Feasibility Pilot of Bright Light in the Intensive Care Unit

NCT03568045 | Completed Results DMC

• 3 other identifiers: 20000222841K23HL138229-01A11R03HL157009-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Circadian Rhythm Sleep Disorder, Unspecified

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light

  Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.

  Study Day 2-5

Secondary Outcomes (4)

• Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described

  Study Day 1 (enrollment)

• Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.

  Study Day 2-5

• Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light

  Study Day 2-5

• Sustainability: Percent of Intended Intervention Days That the Device is Used.

  Study Day 2-5

Study Arms (3)

Usual care, standard light

ACTIVE COMPARATOR

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.

Device: standard light

10,000 lux bright light, 4 hours

EXPERIMENTAL

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.

Device: 10,000 lux bright light, 4 hours

10,000 lux bright light, 8 hours

EXPERIMENTAL

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.

Device: 10,000 lux bright light, 8 hours

Interventions

standard light DEVICE

usual care

Usual care, standard light

10,000 lux bright light, 4 hours DEVICE

Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon.

Also known as: Bright light, 4 hours

10,000 lux bright light, 4 hours

10,000 lux bright light, 8 hours DEVICE

Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm.

Also known as: Bright light, 8 hours

10,000 lux bright light, 8 hours

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 ≥24 hours after enrollment
• Age ≥50 years
• History of hypertension based on chart review and presence of 1 or more home blood pressure medications
• Able to understand English

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) 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
• Home medications include: melatonin, melatonin agonist
• Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
• History of bipolar disease (Bright light therapy possibly unsafe in this population).
• Paralyzed (due to injury, disease or medications)
• Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease
• Homeless

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Critical Illness

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Melissa Knauert
• Organization: Yale School of Medicine

melissa.knauert@yale.edu

203-785-4162

Study Officials

• Melissa Knauert, MD, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Model Details: a pilot randomized control trial of 3 cohort groups.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 26, 2018
• Study Start: December 3, 2018
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: June 17, 2024
• Results First Posted: June 17, 2024

Record last verified: 2024-06

Locations

US (1)