Clinical trial NCT03568045: Feasibility Pilot of Bright Light in the Intensive Care Unit
Official title: Feasibility Pilot of Bright Light in the Intensive Care Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Circadian Rhythm Sleep Disorder, Unspecified
Keywords: circadian misalignment
entrainment
zeitgeber
bright light
critical illness
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-06-26
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: a pilot randomized control trial of 3 cohort groups.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.

Detailed description: To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial. Feasibility will be assessed via the following metrics: daytime bright light is acceptable and tolerable to patients and has high fidelity and sustainability as an intervention.

Eligibility criteria: Inclusion Criteria:

1. Hospital admission ≤30 hours at noon on enrollment day
2. Expected to say in the Medical Intensive Care Unit ≥24 hours after enrollment
3. Age ≥50 years
4. History of hypertension based on chart review and presence of 1 or more home blood pressure medications
5. Able to understand English

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) OR 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 (\<1% population) or blind/disease of the optic nerve
   * Current history of substance abuse including alcohol (use in last 30 days)
   * Current or recent (last 1 year) shiftwork
2. Home medications include: melatonin, melatonin agonist
3. Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility
4. History of bipolar disease (Bright light therapy possibly unsafe in this population).
5. Paralyzed (due to injury, disease or medications)
6. Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease
7. Homeless

Primary outcomes:
measure: Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light
timeFrame: Study Day 2-5
Secondary outcomes:
measure: Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described
timeFrame: Study Day 1 (enrollment)
measure: Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.
timeFrame: Study Day 2-5
measure: Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light
timeFrame: Study Day 2-5
measure: Sustainability: Percent of Intended Intervention Days That the Device is Used.
timeFrame: Study Day 2-5
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: