Circadian Rhythm Disorders Clinical Trial
Official title:
Effects of Blocking Blue Light at Night on Patient Outcomes After Elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | March 2025 |
Est. primary completion date | March 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years to 75 Years |
Eligibility | Inclusion Criteria: - Both men and women that are undergoing elective (non-emergency) - on-pump CABG surgery, - AVR, - MVR, - CABG AVR, - CABG MVR or - SAH - 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 |
Country | Name | City | State |
---|---|---|---|
United States | West Virginia University Heart and Vascular Institute | Morgantown | West Virginia |
Lead Sponsor | Collaborator |
---|---|
West Virginia University |
United States,
Brainard GC, Sliney D, Hanifin JP, Glickman G, Byrne B, Greeson JM, Jasser S, Gerner E, Rollag MD. Sensitivity of the human circadian system to short-wavelength (420-nm) light. J Biol Rhythms. 2008 Oct;23(5):379-86. doi: 10.1177/0748730408323089. — View Citation
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Figueiro MG, Lesniak NZ, Rea MS. Implications of controlled short-wavelength light exposure for sleep in older adults. BMC Res Notes. 2011 Sep 8;4:334. doi: 10.1186/1756-0500-4-334. — View Citation
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in baseline serum cytokine profile | Assessed via an immuno multiplex panel for the following cytokines:TNF-a, IL-1ß, IL-6, IL-2, and IL-8. Units of measure for all cytokines are pg/mL. | 5 days post-surgery | |
Primary | Change in baseline serum cytokine profile | Assessed via an immuno multiplex panel for the following cytokines:TNF-a, IL-1ß, IL-6, IL-2, and IL-8. Units of measure for all cytokines are pg/mL. | 30 days post-surgery | |
Primary | Change in baseline serum cardiac ischemia profile | 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. | 5 days post-surgery | |
Primary | Change in baseline serum cardiac ischemia profile | 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. | 30 days post-surgery | |
Primary | Change in baseline mood (Hamilton Depression Scale) | Hamilton Depression Scale questionnaire. Scores between 0 - 54, with increasing scores indicating severity of depression. | 5 days post-surgery | |
Primary | Change in baseline mood (Hamilton Depression Scale) | Hamilton Depression Scale questionnaire. Scores between 0 - 54, with increasing scores indicating severity of depression. | 30 days post-surgery | |
Primary | Change in baseline sleep (PSQI) | Pittsburgh Sleep Quality Index survey. Scores between 0 - 21, a greater score is worse sleep/more impairment. | 5 days post-surgery | |
Primary | Change in baseline sleep (PSQI) | Pittsburgh Sleep Quality Index (PSQI) survey. Scores between 0 - 21, a greater score is worse sleep/more impairment. | 30 days post-surgery | |
Primary | Change in baseline central executive cognitive function (Trail Making Test (part B)) | 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. | 5 days post-surgery | |
Primary | Change in baseline central executive cognitive function (Trail Making Test (part B)) | 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. | 30 days post-surgery | |
Primary | Change in baseline cognitive function (WAIS-R) | 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. | 5 days post-surgery | |
Primary | Change in baseline cognitive function (WAIS-R) | 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. | 30 days post-surgery |
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