TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI
Condition: Traumatic Brain Injury; TBI; Sleep
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional

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.
    

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.
    

Intervention name(s): Bright White Light (BWL); Red Light (RL)
Intervention type(s): Device; Device
Intervention description(s): 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.
Other intervention name(s): Litebook® (Bright White Light); Litebook® (Red Light)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: 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