Feasibility Pilot of Bright Light in the Intensive Care Unit

• ClinicalTrials.gov Identifier: NCT03568045
• Recruitment Status: Enrolling by invitation
• First Posted: June 26, 2018
• Last Update Posted: April 21, 2021
• Sponsor: Yale University
• Information provided by (Responsible Party): Yale University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Circadian Rhythm Sleep Disorder, Unspecified	Device: standard light; Device: 10,000 lux bright light, 4 hours; Device: 10,000 lux bright light, 8 hours	Not Applicable

Detailed Description:

To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Feasibility will be assessed via the following metrics: daytime bright light is acceptable and tolerable to patients and has high fidelity and sustainability as an intervention.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: a pilot randomized control trial of 3 cohort groups.
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Device Feasibility
• Official Title: Feasibility Pilot of Bright Light in the Intensive Care Unit
• Actual Study Start Date: December 3, 2018
• Estimated Primary Completion Date: March 31, 2024
• Estimated Study Completion Date: March 31, 2024

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual care, standard light; 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; usual care
Experimental: 10,000 lux bright light, 4 hours; 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; 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.; Other Name: Bright light, 4 hours
Experimental: 10,000 lux bright light, 8 hours; 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; 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.; Other Name: Bright light, 8 hours

Outcome Measures

Primary Outcome Measures :

1. Tolerance (time): Percent of intended treatment hours that patient continues with the delivery of bright light [ Time Frame: Study Day 2-5 ]
   Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.

Secondary Outcome Measures :

1. Acceptance: Percent of patients/surrogates who agree to bright light when initially described [ Time Frame: Study Day 1 (enrollment) ]
   Percent of patients/surrogates who agree to bright light when initially described to them.
2. Tolerance (symptoms): Percent of patients who develop eye strain, headache or visual disturbance. [ Time Frame: Study Day 2-5 ]
   Percent of patients who develop eye strain, headache or visual disturbance.
3. Fidelity: Percent of time per day that device delivers the planned dose of light [ Time Frame: Study Day 2-5 ]
   Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).
4. Sustainability: Percent of intended intervention days that the device is used. [ Time Frame: Study Day 2-5 ]
   Percent of intended intervention days that the device is used. For this metric, days that the patient refuses bright light will not be included in "intended intervention days."

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Hospital admission ≤30 hours at noon on enrollment day
2. Expected to say in the Medical Intensive Care Unit ≥24 hours after enrollment
3. Age ≥50 years
4. History of hypertension based on chart review and presence of 1 or more home blood pressure medications
5. Able to understand English

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

Contacts and Locations

Locations

United States, Connecticut

Yale New Haven Hospital, York Street Campus

New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Investigators

• Principal Investigator: Melissa Knauert, MD, PhD; Yale University

More Information

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03568045
• Other Study ID Numbers: 2000022284
• First Posted: June 26, 2018
• Last Update Posted: April 21, 2021
• Last Verified: April 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Yale University:

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

Additional relevant MeSH terms:

Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm; Nervous System Diseases; Neurologic Manifestations; Mental Disorders; Chronobiology Disorders; Dyssomnias; Occupational Diseases