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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23HL138229-01A1 | U.S. NIH Grant/Contract | View source | |
| 1R03HL157009-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care, standard light | Active Comparator | 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. |
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| 10,000 lux bright light, 4 hours | Experimental | 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. |
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| 10,000 lux bright light, 8 hours | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standard light | Device | usual care |
| |
| 10,000 lux bright light, 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Study Day 2-5 |
| Measure | Description | Time Frame |
|---|---|---|
| Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described | Percent of patients/surrogates who agree to study enrollment including bright light when initially described to them. | Study Day 1 (enrollment) |
| Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance. |
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Inclusion Criteria:
Exclusion Criteria:
At significant risk for pre-existing circadian abnormalities:
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
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Knauert, MD, PhD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale New Haven Hospital, York Street Campus | New Haven | Connecticut | 06520 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. standard light: usual care |
| FG001 | 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. 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. |
| FG002 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All consented and enrolled patients included in baseline characteristics.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. standard light: usual care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Enrolled patients who were randomized to either bright light treatment arm. | Posted | Mean | Standard Error | percentage of intended treatment hours | Study Day 2-5 |
|
Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. standard light: usual care |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Systematic Assessment | Death during index hospitalization. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Visual strain | Eye disorders | Systematic Assessment | Visual strain. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Knauert | Yale School of Medicine | 203-785-4162 | melissa.knauert@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2022 | May 21, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 19, 2022 | May 21, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020178 | Sleep Disorders, Circadian Rhythm |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D021081 | Chronobiology Disorders |
| D009422 | Nervous System Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
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a pilot randomized control trial of 3 cohort groups.
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| Device |
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. |
|
|
| 10,000 lux bright light, 8 hours | Device | 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. |
|
|
Percent of patients who develop eye strain, headache or visual disturbance. |
| Study Day 2-5 |
| 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). | Study Day 2-5 |
| 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." | Study Day 2-5 |
| BG001 |
| 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. 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. |
| BG002 | 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. 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. 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. |
| OG002 | 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. 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. |
|
|
| Secondary | Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described | Percent of patients/surrogates who agree to study enrollment including bright light when initially described to them. | Eligible patients who were approached for consent. | Posted | Count of Participants | Participants | Study Day 1 (enrollment) |
|
|
|
| Secondary | Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance. | Percent of patients who develop eye strain, headache or visual disturbance. | All enrolled patients. | Posted | Count of Participants | Participants | Study Day 2-5 |
|
|
|
| Secondary | 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). | Enrolled patients randomized to either bright light treatment arm. | Posted | Mean | Standard Error | percentage of time per day | Study Day 2-5 |
|
|
|
| Secondary | 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." | Enrolled patients randomized to either bright light treatment arm. | Posted | Mean | Standard Error | percentage of intervention days used | Study Day 2-5 |
|
|
|
| 1 |
| 2 |
| 1 |
| 2 |
| 0 |
| 2 |
| EG001 | 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. 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. | 2 | 9 | 2 | 9 | 2 | 9 |
| EG002 | 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. 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. | 0 | 5 | 0 | 5 | 0 | 5 |
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| D009784 |
| Occupational Diseases |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |