 of intervention ]Number of adverse events experienced during light therapy
- Inpatient Rehabilitation Therapy Participation [ Time Frame: Collected at baseline and after completion of Day 10 of intervention. ]Participation in rehabilitation therapies will be evaluated at enrollment and again after light therapy (day 13) by the subject's therapist using a 0-100 scale of cooperation with therapy that has been previously utilized in this population.
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): NCT02214212
|United States, Washington|
|Harborview Medical Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Jeanne M Hoffman, PhD||University of Washington|