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

University of Washington

Status: Completed

Conditions: Traumatic Brain Injury; TBI; Sleep

Treatments: Device: Red Light (RL); Device: Bright White Light (BWL)

Study type: Interventional

Funder types: Other

Identifiers

NCT02214212

STUDY00000219

Details and patient eligibility

About

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.

Full 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.

Enrollment: 131 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

131 participants in 2 patient groups

Red Light (RL)

Active Comparator group

Description:

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.

Treatment:

Device: Red Light (RL)

Bright White Light (BWL)

Experimental group

Description:

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.

Treatment:

Device: Bright White Light (BWL)