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| ID | Type | Description | Link |
|---|---|---|---|
| 000 | Other Identifier | CTGTY |
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To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bright Light | Experimental | Intervention: Daytime Bright Light Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 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 09:00 to 13:00 starting on study day 2 and continuing through study day 5 or MICU discharge whichever is longer up to 30 days. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor, if the patient is transferred (prior to study day 5). Feasibility metrics will also be collected. |
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| Usual Light | Active Comparator | Intervention: Usual Care Patients will be eligible if they were admitted within 30 hours of noon on enrollment day (e.g. at or after 06:00 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Daytime Bright Light | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Alignment | 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. | Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Days of Delirium | 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. | Study Day 1-30 (patients will be censored at hospital discharge) |
| Measure | Description | Time Frame |
|---|---|---|
| Circadian Alignment, Secondary Measures, Body surface temperature gradient | The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient. | Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
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Inclusion Criteria:
Exclusion Criteria:
At significant risk for pre-existing circadian abnormalities:
3. Transferred from an outside hospital. 4. History of bipolar disease 5. Paralyzed (due to injury, disease or medications)
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).
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Knauert, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital, York Street Campus | New Haven | Connecticut | 06520 | United States |
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| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D016638 | Critical Illness |
| D003693 | Delirium |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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randomized controlled trial with 2 cohorts
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| Usual Light | Device | 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. |
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| Circadian Alignment, Secondary Measures, Continous Heart Rate |
The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate. |
| Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin. | 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). | Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Feasibility, Patient Acceptance | Percent of patients/surrogates who agree to bright light when initially described to them. | Study Day 1 |
| Feasibility, Patient Tolerance Time | Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light. | Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Feasibility, Patient Tolerance Symptoms | Percent of patients who develop eyestrain, headache or visual disturbance (combined outcome). | Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Feasibility, Intervention Fidelity | Percent of time per day that device delivers the planned dose of light. | Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Feasibility, Intervention Sustainability | 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 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Total Sleep | The investigators will measure (and control for) the total amount of sleep (sleep quantity) via actigraphy. | Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| Sleep Efficiency | The investigators will measure (and control for) overnight sleep efficiency (sleep quality) via actigraphy. | Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge). |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |