Feasibility Pilot of Bright Light in the Intensive Care Unit

Yale University

Status: Completed

Conditions: Circadian Rhythm Sleep Disorder, Unspecified

Treatments: Device: standard light; Device: 10,000 lux bright light, 4 hours; Device: 10,000 lux bright light, 8 hours

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03568045

1R03HL157009-01 (U.S. NIH Grant/Contract)

1K23HL138229-01A1 (U.S. NIH Grant/Contract)

2000022284

Details and patient eligibility

About

To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.

Full description

To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Feasibility will be assessed via the following metrics: daytime bright light is acceptable and tolerable to patients and has high fidelity and sustainability as an intervention.

Enrollment: 16 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Hospital admission ≤30 hours at noon on enrollment day
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

1. 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

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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16 participants in 3 patient groups

Usual care, standard light

Active Comparator group

Description:

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.

Treatment:

Device: standard light

10,000 lux bright light, 4 hours

Experimental group

Description:

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.

Treatment:

Device: 10,000 lux bright light, 4 hours

10,000 lux bright light, 8 hours

Experimental group

Description:

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.

Treatment:

Device: 10,000 lux bright light, 8 hours