NCT04578249 · West Virginia University
Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
What this study is about
Purpose The purpose of this study is to determine whether filtering out blue light at nighttime reduces post-surgical inflammation and/or moderates cognitive decline and mood and sleep alterations in patients undergoing elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery.
View original scientific description
Purpose The purpose of this study is to determine whether filtering out blue light at nighttime reduces post-surgical inflammation and/or moderates cognitive decline and mood and sleep alterations in patients undergoing elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery. If manipulating nighttime light in hospital rooms improves patient outcomes, then it would be a relatively easy and inexpensive innovation that could reduce post-surgical complications and save millions of dollars per year in health care costs by shortening the length of hospital stays and reducing morbidity. The investigators aim to determine the relationship between inflammation and cognitive dysfunction after cardiac surgery.
Interventions
OTHER
Blue light-blocking goggles
Participants will be randomly assigned to one of the two intervention groups.
OTHER
Clear goggles
Participants will be randomly assigned to one of the two intervention groups.
Primary outcome measures
Change in baseline serum cytokine profile
Time frame: 5 days post-surgery
Assessed via an immuno multiplex panel for the following cytokines:TNF-α, IL-1β, IL-6, IL-2, and IL-8. Units of measure for all cytokines are pg/mL.
Change in baseline serum cytokine profile
Time frame: 30 days post-surgery
Assessed via an immuno multiplex panel for the following cytokines:TNF-α, IL-1β, IL-6, IL-2, and IL-8. Units of measure for all cytokines are pg/mL.
Change in baseline serum cardiac ischemia profile
Time frame: 5 days post-surgery
Assessed via an immuno multiplex panel for the following indicators of ischemia: CRP, BNP, NT-proBNP, cardiac troponin T, and CK-MB. Units of measure for all indicators of ischemia are pg/mL.
Change in baseline serum cardiac ischemia profile
Time frame: 30 days post-surgery
Assessed via an immuno multiplex panel for the following indicators of ischemia: CRP, BNP, NT-proBNP, cardiac troponin T, and CK-MB. Units of measure for all indicators of ischemia are pg/mL.
Change in baseline mood (Hamilton Depression Scale)
Time frame: 5 days post-surgery
Hamilton Depression Scale questionnaire. Scores between 0 - 54, with increasing scores indicating severity of depression.
Change in baseline mood (Hamilton Depression Scale)
Time frame: 30 days post-surgery
Hamilton Depression Scale questionnaire. Scores between 0 - 54, with increasing scores indicating severity of depression.
Change in baseline sleep (PSQI)
Time frame: 5 days post-surgery
Pittsburgh Sleep Quality Index survey. Scores between 0 - 21, a greater score is worse sleep/more impairment.
Change in baseline sleep (PSQI)
Time frame: 30 days post-surgery
Pittsburgh Sleep Quality Index (PSQI) survey. Scores between 0 - 21, a greater score is worse sleep/more impairment.
Change in baseline central executive cognitive function (Trail Making Test (part B))
Time frame: 5 days post-surgery
Trail Making Test (part B) TMT B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Change in baseline central executive cognitive function (Trail Making Test (part B))
Time frame: 30 days post-surgery
Trail Making Test (part B) TMT B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment.
Change in baseline cognitive function (WAIS-R)
Time frame: 5 days post-surgery
Wechsler Adult Intelligence Scale-Revised (WAIS-R). Scores vary between subtests, but are on a scale between 0 - 135; a higher score indicates better performance.
Change in baseline cognitive function (WAIS-R)
Time frame: 30 days post-surgery
Wechsler Adult Intelligence Scale-Revised (WAIS-R). Scores vary between subtests, but are on a scale between 0 - 135; a higher score indicates better performance.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Both men and women that are undergoing elective (non-emergency)
- on-pump CABG surgery,
- CABG MVR or
- No history of diagnosed psychiatric disorders or organ failure
Exclusion criteria
- Evidence or diagnosis of dementia or other cognitive deficit
- Diagnosed psychiatric disorder (including depression and anxiety)
- Organ failure \[kidney (creatine \> 1.5 mg/dL), liver, etc.\]
- Chronic obstructive pulmonary disease,
- Any immune disorder
- Acute infection
- Prior cardiac surgery
- Elective aneurysms
- Combined cardiac operations
- Left main stenosis greater than 70%
- Left ventricular ejection fraction (LVEF) lower than 0.5
- Any condition that increases likelihood of the need for a blood transfusion during or after the surgery
- Clotting disorder
- Suspected less than 8th grade English reading comprehension level
Where
- Morgantown, West Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 20, 2026 · Source of record for eligibility and locations