Clinical trial NCT02214212: TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI
Official title: TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
TBI
Sleep
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
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Icahn School of Medicine at Mount Sinai
name: University of North Texas Health Science Center
First posted: 2014-08-12
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Actigraphy Data
timeFrame: Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure
Secondary outcomes:
measure: Barrow Neurological Institute Fatigue Scale (BNI-FS)
timeFrame: At Baseline and After 10 Days of Light Exposure
measure: Functional Independence Measure (FIM) - Motor
timeFrame: Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)
measure: Symbol Digit Modalities Test
timeFrame: Administered at Baseline and After 10 Days of Light Exposure
measure: Positive and Negative Affect Schedule - Positive
timeFrame: Administered at Baseline and After 10 Days of Light Exposure
measure: Positive and Negative Affect Schedule - Negative
timeFrame: Administered at baseline and after 10 days of light exposure
measure: Karolinska Sleepiness Scale (KSS)
timeFrame: Administered at Baseline and after 10 Days of Light Exposure
measure: Makley Scale
timeFrame: A sleep log was 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 after 10 nights of intervention light exposure)
measure: Functional Independence Measure (FIM) - Cognitive
timeFrame: Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)
Other outcomes:
measure: Cooperation Measure (Therapy Outcome)
timeFrame: Collected at Baseline and after 10 days of light exposure
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Jeanne M Hoffman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bell KR, Fogelberg D, Barber J, Nakase-Richardson R, Zumsteg JM, Dubiel R, Dams-O'Connor K, Hoffman JM. The effect of phototherapy on sleep during acute rehabilitation after traumatic brain injury: a randomized controlled trial. Brain Inj. 2021 Jan 18;35(2):180-188. doi: 10.1080/02699052.2021.1871952. Epub 2021 Jan 17.