At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.
In Brief
A clinical study evaluating Bright White Light (BWL) and Red Light (RL) for Traumatic Brain Injury and 2 related conditions. Completed, enrolled 131 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.