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

• Sponsor: University of Washington (Other)
• Overall Status: Completed
• CT.gov ID: NCT02214212
• Collaborator: Icahn School of Medicine at Mount Sinai (Other), University of North Texas Health Science Center (Other)
• Enrollment: 131
• Location: 1
• Arms: 2
• Actual Duration (Months): 39
• Patients Per Site Per Month: 3.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury; TBI; Sleep	Device: Bright White Light (BWL); Device: Red Light (RL)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 131 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.
• Actual Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Mar 1, 2017
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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.; Other Names: Litebook® (Red Light)
Experimental: 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.	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.; Other Names: Litebook® (Bright White Light)

Outcome Measures

Primary Outcome Measures

1. Actigraphy Data [Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure]

   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.

Secondary Outcome Measures

1. Barrow Neurological Institute Fatigue Scale (BNI-FS) [At Baseline and After 10 Days of Light Exposure]

   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.

2. 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)]

   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.

3. Symbol Digit Modalities Test [Administered at Baseline and After 10 Days of Light Exposure]

   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.

4. Positive and Negative Affect Schedule - Positive [Administered at Baseline and After 10 Days of Light Exposure]

   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.

5. Positive and Negative Affect Schedule - Negative [Administered at baseline and after 10 days of light exposure]

   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.

6. Karolinska Sleepiness Scale (KSS) [Administered at Baseline and after 10 Days of Light Exposure]

   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.

7. Makley Scale [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)]

   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.

8. Functional Independence Measure (FIM) - Cognitive [Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)]

   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.

Other Outcome Measures

1. Cooperation Measure (Therapy Outcome) [Collected at Baseline and after 10 days of light exposure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Harborview Medical Center	Seattle	Washington	United States	98109

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Jeanne M Hoffman, PhD, University of Washington

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Sep 2, 2014

More Information

Publications

None provided.

• Responsible Party: Jeanne Hoffman, Professor, University of Washington
• ClinicalTrials.gov Identifier: NCT02214212
• Other Study ID Numbers: STUDY00000219
• First Posted: Aug 12, 2014
• Last Update Posted: Nov 9, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Jeanne Hoffman, Professor, University of Washington: 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
• Additional relevant MeSH terms: Brain Injuries; Brain Injuries, Traumatic

Study Results

Participant Flow

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/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. 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/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. 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.
Period Title: Overall Study
STARTED	66	65
COMPLETED	57	59
NOT COMPLETED	9	6

Baseline Characteristics

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)	Total
Arm/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. 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/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. 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.	Total of all reporting groups
Overall Participants	66	65	131
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	42.1 (2.7)	39.8 (2.6)	41 (2.7)
Age, Customized (Count of Participants)
<25	15 22.7%	12 18.5%	27 20.6%
25-39	15 22.7%	24 36.9%	39 29.8%
40-54	19 28.8%	15 23.1%	34 26%
55+	17 25.8%	12 18.5%	29 22.1%
Unknown	0 0%	2 3.1%	2 1.5%
Sex: Female, Male (Count of Participants)
Female	22 33.3%	19 29.2%	41 31.3%
Male	44 66.7%	46 70.8%	90 68.7%
Race/Ethnicity, Customized (Count of Participants)
White	43 65.2%	48 73.8%	91 69.5%
Black	10 15.2%	6 9.2%	16 12.2%
Asian/Pacific Islander	2 3%	0 0%	2 1.5%
Native American	4 6.1%	2 3.1%	6 4.6%
Hispanic	5 7.6%	7 10.8%	12 9.2%
Other	2 3%	0 0%	2 1.5%
Unknown	0 0%	2 3.1%	2 1.5%
Education (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	13 (2.3)	14 (2.5)	13.5 (2.5)
Marital Status (participants) [Number]
Single	24 36.4%	27 41.5%	51 38.9%
Married	25 37.9%	25 38.5%	50 38.2%
Div/Sep/Widow	16 24.2%	11 16.9%	27 20.6%
Unknown	1 1.5%	2 3.1%	3 2.3%
Cause of Injury (Number) [Number]
Vehicular	28 42.4%	42 64.6%	70 53.4%
Violence	11 16.7%	3 4.6%	14 10.7%
Fall	17 25.8%	13 20%	30 22.9%
Pedestrian	3 4.5%	6 9.2%	9 6.9%
Other	7 10.6%	1 1.5%	8 6.1%

Outcome Measures

1. Primary Outcome

Title	Actigraphy Data
Description	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

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 117 (or 89%) and a breakdown between groups for light exposure of 57=Red Light and 60=Bright White Light.

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	The Red Light group was exposed to RL (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	57	60
Baseline	72 (17)	76 (17)
After 10 days of light exposure	76 (11)	77 (13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.955
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects.
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	-0.16
	Confidence Interval	(2-Sided) 95%; -5.69 to 5.37
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reported effect size has been expressed as the modelled difference in sleep efficiency improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.

