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

NCT ID: NCT02214212

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 131 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2017-03-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Red Light (RL)

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.

Group Type: ACTIVE_COMPARATOR

Red Light (RL)

Intervention Type: 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.

Bright White Light (BWL)

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.

Group Type: EXPERIMENTAL

Bright White Light (BWL)

Intervention Type: 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.

Interventions

Bright White Light (BWL)

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.

Intervention Type: DEVICE

Red Light (RL)

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.

Intervention Type: DEVICE

Other Intervention Names

Litebook® (Bright White Light); Litebook® (Red Light)

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: collaborator

University of North Texas Health Science Center

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jeanne Hoffman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeanne M Hoffman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Harborview Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33459040 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY00000219

Identifier Type: -

Identifier Source: org_study_id