Feasibility Pilot of Bright Light in the Intensive Care Unit
NCT ID: NCT03568045
Last Updated: 2024-06-17
Study Results
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View full resultsBasic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2018-12-03
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DEVICE_FEASIBILITY
SINGLE
Study Groups
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Usual care, standard light
Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), but otherwise have usual care.
standard light
usual care
10,000 lux bright light, 4 hours
Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), starting on study day 1. Patients will be exposed to bright light from 8am to noon starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred.
Feasibility metrics will be collected.
10,000 lux bright light, 4 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon.
10,000 lux bright light, 8 hours
Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am on the prior calendar day). Enrollment will occur before noon, and the day of enrollment is termed study day 1.
Patients will undergo monitoring (light levels, circadian alignment), starting on study day 1. Patients will be exposed to bright light from 8am to 4pm starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred.
Feasibility metrics will be collected.
10,000 lux bright light, 8 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm.
Interventions
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standard light
usual care
10,000 lux bright light, 4 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon.
10,000 lux bright light, 8 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Expected to say in the Medical Intensive Care Unit ≥24 hours after enrollment
3. Age ≥50 years
4. History of hypertension based on chart review and presence of 1 or more home blood pressure medications
5. Able to understand English
Exclusion Criteria
* Severe chronic brain injury (Injury greater than 30 days ago resulting in the inability to live independently) OR Acute brain injury of any severity (Injury less than 30 days ago including acute intracranial bleed, traumatic brain injury, central nervous system infection, tumor)
* Documented circadian disorder (\<1% population) or blind/disease of the optic nerve
* Current history of substance abuse including alcohol (use in last 30 days)
* Current or recent (last 1 year) shiftwork
2. Home medications include: melatonin, melatonin agonist
3. Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
4. History of bipolar disease (Bright light therapy possibly unsafe in this population).
5. Paralyzed (due to injury, disease or medications)
6. Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease
7. Homeless
50 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Melissa Knauert, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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