Feasibility Pilot of Bright Light in the Intensive Care Unit

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

Study Overview

• Status: Completed
• Conditions: Circadian Rhythm Sleep Disorder, Unspecified
• Intervention / Treatment: Device: standard light; Device: 10,000 lux bright light, 4 hours; Device: 10,000 lux bright light, 8 hours

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale New Haven Hospital, York Street Campus

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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 Names: Bright light, 8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described	Percent of patients/surrogates who agree to study enrollment including bright light when initially described to them.	Study Day 1 (enrollment)
Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.	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	Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).	Study Day 2-5
Sustainability: Percent of Intended Intervention Days That the Device is Used.	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."	Study Day 2-5

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Melissa Knauert, MD, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: June 21, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): June 17, 2024
• Last Update Submitted That Met QC Criteria: June 14, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: critical illness; entrainment; bright light; circadian misalignment; zeitgeber
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Parasomnias; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: 2000022284; 1K23HL138229-01A1 (U.S. NIH Grant/Contract); 1R03HL157009-01 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• 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