To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
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
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
16
usual care
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.
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.
Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, United States
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.
Time frame: Study Day 2-5
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.
Time frame: 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.
Time frame: 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).
Time frame: 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."
Time frame: Study Day 2-5
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