Feasibility Pilot of Bright Light in the Intensive Care Unit

Not Applicable

Completed

• Conditions: Circadian Rhythm Sleep Disorder, Unspecified
• Interventions: Device: standard light; Device: 10,000 lux bright light, 4 hours; Device: 10,000 lux bright light, 8 hours

• Registration Number: NCT03568045
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-21
• Study First Posted: 2018-06-26
• Study Start: 2018-12-03
• Primary Completion: 2023-03-31
• Study Completion: 2024-03-31
• Results First Submitted: 2024-05-21
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-14
• Last Update Submitted: 2024-06-14
• Results First Posted: 2024-06-17
• Last Update Posted: 2024-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care, standard light	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.
10,000 lux bright light, 4 hours	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, 8 hours	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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.
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.
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."

Trial Locations

Locations (1)

Yale New Haven Hospital, York Street Campus; 🇺🇸 New Haven, Connecticut, United States