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

NCT03684460 | Completed DMC

• 2 other identifiers: 2000023033000
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Circadian Rhythm Disorders

Keywords

circadian misalignment; bright light; entrainment; zeitgeber; critical illness; delirium; actigraphy

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (10)

• Circadian Alignment, Secondary Measures, Body surface temperature gradient

  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

  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.

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

• Feasibility, Patient Acceptance

  Study Day 1

• Feasibility, Patient Tolerance Time

  Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Study Arms (2)

Bright Light

EXPERIMENTAL

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.

Device: Daytime Bright Light

Usual Light

ACTIVE COMPARATOR

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.

Device: Usual Light

Interventions

Daytime Bright Light DEVICE

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.

Bright Light

Usual Light DEVICE

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.

Usual Light

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospital admission ≤30 hours at noon on enrollment day
• Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
• Age ≥50 years

You may not qualify if:

• 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)
• \. 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).

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Chronobiology Disorders; Critical Illness; Delirium

Condition Hierarchy (Ancestors)

Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Melissa Knauert, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized controlled trial with 2 cohorts

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: September 25, 2018
• Study Start: July 8, 2019
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Locations

US (1)