Trial Outcomes & Findings for TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI (NCT NCT02214212)
NCT ID: NCT02214212
Last Updated: 2021-11-09
Results Overview
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.
COMPLETED
NA
131 participants
Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposure
2021-11-09
Participant Flow
Participant milestones
| Measure |
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.
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.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
65
|
|
Overall Study
COMPLETED
|
57
|
59
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI
Baseline characteristics by cohort
| Measure |
Red Light (RL)
n=66 Participants
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.
|
Bright White Light (BWL)
n=65 Participants
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
n=131 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.1 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 2.6 • n=7 Participants
|
41 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Age, Customized
<25
|
15 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Age, Customized
25-39
|
15 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Age, Customized
40-54
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Customized
55+
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Customized
Unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Education
|
13 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
14 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
13.5 years
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Marital Status
Single
|
24 participants
n=5 Participants
|
27 participants
n=7 Participants
|
51 participants
n=5 Participants
|
|
Marital Status
Married
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
|
Marital Status
Div/Sep/Widow
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Marital Status
Unknown
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Cause of Injury
Vehicular
|
28 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Cause of Injury
Violence
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Cause of Injury
Fall
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Cause of Injury
Pedestrian
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Cause of Injury
Other
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Average percent sleep efficiency (0-100) at baseline and after 10 days of light exposurePopulation: 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.
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.
Outcome measures
| Measure |
Red Light (RL)
n=57 Participants
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.
|
Bright White Light (BWL)
n=60 Participants
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.
|
|---|---|---|
|
Actigraphy Data
Baseline
|
72 percentage of sleep efficiency (0-100)
Standard Deviation 17
|
76 percentage of sleep efficiency (0-100)
Standard Deviation 17
|
|
Actigraphy Data
After 10 days of light exposure
|
76 percentage of sleep efficiency (0-100)
Standard Deviation 11
|
77 percentage of sleep efficiency (0-100)
Standard Deviation 13
|
SECONDARY outcome
Timeframe: At Baseline and After 10 Days of Light ExposurePopulation: 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%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=55 Participants
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.
|
Bright White Light (BWL)
n=61 Participants
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.
|
|---|---|---|
|
Barrow Neurological Institute Fatigue Scale (BNI-FS)
After 10 days of light exposure
|
15.6 score on a scale
Standard Deviation 13.0
|
18.3 score on a scale
Standard Deviation 16.3
|
|
Barrow Neurological Institute Fatigue Scale (BNI-FS)
Baseline
|
23.7 score on a scale
Standard Deviation 15.6
|
26.5 score on a scale
Standard Deviation 14.0
|
SECONDARY outcome
Timeframe: Administered at baseline (admission to unit) and after Day 10 of intervention (or at the day of discharge from the rehabilitation unit)Population: 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.
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.
Outcome measures
| Measure |
Red Light (RL)
n=62 Participants
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.
|
Bright White Light (BWL)
n=62 Participants
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.
|
|---|---|---|
|
Functional Independence Measure (FIM) - Motor
FIM Motor - Rehab Discharge
|
68.2 score on a scale
Standard Deviation 16.0
|
69.8 score on a scale
Standard Deviation 12.8
|
|
Functional Independence Measure (FIM) - Motor
FIM Motor -Rehab Admit
|
36.5 score on a scale
Standard Deviation 18.9
|
38.5 score on a scale
Standard Deviation 17.3
|
SECONDARY outcome
Timeframe: Administered at Baseline and After 10 Days of Light ExposurePopulation: Of the overall enrollment number of 131 participants, we were able to obtain completed data for this measure on 79 participants (or 60%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=39 Participants
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.
|
Bright White Light (BWL)
n=40 Participants
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.
