Clinical trial NCT03684460: Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients
Official title: Daytime Bright Light, Circadian Abnormalities, and Delirium in Medical ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Rhythm Disorders
Keywords: circadian misalignment
bright light
entrainment
zeitgeber
critical illness
delirium
actigraphy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 68
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with 2 cohorts
Primary purpose: TREATMENT

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

Eligibility criteria: 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).

Primary outcomes:
measure: Circadian Alignment
timeFrame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Days of Delirium
timeFrame: Study Day 1-30 (patients will be censored at hospital discharge)
Secondary outcomes:
measure: Circadian Alignment, Secondary Measures, Body surface temperature gradient
timeFrame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Circadian Alignment, Secondary Measures, Continous Heart Rate
timeFrame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.
timeFrame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Feasibility, Patient Acceptance
timeFrame: Study Day 1
measure: Feasibility, Patient Tolerance Time
timeFrame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Feasibility, Patient Tolerance Symptoms
timeFrame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Feasibility, Intervention Fidelity
timeFrame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Feasibility, Intervention Sustainability
timeFrame: Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Total Sleep
timeFrame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
measure: Sleep Efficiency
timeFrame: Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital, York Street Campus
state: Connecticut
Study officials:
affiliation: Yale University
name: Melissa Knauert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: