Feasibility Pilot of Bright Light in the Intensive Care Unit
Circadian Rhythm Sleep Disorder, Unspecified
About this trial
This is an interventional device feasibility trial for Circadian Rhythm Sleep Disorder, Unspecified focused on measuring circadian misalignment, entrainment, zeitgeber, bright light, critical illness
Eligibility Criteria
Inclusion Criteria:
- Hospital admission ≤30 hours at noon on enrollment day
- Expected to say in the Medical Intensive Care Unit ≥24 hours after enrollment
- Age ≥50 years
- History of hypertension based on chart review and presence of 1 or more home blood pressure medications
- Able to understand English
Exclusion Criteria:
At significant risk for pre-existing circadian abnormalities:
- 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
- Home medications include: melatonin, melatonin agonist
- Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
- History of bipolar disease (Bright light therapy possibly unsafe in this population).
- Paralyzed (due to injury, disease or medications)
- Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease
- Homeless
Sites / Locations
- Yale New Haven Hospital, York Street Campus
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Usual care, standard light
10,000 lux bright light, 4 hours
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), but otherwise have usual care.
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.
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.