An interventional study of Bright White Light (BWL) and Red Light (RL) in Traumatic Brain Injury, TBI and Sleep, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
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Defined by any of the following:
Post-traumatic amnesia that lasts more than 24 hours.
Exclusion Criteria:
Unable to enroll if any of the following are true
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)
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)
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)
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)
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.
Time frame: Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure
Barrow Neurological Institute Fatigue Scale (BNI-FS)
The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome. The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.
Time frame: At Baseline and After 10 Days of Light Exposure
Functional Independence Measure (FIM) - Motor
Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.
Time frame: 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
The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI. The SDMT was administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research. The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures). Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.
Time frame: Administered at Baseline and After 10 Days of Light Exposure
Positive and Negative Affect Schedule - Positive
The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total positive score, a higher score indicates more positive affect. affect. Scores can range from 10-50 for Positive Affect.
Time frame: Administered at Baseline and After 10 Days of Light Exposure
Positive and Negative Affect Schedule - Negative
The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total negative score, a higher score indicates more negative affect. affect. Scores can range from 10-50 for Negative Affect.
Time frame: Administered at baseline and after 10 days of light exposure
Karolinska Sleepiness Scale (KSS)
The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.
Time frame: Administered at Baseline and after 10 Days of Light Exposure
Makley Scale
The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows: 0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake.
Time frame: 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)
Functional Independence Measure (FIM) - Cognitive
Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.
Time frame: Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)
Cooperation Measure (Therapy Outcome)
Cooperation Measure (Therapy Outcome). Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10 Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.
Time frame: Collected at Baseline and after 10 days of light exposure
| Milestone | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Started | 66 | 65 |
| Completed | 57 | 59 |
| Not completed | 9 | 6 |
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.
| percentage of sleep efficiency (0-100) | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 72 ± 17 | 76 ± 17 |
| After 10 days of light exposure | 76 ± 11 | 77 ± 13 |
The Barrow Neurological Institute Fatigue Scale (BNI-FS; Fatigue Outcome) is an 11-point scale that examines fatigue during acute recovery from TBI. Scores on items 1-10 may range from 1 (rarely a problem), 2-3 (occasional problem but not frequent), 4-5 (a frequent problem), 6-7 (a problem most of the time). The last item is a general rating of fatigue from 0 (not a problem) to 10 (a severe problem). The total BNI-FS is a sum of the first 10 items (0-70), where higher scores indicate worse outcome. The BNI-FS is a scale that was designed to examine fatigue during acute recovery from TBI. The clinical staff involved in the care of these subjects were asked to rate the phototherapy intervention for ease of use, perceived relevance to rehabilitation care, and impression of effectiveness.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 23.7 ± 15.6 | 26.5 ± 14.0 |
| After 10 days of light exposure | 15.6 ± 13.0 | 18.3 ± 16.3 |
Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Motor subscale (the sum of the individual motor subscale items) will be a value between 13 and 91.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| FIM Motor -Rehab Admit | 36.5 ± 18.9 | 38.5 ± 17.3 |
| FIM Motor - Rehab Discharge | 68.2 ± 16.0 | 69.8 ± 12.8 |
The Symbol Digit Modalities Test (SDMT) is a pencil and paper test for attention that takes approximately five minutes to administer and is frequently used in evaluations after TBI. The SDMT was administered at enrollment and after intervention. The Interagency Workgroup on TBI Outcomes selected the SDMT as CORE common data elements in TBI outcomes research. The SDMT measures attention and speed of processing (the test-taker substitutes a number for random presentations of geometric figures). Scoring involves summing the number of correct substitutions within the 90 second interval (min=0, max = 110), with higher scores representing better attention/speed of processing.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 21.3 ± 13.3 | 21.6 ± 12.3 |
