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Feasibility Pilot of Bright Light in the Intensive Care Unit

Sponsor
Yale University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT03568045
Collaborator
(none)
15
Enrollment
1
Location
3
Arms
63.9
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: standard light
  • Device: 10,000 lux bright light, 4 hours
  • Device: 10,000 lux bright light, 8 hours
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
a pilot randomized control trial of 3 cohort groups.a pilot randomized control trial of 3 cohort groups.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Device Feasibility
Official Title:
Feasibility Pilot of Bright Light in the Intensive Care Unit
Actual Study Start Date :
Dec 3, 2018
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Usual care, standard light

Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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.

Device: standard light
usual care
Experimental: 10,000 lux bright light, 4 hours

Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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 8am to noon starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred. Feasibility metrics will be collected.

Device: 10,000 lux bright light, 4 hours
Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon.
Other Names:
  • Bright light, 4 hours

    		•
    Experimental: 10,000 lux bright light, 8 hours

    Patients will be enrolled within 30 hours of noon on enrollment day (e.g. at or after 6am 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 8am to 4pm starting on study day 2 and continuing through study day 5. Bright light exposure will occur in the Intensive Care Unit (ICU) and on the floor if the patient is transferred. Feasibility metrics will be collected.

    Device: 10,000 lux bright light, 8 hours
    Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm.
    Other Names:
  • Bright light, 8 hours

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tolerance (time): Percent of intended treatment hours that patient continues with the delivery of bright light [Study Day 2-5]

      Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.

    Secondary Outcome Measures

    1. Acceptance: Percent of patients/surrogates who agree to bright light when initially described [Study Day 1 (enrollment)]

      Percent of patients/surrogates who agree to bright light when initially described to them.

    2. Tolerance (symptoms): Percent of patients who develop eye strain, headache or visual disturbance. [Study Day 2-5]

      Percent of patients who develop eye strain, headache or visual disturbance.

    3. Fidelity: Percent of time per day that device delivers the planned dose of light [Study Day 2-5]

      Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).

    4. Sustainability: Percent of intended intervention days that the device is used. [Study Day 2-5]

      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."

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. Home medications include: melatonin, melatonin agonist

    2. Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility

    3. History of bipolar disease (Bright light therapy possibly unsafe in this population).

    4. Paralyzed (due to injury, disease or medications)

    5. Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease

    6. Homeless

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale New Haven Hospital, York Street Campus New Haven Connecticut United States 06520

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Melissa Knauert, MD, PhD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03568045
    Other Study ID Numbers:
    • 2000022284
    First Posted:
    Jun 26, 2018
    Last Update Posted:
    May 31, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Yale University
    circadian misalignment
    entrainment
    zeitgeber
    bright light
    critical illness
    Additional relevant MeSH terms:
    Sleep Wake Disorders
    Parasomnias
    Sleep Disorders, Circadian Rhythm

    Study Results

    No Results Posted as of May 31, 2022