|
|---|---|---|
|
Symbol Digit Modalities Test
After 10 days light exposure
|
25.9 score on a scale
Standard Error 14.4
|
29.0 score on a scale
Standard Error 12.0
|
|
Symbol Digit Modalities Test
Baseline
|
21.3 score on a scale
Standard Error 13.3
|
21.6 score on a scale
Standard Error 12.3
|
SECONDARY outcome
Timeframe: Administered at Baseline and After 10 Days of Light ExposurePopulation: Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 118 participants (or 90%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=57 Participants
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.
|
Bright White Light (BWL)
n=61 Participants
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.
|
|---|---|---|
|
Positive and Negative Affect Schedule - Positive
After 10 Days of Light Exposure
|
34.0 score on a scale
Standard Deviation 8.8
|
34.2 score on a scale
Standard Deviation 9.0
|
|
Positive and Negative Affect Schedule - Positive
Baseline
|
31.8 score on a scale
Standard Deviation 9.0
|
30.9 score on a scale
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Administered at baseline and after 10 days of light exposurePopulation: Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 119 participants (or 91%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=58 Participants
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.
|
Bright White Light (BWL)
n=61 Participants
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.
|
|---|---|---|
|
Positive and Negative Affect Schedule - Negative
After 10 days of light exposure
|
18.4 score on a scale
Standard Deviation 8.6
|
17.1 score on a scale
Standard Deviation 7.2
|
|
Positive and Negative Affect Schedule - Negative
Baseline
|
19.7 score on a scale
Standard Deviation 8.7
|
19.6 score on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: Administered at Baseline and after 10 Days of Light ExposurePopulation: Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 121 participants (or 92%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=59 Participants
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.
|
Bright White Light (BWL)
n=62 Participants
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.
|
|---|---|---|
|
Karolinska Sleepiness Scale (KSS)
Baseline
|
4.1 score on a scale
Standard Deviation 1.8
|
4.1 score on a scale
Standard Deviation 1.8
|
|
Karolinska Sleepiness Scale (KSS)
After 10 Days of Light Exposure
|
4.1 score on a scale
Standard Deviation 2.0
|
3.7 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
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)Population: 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%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=57 Participants
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.
|
Bright White Light (BWL)
n=60 Participants
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.
|
|---|---|---|
|
Makley Scale
After 10 Days of Light Exposure
|
0.59 score on a scale
Standard Deviation 0.29
|
0.61 score on a scale
Standard Deviation 0.33
|
|
Makley Scale
Baseline
|
0.58 score on a scale
Standard Deviation 0.38
|
0.67 score on a scale
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: Administered at baseline (admission to unit) and after Day 10 of light exposure (or at the day of discharge from the rehabilitation unit)Population: Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 124 participants (or 95%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=62 Participants
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.
|
Bright White Light (BWL)
n=62 Participants
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.
|
|---|---|---|
|
Functional Independence Measure (FIM) - Cognitive
FIM Cognitive- Admit
|
15.1 score on a scale
Standard Deviation 6.9
|
14.3 score on a scale
Standard Deviation 6.3
|
|
Functional Independence Measure (FIM) - Cognitive
FIM Cognitive-Discharge
|
24.7 score on a scale
Standard Deviation 5.7
|
24.1 score on a scale
Standard Deviation 5.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Collected at Baseline and after 10 days of light exposurePopulation: Of the overall enrollment number of 131, we were able to obtain completed data for this measure on 123 participants (or 94%).
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.
Outcome measures
| Measure |
Red Light (RL)
n=60 Participants
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.
|
Bright White Light (BWL)
n=63 Participants
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.
|
|---|---|---|
|
Cooperation Measure (Therapy Outcome)
After 10 Days of Light Exposure
|
86.6 score on a scale
Standard Deviation 23.0
|
89.4 score on a scale
Standard Deviation 22.5
|
|
Cooperation Measure (Therapy Outcome)
Baseline
|
77.3 score on a scale
Standard Deviation 27.3
|
84.5 score on a scale
Standard Deviation 22.5
|
Adverse Events
Red Light (RL)
Bright White Light (BWL)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place