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TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI (TWILIGHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02214212
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : November 24, 2017
Sponsor:
Collaborators:
Icahn School of Medicine at Mount Sinai
University of North Texas Health Science Center
Information provided by (Responsible Party):
Jeanne Hoffman, University of Washington

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury TBI Sleep Device: Bright White Light (BWL) Device: Red Light (RL) Not Applicable

Detailed Description:
The investigators will recruit persons with moderate to severe traumatic brain injury (TBI) on admission to intensive rehabilitation units. Consented participants (who meet all inclusion and exclusion criteria) will wear an actigraphy watch for 2 nights to obtain a baseline for sleep pattern identification. Prior to treatment, baseline measures (detailed below) will be obtained. Participants will be randomized to receive either Bright White Light (BWL) or Red Light (RL) treatment. Light therapy treatments will be given for 30 minutes daily in the morning for 10 days, and an Actiwatch will be worn continuously during that period. At the end of 10 days, outcome measures will be obtained (as below). The specific period of treatment may be affected by the length of stay on the rehabilitation unit. For lengths of stay less than the 10 days, subjects will receive the intervention until the day of discharge at which time the outcome measures will be administered. The investigators primary outcome measure with be the actigraphic measurement of sleep efficiency. Other secondary measures will be participation in therapy, sleepiness, and attention. The investigators will also evaluate the anticipated device costs and clinical staff burden involved in utilizing light therapy exposure in an inpatient rehabilitation clinical setting.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

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.

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)

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.

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)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. Adverse Events [ Time Frame: Recorded Day 1-10 of intervention ]
    Number of adverse events experienced during light therapy


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have experienced a moderate to severe TBI.

Defined by any of the following:

  1. Loss of Consciousness greater than 30 minutes.
  2. Emergency Room admission with a Glasgow Coma Scale of 12 or below.
  3. Intracranial abnormalities on imaging.
  4. 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)

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): NCT02214212


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
Icahn School of Medicine at Mount Sinai
University of North Texas Health Science Center
Investigators
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Principal Investigator: Jeanne M Hoffman, PhD University of Washington

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Responsible Party: Jeanne Hoffman, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02214212    
Other Study ID Numbers: STUDY00000219
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Jeanne Hoffman, University of Washington:
traumatic brain injury
TBI
Sleep
Bright White Light Therapy
Red Light Therapy
Recovery
Central Nervous System Diseases
Brain Diseases
Nervous System Diseases
Signs and Symptoms
Rehabilitation
Actigraphy
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries