N/A Completed N=131 Randomized Triple-blind Treatment

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

Traumatic Brain Injury · TBI · Sleep

Source: ClinicalTrials.gov NCT02214212 ↗

Enrolled (actual)

131

Serious AEs

0.0%

Results posted

Nov 2021

Primary outcomePrimary: Actigraphy Data — 72; 76; 76; 77 percentage of sleep efficiency (0-100) — p=.955

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Actigraphy Data	72; 76; 76; 77	.955
SECONDARY Barrow Neurological Institute Fatigue Scale (BNI-FS)	23.7; 26.5; 15.6; 18.3	.807
SECONDARY Functional Independence Measure (FIM) - Motor	36.5; 38.5; 68.2; 69.8	.847
SECONDARY Symbol Digit Modalities Test	21.3; 21.6; 25.9; 29.0	.252
SECONDARY Positive and Negative Affect Schedule - Positive	31.8; 30.9; 34.0; 34.2	.722
SECONDARY Positive and Negative Affect Schedule - Negative	19.7; 19.6; 18.4; 17.1	.253
SECONDARY Karolinska Sleepiness Scale (KSS)	4.1; 4.1; 4.1; 3.7	.351
SECONDARY Makley Scale	0.58; 0.67; 0.59; 0.61	.910
SECONDARY Functional Independence Measure (FIM) - Cognitive	15.1; 14.3; 24.7; 24.1	0.19

Eligibility Criteria

Inclusion Criteria

Have experienced a moderate to severe TBI.

Defined by any of the following:

Loss of Consciousness greater than 30 minutes.
Emergency Room admission with a Glasgow Coma Scale of 12 or below.
Intracranial abnormalities on imaging.
Post-traumatic amnesia that lasts more than 24 hours.
Admitted to acute inpatient rehabilitation unit at Harborview Medical Center within 3 months of their Traumatic Brain Injury.
Able to communicate in English.
Between the ages of 18 and 70 years old
Have a clinician rating of the presence of a sleep disturbance (using the Makley scale)
Have some vision in one or both eyes.
Have a Body Mass Index lower than 40 kg/m2

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)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02214212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.