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| Name | Class |
|---|---|
| Washington State University | OTHER |
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The purpose of this study is to assess the safety and efficacy of daily morning exposure to colored light in patients receiving acute inpatient rehabilitation services for stroke, traumatic brain injury, or non-traumatic brain injury with sleep disturbances such as poor nighttime sleep and/or excessive daytime sleepiness.In a two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments, we are comparing the effects of daily morning exposure to either blue light or red light on objective sleep quality, subjective sleep quality, functional rehabilitation outcomes, cognitive symptoms, fatigue, and neurological symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue Light | Active Comparator | Blue light exposure (Philips GoLite Blu HF3429/60) administered daily for 25 minutes between 8:00AM and 9:00AM |
|
| Red Light | Placebo Comparator | Red light exposure (Philips LivingColor Aura 70998/60/48) administered daily for 25 minutes between 8:00AM and 9:00AM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Philips GoLite Blu HF3429/60 | Other | Exposure to daily morning colored light in the 440-485 nm wavelength range |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time | 24/7 recording of total amount of time asleep via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days |
| Sleep Efficiency | Recording of the proportion of time asleep relative to time in bed via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days |
| Sleep Fragmentation Index | Recording of restlessness during a sleep period via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days |
| Frequency of Daytime Naps | Recording of number of naps during daytime via wrist-worn actigraph | From day of consent through study completion at discharge from inpatient rehabilitation, assessed for at least 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Karolinska Sleepiness Scale | Patient-report measure of daytime sleepiness | Baseline and every 3 days plus at study completion, at least 10 days after consent |
| Wits Pictorial Sleepiness Scale | Patient-report measure of daytime sleepiness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Douglas L Weeks, PhD | Contact | 509-473-6000 | weeksdl@st-lukes.org |
| Name | Affiliation | Role |
|---|---|---|
| Douglas L Weeks, PhD | St. Luke's Rehabilitation Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Luke's Rehabilitation Institute | Recruiting | Spokane | Washington | 99202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39510247 | Derived | Weeks DL, Crooks E, O'Brien KE, Sprint G, Carter GT, Honn KA. A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study. Contemp Clin Trials. 2024 Dec;147:107736. doi: 10.1016/j.cct.2024.107736. Epub 2024 Nov 6. |
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two-arm randomized placebo-controlled study with pre-exposure and post-exposure assessments
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| Philips LivingColor Aura 70998/60/48 | Other | Exposure to daily morning colored light in the 625-740 nm wavelength range |
|
| Baseline and every 3 days plus at study completion, at least 10 days after consent |
| Fatigue Visual Analog Scale | Patient-report measure of global fatigue | Baseline and every 3 days plus at study completion, at least 10 days after consent |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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