Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients

Circadian Rhythm Disorders Clinical Trial

Official title:

Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684460
• Other study ID #: 2000023033
• Secondary ID: 000
• Status: Completed
• Phase: N/A
• Start date: July 8, 2019
• Est. completion date: March 28, 2024

Study information

• Verified date: May 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine if daytime bright light will promote circadian alignment and shorten or prevent delirium.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 28, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Hospital admission =30 hours at noon on enrollment day

2. Expected to say in the Medical Intensive Care Unit (MICU) =24 hours after enrollment

3. Age =50 years

Exclusion Criteria:

1. 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)

• 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 or blind/disease of the optic nerve

• Current history of substance abuse including alcohol (use in last 30 days)

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).

Related Conditions & MeSH terms

• Chronobiology Disorders
• Circadian Rhythm Disorders
• Delirium

Intervention

Device:
• Daytime Bright Light
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 Light
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital, York Street Campus	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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)
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	Feasibility, Patient Acceptance	Percent of patients/surrogates who agree to bright light when initially described to them.	Study Day 1
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).
Secondary	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).