Trial Outcomes & Findings for Feasibility Pilot of Bright Light in the Intensive Care Unit (NCT NCT03568045)

NCT ID: NCT03568045

Last Updated: 2024-06-17

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

Study Day 2-5

Results posted on

2024-06-17

Participant Flow

Participant milestones

Participant milestones
Measure
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
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.
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.
Overall Study
STARTED
2
9
5
Overall Study
COMPLETED
2
9
5
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Pilot of Bright Light in the Intensive Care Unit

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Usual Care, Standard Light
n=2 Participants
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
10,000 Lux Bright Light, 4 Hours
n=9 Participants
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.
10,000 Lux Bright Light, 8 Hours
n=5 Participants
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.
Total
n=16 Participants
Total of all reporting groups
Age, Continuous
67.0 years
STANDARD_DEVIATION 5.7 • n=93 Participants
73.6 years
STANDARD_DEVIATION 10.6 • n=4 Participants
73.6 years
STANDARD_DEVIATION 11.9 • n=27 Participants
72.8 years
STANDARD_DEVIATION 10.3 • n=483 Participants
Sex: Female, Male
Female
1 Participants
n=93 Participants
3 Participants
n=4 Participants
4 Participants
n=27 Participants
8 Participants
n=483 Participants
Sex: Female, Male
Male
1 Participants
n=93 Participants
6 Participants
n=4 Participants
1 Participants
n=27 Participants
8 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=93 Participants
8 Participants
n=4 Participants
5 Participants
n=27 Participants
15 Participants
n=483 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Race (NIH/OMB)
Asian
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
Race (NIH/OMB)
White
2 Participants
n=93 Participants
7 Participants
n=4 Participants
5 Participants
n=27 Participants
14 Participants
n=483 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=93 Participants
1 Participants
n=4 Participants
0 Participants
n=27 Participants
1 Participants
n=483 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
0 Participants
n=483 Participants

PRIMARY outcome

Timeframe: Study Day 2-5

Population: Enrolled patients who were randomized to either bright light treatment arm.

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

Outcome measures

Outcome measures
Measure
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
10,000 Lux Bright Light, 4 Hours
n=9 Participants
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.
10,000 Lux Bright Light, 8 Hours
n=5 Participants
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.
Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light
59 percentage of intended treatment hours
Standard Error 11
61 percentage of intended treatment hours
Standard Error 13

SECONDARY outcome

Timeframe: Study Day 1 (enrollment)

Population: Eligible patients who were approached for consent.

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

Outcome measures

Outcome measures
Measure
Usual Care, Standard Light
n=67 Participants
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
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.
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.
Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described
59 Participants

SECONDARY outcome

Timeframe: Study Day 2-5

Population: All enrolled patients.

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

Outcome measures

Outcome measures
Measure
Usual Care, Standard Light
n=2 Participants
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
10,000 Lux Bright Light, 4 Hours
n=9 Participants
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.
10,000 Lux Bright Light, 8 Hours
n=5 Participants
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.
Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance.
0 Participants
2 Participants
1 Participants

SECONDARY outcome

Timeframe: Study Day 2-5

Population: Enrolled patients randomized to either bright light treatment arm.

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

Outcome measures

Outcome measures
Measure
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
10,000 Lux Bright Light, 4 Hours
n=9 Participants
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.
10,000 Lux Bright Light, 8 Hours
n=5 Participants
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.
Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light
55 percentage of time per day
Standard Error 8
55 percentage of time per day
Standard Error 11

SECONDARY outcome

Timeframe: Study Day 2-5

Population: Enrolled patients randomized to either bright light treatment arm.

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."

Outcome measures

Outcome measures
Measure
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
10,000 Lux Bright Light, 4 Hours
n=9 Participants
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.
10,000 Lux Bright Light, 8 Hours
n=5 Participants
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.
Sustainability: Percent of Intended Intervention Days That the Device is Used.
94 percentage of intervention days used
Standard Error 6
88 percentage of intervention days used
Standard Error 7

Adverse Events

Usual Care, Standard Light

Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths

10,000 Lux Bright Light, 4 Hours

Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths

10,000 Lux Bright Light, 8 Hours

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Usual Care, Standard Light
n=2 participants at risk
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
10,000 Lux Bright Light, 4 Hours
n=9 participants at risk
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.
10,000 Lux Bright Light, 8 Hours
n=5 participants at risk
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.
Cardiac disorders
Death
50.0%
1/2 • Number of events 1 • Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.
22.2%
2/9 • Number of events 2 • Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.
0.00%
0/5 • Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.

Other adverse events

Other adverse events
Measure
Usual Care, Standard Light
n=2 participants at risk
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
10,000 Lux Bright Light, 4 Hours
n=9 participants at risk
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.
10,000 Lux Bright Light, 8 Hours
n=5 participants at risk
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.
Eye disorders
Visual strain
0.00%
0/2 • Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.
22.2%
2/9 • Number of events 2 • Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.
0.00%
0/5 • Patients were followed for outcomes until discharge from the index MICU/hospital admission, up to study day 5.

Additional Information

Dr. Melissa Knauert

Yale School of Medicine

Phone: 203-785-4162

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place