Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients

Yale University

Status: Completed

Conditions: Circadian Rhythm Disorders

Treatments: Device: Usual Light; Device: Daytime Bright Light

Study type: Interventional

Funder types: Other

Identifiers

NCT03684460

2000023033

000

Details and patient eligibility

About

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.

Full description

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. The objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium

Enrollment: 68 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 (MICU) ≥24 hours after enrollment
3. Age ≥50 years

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)
   • 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 or blind/disease of the optic nerve
   • Current history of substance abuse including alcohol (use in last 30 days)

2. Transferred from an outside hospital. 4. History of bipolar disease 5. Paralyzed (due to injury, disease or medications)

Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 2 patient groups

Bright Light

Experimental group

Description:

Intervention: Daytime Bright Light Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 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 09:00 to 13:00 starting on study day 2 and continuing through study day 5 or MICU discharge whichever is longer up to 30 days. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor, if the patient is transferred (prior to study day 5). Feasibility metrics will also be collected.

Treatment:

Device: Daytime Bright Light

Usual Light

Active Comparator group

Description:

Intervention: Usual Care Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 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: Usual Light