Feasibility Pilot of Bright Light in the Intensive Care Unit

Circadian Rhythm Sleep Disorder, Unspecified Clinical Trial

Official title:

Feasibility Pilot of Bright Light in the Intensive Care Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03568045
• Other study ID #: 2000022284
• Secondary ID: 1K23HL138229-01A
• Status: Completed
• Phase: N/A
• Start date: December 3, 2018
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the feasibility of providing daytime bright light in the ICU in a pilot randomized controlled trial.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Circadian Rhythm Sleep Disorder, Unspecified
• Parasomnias
• Sleep Disorders, Circadian Rhythm
• Sleep Wake Disorders

Intervention

Device:
• standard light
usual care
• 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
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.

Locations

Country	Name	City	State
United States	Yale New Haven Hospital, York Street Campus	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Study Day 2-5
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.	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.	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).	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."	Study Day 2-5