Status:
COMPLETED
TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI
Lead Sponsor:
University of Washington
Collaborating Sponsors:
Icahn School of Medicine at Mount Sinai
University of North Texas Health Science Center
Conditions:
Traumatic Brain Injury
TBI
Eligibility:
All Genders
18-70 years
Phase:
NA
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 o...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
131 Patients enrolled
Trial Details
Trial ID
NCT02214212
Start Date
December 1 2013
End Date
March 1 2017
Last Update
November 9 2021
Active Locations (1)
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1
Harborview Medical Center
Seattle, Washington, United States, 98109