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

NCT ID: NCT03684460

Last Updated: 2024-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-08
• Study Completion Date: 2024-03-28

Brief Summary

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

Detailed 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

Conditions

Circadian Rhythm Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Bright Light

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.

Group Type: EXPERIMENTAL

Daytime Bright Light

Intervention Type: 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.

Usual Light

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.

Group Type: ACTIVE_COMPARATOR

Usual Light

Intervention Type: 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.

Interventions

Daytime Bright Light

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.

Intervention Type: DEVICE

Usual Light

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.

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Knauert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

000

Identifier Type: OTHER

Identifier Source: secondary_id

2000023033

Identifier Type: -

Identifier Source: org_study_id