Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, 06520, United States
NCT Number: NCT03568045
To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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 4pm.
Other names: Bright light, 8 hours
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.
Time frame: Study Day 1 (enrollment)
Percent of patients/surrogates who agree to study enrollment including bright light when initially described to them.
Time frame: Study Day 2-5
Percent of patients who develop eye strain, headache or visual disturbance.
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).
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."
Yale University
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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