Circadian Rhythm Sleep Disorder, Unspecified
Conditions
Keywords
circadian misalignment, entrainment, zeitgeber, bright light, critical illness
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.
Interventions
DEVICEstandard light
usual care
DEVICE10,000 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.
DEVICE10,000 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)
Intervention model description
a pilot randomized control trial of 3 cohort groups.
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described | Study Day 1 (enrollment) | Percent of patients/surrogates who agree to study enrollment including bright light when initially described to them. |
| 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. |
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 2 |
| 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. | 9 |
| 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. | 5 |
| Total | 16 |
Baseline characteristics
| Characteristic | Usual Care, Standard Light | 10,000 Lux Bright Light, 4 Hours | 10,000 Lux Bright Light, 8 Hours | Total |
|---|---|---|---|---|
| Age, Continuous | 67.0 years STANDARD_DEVIATION 5.7 | 73.6 years STANDARD_DEVIATION 10.6 | 73.6 years STANDARD_DEVIATION 11.9 | 72.8 years STANDARD_DEVIATION 10.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 8 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2 Participants | 7 Participants | 5 Participants | 14 Participants |
| Sex: Female, Male Female | 1 Participants | 3 Participants | 4 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 6 Participants | 1 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 2 | 2 / 9 | 0 / 5 |
| other Total, other adverse events | 0 / 2 | 2 / 9 | 0 / 5 |
| serious Total, serious adverse events | 1 / 2 | 2 / 9 | 0 / 5 |
Outcome results
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.
Time frame: Study Day 2-5
Population: Enrolled patients who were randomized to either bright light treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10,000 Lux Bright Light, 4 Hours | 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 |
| 10,000 Lux Bright Light, 8 Hours | Tolerance (Time): Percent of Intended Treatment Hours That Patient Continues With the Delivery of Bright Light | 61 percentage of intended treatment hours | Standard Error 13 |
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.
Time frame: Study Day 1 (enrollment)
Population: Eligible patients who were approached for consent.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care, Standard Light | Acceptance: Percent of Patients/Surrogates Who Agree to Bright Light When Initially Described | 59 Participants |
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).
Time frame: Study Day 2-5
Population: Enrolled patients randomized to either bright light treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10,000 Lux Bright Light, 4 Hours | Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light | 55 percentage of time per day | Standard Error 8 |
| 10,000 Lux Bright Light, 8 Hours | Fidelity: Percent of Time Per Day That Device Delivers the Planned Dose of Light | 55 percentage of time per day | Standard Error 11 |
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.
Time frame: Study Day 2-5
Population: Enrolled patients randomized to either bright light treatment arm.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 10,000 Lux Bright Light, 4 Hours | Sustainability: Percent of Intended Intervention Days That the Device is Used. | 94 percentage of intervention days used | Standard Error 6 |
| 10,000 Lux Bright Light, 8 Hours | Sustainability: Percent of Intended Intervention Days That the Device is Used. | 88 percentage of intervention days used | Standard Error 7 |
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.
Time frame: Study Day 2-5
Population: All enrolled patients.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care, Standard Light | Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance. | 0 Participants |
| 10,000 Lux Bright Light, 4 Hours | Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance. | 2 Participants |
| 10,000 Lux Bright Light, 8 Hours | Tolerance (Symptoms): Percent of Patients Who Develop Eye Strain, Headache or Visual Disturbance. | 1 Participants |