TWILIGHT Study: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI
| Status: | Completed |
|---|---|
| Conditions: | Insomnia Sleep Studies, Hospital, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/25/2017 |
| Start Date: | December 2013 |
| End Date: | March 2017 |
TWILIGHT: Effect of Light Exposure During Acute Rehabilitation on Sleep After TBI.
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.
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.
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.
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)
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