NCT04578249 Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
| NCT ID | NCT04578249 |
| Status | Recruiting |
| Phase | — |
| Sponsor | West Virginia University |
| Condition | Circadian Rhythm Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-09-20 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2021-09-20 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Randy J Nelson, PhD
PRINCIPAL INVESTIGATOR
West Virginia University
Frequently Asked Questions
Who can join the NCT04578249 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 75 Years, studying Circadian Rhythm Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04578249 currently recruiting?
Yes, NCT04578249 is actively recruiting participants. Contact the research team at james.walton@hsc.wvu.edu for enrollment information.
Where is the NCT04578249 trial being conducted?
This trial is being conducted at Morgantown, United States.
Who is sponsoring the NCT04578249 clinical trial?
NCT04578249 is sponsored by West Virginia University. The principal investigator is Randy J Nelson, PhD at West Virginia University. The trial plans to enroll 80 participants.