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

Primary Purpose

Circadian Rhythm Disorders

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Daytime Bright Light

Usual Light

About this trial

This is an interventional treatment trial for Circadian Rhythm Disorders focused on measuring circadian misalignment, bright light, entrainment, zeitgeber, critical illness, delirium, actigraphy

Eligibility Criteria

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

Inclusion Criteria:

Hospital admission ≤30 hours at noon on enrollment day
Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment
Age ≥50 years

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)
- 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).

Sites / Locations

Yale New Haven Hospital, York Street CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bright Light

Usual Light

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Circadian Alignment

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.

Days of Delirium

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.

Secondary Outcome Measures

Circadian Alignment, Secondary Measures, Body surface temperature gradient

The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.

Circadian Alignment, Secondary Measures, Continous Heart Rate

The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate.

Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.

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, Patient Acceptance

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

Feasibility, Patient Tolerance Time

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

Feasibility, Patient Tolerance Symptoms

Percent of patients who develop eyestrain, headache or visual disturbance (combined outcome).

Feasibility, Intervention Fidelity

Percent of time per day that device delivers the planned dose of light.

Feasibility, Intervention Sustainability

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

The investigators will measure (and control for) the total amount of sleep (sleep quantity) via actigraphy.

Sleep Efficiency

The investigators will measure (and control for) overnight sleep efficiency (sleep quality) via actigraphy.

Full Information

NCT ID

NCT03684460

First Posted

June 5, 2018

Last Updated

October 16, 2023

Sponsor

Yale University

1. Study Identification

Unique Protocol Identification Number

NCT03684460

Brief Title

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

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 8, 2019 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2023 (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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Circadian Rhythm Disorders

Keywords

circadian misalignment, bright light, entrainment, zeitgeber, critical illness, delirium, actigraphy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized controlled trial with 2 cohorts

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Bright Light

Arm Type

Experimental

Arm Description

Arm Title

Usual Light

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Daytime Bright Light

Intervention Description

Daytime Bright Light (DBL) will be delivered by a free-standing apparatus set to deliver 10,000 lux. The device will be placed at the bedside within 36 inches of the patient's head and is expected to provide at least 1,250 lux at the angle of gaze. To remain in the study, the patient must be in the Intensive Care Unit (ICU) through 13:00 on day 2 (e.g., the first day of potential intervention). After day 2, DBL and other study activities will continue if the patient is transferred out of the ICU to the general medical floor.

Intervention Type

Device

Intervention Name(s)

Usual Light

Intervention Description

Usual care lighting in ICU. To remain in the study usual care patients must also remain in the MICU through 13:00 on day 2.

Primary Outcome Measure Information:

Title

Circadian Alignment

Description

Time Frame

Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Days of Delirium

Description

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.

Time Frame

Study Day 1-30 (patients will be censored at hospital discharge)

Secondary Outcome Measure Information:

Title

Circadian Alignment, Secondary Measures, Body surface temperature gradient

Description

The investigators will include additional measures of circadian alignment in our analysis: continuous body surface temperature gradient.

Time Frame

Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Circadian Alignment, Secondary Measures, Continous Heart Rate

Description

The investigators will include additional measures of circadian alignment in our analysis: continuous heart rate.

Time Frame

Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Circadian Alignment, Secondary Measures, urinary 6-sulfatoxymelatonin.

Description

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).

Time Frame

Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Feasibility, Patient Acceptance

Description

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

Time Frame

Study Day 1

Title

Feasibility, Patient Tolerance Time

Description

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

Time Frame

Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Feasibility, Patient Tolerance Symptoms

Description

Percent of patients who develop eyestrain, headache or visual disturbance (combined outcome).

Time Frame

Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Feasibility, Intervention Fidelity

Description

Percent of time per day that device delivers the planned dose of light.

Time Frame

Study Day 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Feasibility, Intervention Sustainability

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 2-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Total Sleep

Description

The investigators will measure (and control for) the total amount of sleep (sleep quantity) via actigraphy.

Time Frame

Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

Title

Sleep Efficiency

Description

The investigators will measure (and control for) overnight sleep efficiency (sleep quality) via actigraphy.

Time Frame

Study Day 1-30 (to study day 5 or MICU discharge whichever is longer, patients will be censored at hospital discharge).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Hospital admission ≤30 hours at noon on enrollment day Expected to say in the Medical Intensive Care Unit (MICU) ≥24 hours after enrollment Age ≥50 years 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) 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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Melissa Knauert, MD, PhD

Phone

203-785-4163

melissa.knauert@yale.edu

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

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

MICU Director

First Name & Middle Initial & Last Name & Degree

Melissa P Knauert, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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