Feasibility Pilot of Bright Light in the Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.

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.

Official Title
-----------------
Feasibility Pilot of Bright Light in the Intensive Care Unit

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a pilot randomized control trial of 3 cohort groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care, standard light<br>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<br>* usual care<br>|
| Experimental: 10,000 lux bright light, 4 hours<br>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<br>* 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.<br>* Other names: Bright light, 4 hours;|
| Experimental: 10,000 lux bright light, 8 hours<br>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<br>* 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.<br>* 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 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
circadian misalignment, entrainment, zeitgeber, bright light, critical illness