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Feasibility Pilot of Bright Light in the Intensive Care Unit

Primary Purpose

Circadian Rhythm Sleep Disorder, Unspecified

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
standard light
10,000 lux bright light, 4 hours
10,000 lux bright light, 8 hours
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Circadian Rhythm Sleep Disorder, Unspecified focused on measuring circadian misalignment, entrainment, zeitgeber, bright light, critical illness

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Yale New Haven Hospital, York Street Campus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual care, standard light

10,000 lux bright light, 4 hours

10,000 lux bright light, 8 hours

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Tolerance (time): Percent of intended treatment hours that patient continues with the delivery of bright light
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.

Secondary Outcome Measures

Acceptance: Percent of patients/surrogates who agree to bright light when initially described
Percent of patients/surrogates who agree to bright light when initially described to them.
Tolerance (symptoms): Percent of patients who develop eye strain, headache or visual disturbance.
Percent of patients who develop eye strain, headache or visual disturbance.
Fidelity: Percent of time per day that device delivers the planned dose of light
Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).
Sustainability: Percent of intended intervention days that the device is used.
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."

Full Information

First Posted
June 5, 2018
Last Updated
April 5, 2023
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT03568045
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 3, 2018 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Rhythm Sleep Disorder, Unspecified
Keywords
circadian misalignment, entrainment, zeitgeber, bright light, critical illness

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
a pilot randomized control trial of 3 cohort groups.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care, standard light
Arm Type
Active Comparator
Arm Description
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.
Arm Title
10,000 lux bright light, 4 hours
Arm Type
Experimental
Arm Description
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.
Arm Title
10,000 lux bright light, 8 hours
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
standard light
Intervention Description
usual care
Intervention Type
Device
Intervention Name(s)
10,000 lux bright light, 4 hours
Other Intervention Name(s)
Bright light, 4 hours
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
10,000 lux bright light, 8 hours
Other Intervention Name(s)
Bright light, 8 hours
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerance (time): Percent of intended treatment hours that patient continues with the delivery of bright light
Description
Percent of intended treatment hours that patient continues with the delivery of bright light once exposed to bright light.
Time Frame
Study Day 2-5
Secondary Outcome Measure Information:
Title
Acceptance: Percent of patients/surrogates who agree to bright light when initially described
Description
Percent of patients/surrogates who agree to bright light when initially described to them.
Time Frame
Study Day 1 (enrollment)
Title
Tolerance (symptoms): Percent of patients who develop eye strain, headache or visual disturbance.
Description
Percent of patients who develop eye strain, headache or visual disturbance.
Time Frame
Study Day 2-5
Title
Fidelity: Percent of time per day that device delivers the planned dose of light
Description
Percent of time per day that device delivers the planned dose of light (out of 4 or 8 hours depending on intervention arm).
Time Frame
Study Day 2-5
Title
Sustainability: Percent of intended intervention days that the device is used.
Description
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."
Time Frame
Study Day 2-5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital admission ≤30 hours at noon on enrollment day Expected to say in the Medical Intensive Care Unit ≥24 hours after enrollment Age ≥50 years History of hypertension based on chart review and presence of 1 or more home blood pressure medications Able to understand English Exclusion Criteria: 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 Home medications include: melatonin, melatonin agonist Transferred from an outside hospital, long-term care, rehabilitation, or acute care facility History of bipolar disease (Bright light therapy possibly unsafe in this population). Paralyzed (due to injury, disease or medications) Diagnosed with hepatic encephalopathy in the setting of end-stage liver disease Homeless
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Knauert, MD, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale New Haven Hospital, York Street Campus
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Feasibility Pilot of Bright Light in the Intensive Care Unit

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