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

NCT02214212 | Completed Results DMC FDA Device

• 1 other identifier: STUDY00000219
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Actigraphy Data

  Sleep efficiency scores derived from actigraphy data will be the primary outcome. We will set the Actiwatch to record activity data in 60-second intervals. Actigraphy data will be automatically scored with Actiware software (Respironics, Philips Healthcare), which uses validated algorithms to determine whether an epoch of activity is "sleep" or "wake" (Cole RJ, 1992). Typically there is a lack of a consistent sleep/wake cycle in the study population, therefore we will be using sleep efficiency and total sleep time scores obtained during a set night-time interval (2200 to 0600) as the primary index of sleep function, as has been used in previous publications\[39, 40\]. We will be comparing average between group differences between the BWL and RL groups at baseline and after 10 days of light therapy.

  Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure

Secondary Outcomes (8)

• Barrow Neurological Institute Fatigue Scale (BNI-FS)

  At Baseline and After 10 Days of Light Exposure

• Functional Independence Measure (FIM) - Motor

  Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)

• Symbol Digit Modalities Test

  Administered at Baseline and After 10 Days of Light Exposure

• Positive and Negative Affect Schedule - Positive

  Administered at Baseline and After 10 Days of Light Exposure

• Positive and Negative Affect Schedule - Negative

  Administered at baseline and after 10 days of light exposure

Other Outcomes (1)

• Cooperation Measure (Therapy Outcome)

  Collected at Baseline and after 10 days of light exposure

Study Arms (2)

Red Light (RL)

ACTIVE COMPARATOR

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.

Device: Red Light (RL)

Bright White Light (BWL)

EXPERIMENTAL

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.

Device: Bright White Light (BWL)

Interventions

Bright White Light (BWL) DEVICE

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.

Also known as: Litebook® (Bright White Light)

Bright White Light (BWL)

Red Light (RL) DEVICE

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.

Also known as: Litebook® (Red Light)

Red Light (RL)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• Icahn School of Medicine at Mount Sinai: collaborator
• University of North Texas Health Science Center: collaborator

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• 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.

  PMID: 33459040 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Central Nervous System Diseases; Brain Diseases; Nervous System Diseases; Signs and Symptoms

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Results Point of Contact

• Title: Jeanne Hoffman
• Organization: University of Washington

jeanneh@u.washington.edu

2062216511

Study Officials

• Jeanne M Hoffman, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 31, 2014
• First Posted: August 12, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: November 9, 2021
• Results First Posted: November 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)