Yale New Haven Hospital, York Street Campus
New Haven, Connecticut, 06520, United States
NCT Number: NCT03684460
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
New Haven, Connecticut, 06520, United States
To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium. The objective is to conduct a randomized controlled trial to determine if a circadian entrainment intervention, daytime bright light, will promote circadian alignment and reduce days of delirium
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded; patients transferred from the MICU to the floor between 22:00 and 05:00 on subsequent study nights will continue in the study but be excluded from the primary analysis (estimated 10% of patients).
Daytime Bright Light (DBL) will be delivered by a free-standing apparatus set to deliver 10,000 lux. The device will be placed at the bedside within 36 inches of the patient's head and is expected to provide at least 1,250 lux at the angle of gaze. To remain in the study, the patient must be in the Intensive Care Unit (ICU) through 13:00 on day 2 (e.g., the first day of potential intervention). After day 2, DBL and other study activities will continue if the patient is transferred out of the ICU to the general medical floor.
Usual care lighting in ICU.
To remain in the study usual care patients must also remain in the MICU through 13:00 on day 2.
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The primary circadian outcome will be the proportion of daytime activity out of total activity (daytime proportion). Rest-activity patterns will be measured with the Actiwatch Spectrum (Philips Healthcare, Netherlands) set at 30-second epochs and placed on the patient's wrist.
Enrolled patients who do not stay in the MICU through 13:00 of Study Day 2 will be excluded from all analysis.
Time frame: Study Day 1-30 (patients will be censored at hospital discharge)
The approach is to measure days of delirium in our patient cohort. After enrollment, the investigators will check patients daily for delirium until hospital discharge or day 30.
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate.
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The investigators will include additional measures of circadian alignment in our analysis: urinary 6-sulfatoxymelatonin (for patients making sufficient urine and with an indwelling urinary catheter).
Time frame: Study Day 1
Percent of patients/surrogates who agree to bright light when initially described to them.
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Percent of patients who develop eyestrain, headache or visual disturbance (combined outcome).
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Percent of time per day that device delivers the planned dose of light.
Time frame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
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 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The investigators will measure (and control for) the total amount of sleep (sleep quantity) via actigraphy.
Time frame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
The investigators will measure (and control for) overnight sleep efficiency (sleep quality) via actigraphy.
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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