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Blue Light Blocking for Heart Surgery Recovery
N/A
Recruiting
Led By Randy J Nelson, PhD
Research Sponsored by West Virginia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
No history of diagnosed psychiatric disorders or organ failure
Both men and women undergoing elective (non-emergency) on-pump CABG surgery, AVR, MVR, CABG AVR, CABG MVR, or SAH
Must not have
Combined cardiac operations
Any immune disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days post-surgery
Summary
This trial is testing whether filtering out blue light at nighttime reduces post-surgical inflammation and moderates cognitive decline, mood, and sleep alterations in patients undergoing heart surgery.
Who is the study for?
This trial is for men and women without psychiatric disorders or organ failure, who are scheduled for elective heart surgeries like CABG, AVR, MVR, or SAH. Participants should not have a history of cardiac surgery, clotting disorders, severe lung disease (COPD), acute infections, cognitive deficits like dementia, immune disorders or conditions that may require blood transfusion during/after surgery.
What is being tested?
The study tests if wearing blue light-blocking goggles at night after certain heart surgeries can reduce inflammation and improve mood, sleep quality and prevent cognitive decline. It compares the effects with clear goggles to see if blocking blue light leads to better recovery outcomes.
What are the potential side effects?
Since this intervention involves non-invasive blue light-blocking goggles there might be minimal side effects such as discomfort from wearing the goggles. However specific side effects are not detailed in the provided information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have no diagnosed psychiatric disorders or organ failure.
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I am scheduled for a non-emergency heart surgery that involves a heart-lung machine.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am undergoing or have undergone multiple heart surgeries at once.
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I have an immune system disorder.
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My kidney and liver functions are normal.
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I currently have an infection.
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I am scheduled for elective aneurysm surgery.
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I have had heart surgery before.
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I have a condition that might require a blood transfusion during or after surgery.
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I have a blood clotting disorder.
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I have chronic obstructive pulmonary disease.
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I have been diagnosed with a psychiatric disorder such as depression or anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days post-surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in baseline central executive cognitive function (Trail Making Test (part B))
Change in baseline cognitive function (WAIS-R)
Change in baseline mood (Hamilton Depression Scale)
+3 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Blue-light blocking gogglesExperimental Treatment1 Intervention
Patients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given blue-light blocking goggles to wear at nighttime.
Group II: Clear gogglesPlacebo Group1 Intervention
Patients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given clear goggles to wear at nighttime.
Find a Location
Who is running the clinical trial?
West Virginia UniversityLead Sponsor
186 Previous Clinical Trials
64,843 Total Patients Enrolled
Randy J Nelson, PhDPrincipal InvestigatorWest Virginia University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with dementia or other memory problems.I am undergoing or have undergone multiple heart surgeries at once.I have an immune system disorder.My kidney and liver functions are normal.I currently have an infection.I am scheduled for elective aneurysm surgery.I have had heart surgery before.You have a severe blockage in the main artery on the left side of your heart.Your heart's pumping function is not strong enough (LVEF lower than 0.5).I have a condition that might require a blood transfusion during or after surgery.I have a blood clotting disorder.I have chronic obstructive pulmonary disease.I have no diagnosed psychiatric disorders or organ failure.I have been diagnosed with a psychiatric disorder such as depression or anxiety.I am scheduled for a non-emergency heart surgery that involves a heart-lung machine.
Research Study Groups:
This trial has the following groups:- Group 1: Clear goggles
- Group 2: Blue-light blocking goggles
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.