| After 10 days light exposure | 25.9 ± 14.4 | 29.0 ± 12.0 |
The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Positive is the sum of the 10 positive items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total positive score, a higher score indicates more positive affect. affect. Scores can range from 10-50 for Positive Affect.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 31.8 ± 9.0 | 30.9 ± 9.3 |
| After 10 Days of Light Exposure | 34.0 ± 8.8 | 34.2 ± 9.0 |
The Positive and Negative Affect Schedule (PANAS; Mood Outcome) includes a total of 20 items of affect with 10 focused on positive affect and 10 focused on negative affect. The total score of the PANAS: Negative is the sum of the 10 negative items which are rated on a likert scale ranging from 1=very slightly or not at all to 5=extremely. For the total negative score, a higher score indicates more negative affect. affect. Scores can range from 10-50 for Negative Affect.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 19.7 ± 8.7 | 19.6 ± 8.2 |
| After 10 days of light exposure | 18.4 ± 8.6 | 17.1 ± 7.2 |
The Karolinska Sleepiness Scale (KSS; Sleepiness Outcome) is a single-question with a 9-point Likert scale (1 = extremely alert, 9 = extremely sleepy, fighting sleep) measuring subjective sleepiness at the time of report.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 4.1 ± 1.8 | 4.1 ± 1.8 |
| After 10 Days of Light Exposure | 4.1 ± 2.0 | 3.7 ± 1.7 |
The Makley scale is a 4-point ordinal scale which allows staff to score sleep as follows: 0 = asleep; 1 = drowsy/falling asleep; 2 = drowsy/waking up; 3 = awake.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 0.58 ± 0.38 | 0.67 ± 0.54 |
| After 10 Days of Light Exposure | 0.59 ± 0.29 | 0.61 ± 0.33 |
Functional Independence Measure (FIM) is the most widely accepted functional assessment measure in use in the rehabilitation community. The FIM is an 18-item ordinal scale, used with all diagnoses within a rehabilitation population. Each item is scored on a 7 point ordinal scale, ranging from a score of 1 to a score of 7. The higher the score, the more independent the patient is in performing the task associated with that item. Cognition subscale (the sum of the individual cognition subscale items) will be a value between 5 and 35.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| FIM Cognitive- Admit | 15.1 ± 6.9 | 14.3 ± 6.3 |
| FIM Cognitive-Discharge | 24.7 ± 5.7 | 24.1 ± 5.1 |
Cooperation Measure (Therapy Outcome). Patient cooperation was rated using a visual analogue scale (VAS) ranging from 0%-not cooperative to 100%- fully cooperative.10 Staff physical therapists were asked to rate cooperation both prior to initiation and after completion of phototherapy.
| score on a scale | Red Light (RL) | Bright White Light (BWL) |
|---|---|---|
| Baseline | 77.3 ± 27.3 | 84.5 ± 22.5 |
| After 10 Days of Light Exposure | 86.6 ± 23.0 | 89.4 ± 22.5 |
Collected over Adverse Event Reporting Period The study period during which adverse events were reported was the period from the initiation of study procedures to the end of the study treatment follow-up. For this study, the study treatment follow-up was 2 days following the last study treatment (Day 15).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Red Light (RL) | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| Bright White Light (BWL) | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Age, Continuous(years) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| Mean | 42.1 ± 2.7 | 39.8 ± 2.6 | 41 ± 2.7 |
| Age, Customized(Participants) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| <25 | 15 | 12 | 27 |
| 25-39 | 15 | 24 | 39 |
| 40-54 | 19 | 15 | 34 |
| 55+ | 17 | 12 | 29 |
| Unknown | 0 | 2 | 2 |
| Sex: Female, Male(Participants) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| Female | 22 | 19 | 41 |
| Male | 44 | 46 | 90 |
| Race/Ethnicity, Customized(Participants) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| White | 43 | 48 | 91 |
| Black | 10 | 6 | 16 |
| Asian/Pacific Islander | 2 | 0 | 2 |
| Native American | 4 | 2 | 6 |
| Hispanic | 5 | 7 | 12 |
| Other | 2 | 0 | 2 |
| Unknown | 0 | 2 | 2 |
| Education(years) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| Mean | 13 ± 2.3 | 14 ± 2.5 | 13.5 ± 2.5 |
| Marital Status(participants) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| Single | 24 | 27 | 51 |
| Married | 25 | 25 | 50 |
| Div/Sep/Widow | 16 | 11 | 27 |
| Unknown | 1 | 2 | 3 |
| Cause of Injury(Participants) | Red Light (RL) | Bright White Light (BWL) | Total |
|---|---|---|---|
| Vehicular | 28 | 42 | 70 |
| Violence | 11 | 3 | 14 |
| Fall | 17 | 13 | 30 |
| Pedestrian | 3 | 6 | 9 |
| Other | 7 | 1 | 8 |
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