2. Secondary Outcome

Title	Barrow Neurological Institute Fatigue Scale (BNI-FS)
Description	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

Outcome Measure Data

Analysis Population Description

Statistical significance by mixed-effects regression adjusting for site, FIM admit cognitive, FIM admit motor. (Incident and education did not improve any of the models.) Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 116 (or 88%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	The Red Light group was exposed to RL (comparator) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	55	61
Baseline	23.7 (15.6)	26.5 (14.0)
After 10 days of light exposure	15.6 (13.0)	18.3 (16.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.807
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.69
	Confidence Interval	(2-Sided) 95%; -4.90 to 6.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Functional Independence Measure (FIM) - Motor
Description	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)

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 124 (or 95%). The Functional Independence Measure (FIM) was completed at Rehab Admit and again at Rehab Discharge.

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/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. 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/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. 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.
Measure Participants	62	62
FIM Motor -Rehab Admit	36.5 (18.9)	38.5 (17.3)
FIM Motor - Rehab Discharge	68.2 (16.0)	69.8 (12.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.847
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.48
	Confidence Interval	(2-Sided) 95%; -5.38 to 4.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Symbol Digit Modalities Test
Description	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

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 79 participants (or 60%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	The Red Light group was exposed to RL (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	The intervention group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	39	40
Baseline	21.3 (13.3)	21.6 (12.3)
After 10 days light exposure	25.9 (14.4)	29.0 (12.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.252
	Comments
	Method	Mixed Models Analysis
	Comments	Statistical significance by mixed-effects regression adjusts for time (pre/post), site, FIM admit cognitive, FIM admit motor as fixed effects.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	3.14
	Confidence Interval	(2-Sided) 95%; -2.29 to 8.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Positive and Negative Affect Schedule - Positive
Description	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

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 118 participants (or 90%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	57	61
Baseline	31.8 (9.0)	30.9 (9.3)
After 10 Days of Light Exposure	34.0 (8.8)	34.2 (9.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.722
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95%; -3.08 to 4.4
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Positive and Negative Affect Schedule - Negative
Description	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

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 119 participants (or 91%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	58	61
Baseline	19.7 (8.7)	19.6 (8.2)
After 10 days of light exposure	18.4 (8.6)	17.1 (7.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.253
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-2.25
	Confidence Interval	(2-Sided) 95%; -6.13 to 1.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Karolinska Sleepiness Scale (KSS)
Description	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

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 121 participants (or 92%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	59	62
Baseline	4.1 (1.8)	4.1 (1.8)
After 10 Days of Light Exposure	4.1 (2.0)	3.7 (1.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.351
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects model adjusts for treatment, time (pre/post), site, FIM admit cognitive/motor, and the treatment/time as fixed effects.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.39
	Confidence Interval	(2-Sided) 95%; -1.21 to 0.44
	Parameter Dispersion	Type: Value:
	Estimation Comments	A positive effect size indicates a higher score in the bright white light (BWL) intervention arm.

8. Secondary Outcome

Title	Makley Scale
Description	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)

Outcome Measure Data

Analysis Population Description

1:1 comparison; Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 117 participants (or 89%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/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. 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/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. 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.
Measure Participants	57	60
Baseline	0.58 (0.38)	0.67 (0.54)
After 10 Days of Light Exposure	0.59 (0.29)	0.61 (0.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.910
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects model used an unstructured correlation matrix, adjusting for treatment, time (linear) and the interaction as fixed effects
Method of Estimation	Estimation Parameter	Slope
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 95%; -0.03 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments	The reported effect size has been expressed as the modelled difference in the Makley scale score improvement from day 1 to day 10. A positive effect size indicates a higher score in the white-light arm.

9. Secondary Outcome

Title	Functional Independence Measure (FIM) - Cognitive
Description	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)

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 124 participants (or 95%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/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. 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/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. 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.
Measure Participants	62	62
FIM Cognitive- Admit	15.1 (6.9)	14.3 (6.3)
FIM Cognitive-Discharge	24.7 (5.7)	24.1 (5.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.19
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects model adjusts for treatment time (pre/post)
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	.857
	Confidence Interval	(2-Sided) 95%; -1.93 to 2.32
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Other Pre-specified Outcome

Title	Cooperation Measure (Therapy Outcome)
Description	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

Outcome Measure Data

Analysis Population Description

Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 123 participants (or 94%).

Arm/Group Title	Red Light (RL)	Bright White Light (BWL)
Arm/Group Description	This group was exposed to Red Light (RL) (control) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.	This group was exposed to BWL (active treatment) for 30 minutes each morning between 0730 and 0930 for up to 10 days. Both interventions were delivered using a Litebook® with visually identical cases.
Measure Participants	60	63
Baseline	77.3 (27.3)	84.5 (22.5)
After 10 Days of Light Exposure	86.6 (23.0)	89.4 (22.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Red Light (RL), Bright White Light (BWL)
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.345
	Comments
	Method	Mixed Models Analysis
	Comments	Mixed-effects model adjusts for treatment, time (pre/post), FIM admit cognitive, site, FIM admit motor as mixed effects.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.80
	Confidence Interval	(2-Sided) 95%; -14.83 to 5.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	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).
Arm/Group Title	Red Light (RL)		Bright White Light (BWL)
Arm/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. 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/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. 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.
All Cause Mortality
	Red Light (RL)		Bright White Light (BWL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/65 (0%)
Serious Adverse Events
	Red Light (RL)		Bright White Light (BWL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/65 (0%)
Other (Not Including Serious) Adverse Events
	Red Light (RL)		Bright White Light (BWL)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/66 (0%)		0/65 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.