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

Yale University68 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Circadian Rhythm Disorders

Interventions

Daytime Bright LightDEVICE

Daytime Bright Light (DBL) will be delivered by a free-standing apparatus set to deliver 10,000 lux. The device will be placed at the bedside within 36 inches of the patient's head and is expected to provide at least 1,250 lux at the angle of gaze. To remain in the study, the patient must be in the Intensive Care Unit (ICU) through 13:00 on day 2 (e.g., the first day of potential intervention). After day 2, DBL and other study activities will continue if the patient is transferred out of the ICU to the general medical floor.

Usual LightDEVICE

Usual care lighting in ICU. To remain in the study usual care patients must also remain in the MICU through 13:00 on day 2.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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) 3\. 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).

Locations (1)

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Circadian Alignment

The primary circadian outcome will be the proportion of daytime activity out of total activity (daytime proportion). Rest-activity patterns will be measured with the Actiwatch Spectrum (Philips Healthcare, Netherlands) set at 30-second epochs and placed on the patient's wrist. Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded from all analysis.

Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Days of Delirium

The approach is to measure days of delirium in our patient cohort. After enrollment, the investigators will check patients daily for delirium until hospital discharge or day 30.

Time frame: Study Day 1-30 (patients will be censored at hospital discharge)

Secondary Outcomes

Circadian Alignment, Secondary Measures, Body surface temperature gradient

The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.

Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Circadian Alignment, Secondary Measures, Continous Heart Rate

The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate.

Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.

The investigators will include additional measures of circadian alignment in our analysis: urinary 6-sulfatoxymelatonin (for patients making sufficient urine and with an indwelling urinary catheter).

Data from ClinicalTrials.gov

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