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

Not Applicable

Completed

• Conditions: Circadian Rhythm Disorders
• Interventions: Device: Daytime Bright Light; Device: Usual Light

• Registration Number: NCT03684460
• Lead Sponsor: Yale University

Brief Summary

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

Detailed 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

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-09-21
• Study First Posted: 2018-09-25
• Study Start: 2019-07-08
• Primary Completion: 2024-03-28
• Study Completion: 2024-03-28
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-21
• Last Update Posted: 2024-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

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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)

2. 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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright Light	Daytime Bright Light	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.
Usual Light	Usual Light	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.

Primary Outcome Measures

Name	Time	Method
Days of Delirium	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.
Circadian Alignment	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.

Secondary Outcome Measures

Name	Time	Method
Circadian Alignment, Secondary Measures, Continous Heart Rate	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.
Feasibility, Patient Tolerance Time	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.
Feasibility, Patient Tolerance Symptoms	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).
Sleep Efficiency	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.
Circadian Alignment, Secondary Measures, 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).	The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.
Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.	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).
Feasibility, Intervention Fidelity	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.
Feasibility, Intervention Sustainability	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."
Total Sleep	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.
Feasibility, Patient Acceptance	Study Day 1	Percent of patients/surrogates who agree to bright light when initially described to them.

Trial Locations

Locations (1)

Yale New Haven Hospital, York Street Campus; 🇺🇸 New Haven, Connecticut, United States