RecruitingNot Applicable

Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH

United States80 participantsStarted 2021-09-20

Plain-language 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.

Who can participate

Age range

45 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in baseline serum cytokine profile

Timeframe: 5 days post-surgery

Change in baseline serum cytokine profile

Timeframe: 30 days post-surgery

Change in baseline serum cardiac ischemia profile

Timeframe: 5 days post-surgery

Change in baseline serum cardiac ischemia profile

Timeframe: 30 days post-surgery

Change in baseline mood (Hamilton Depression Scale)

Timeframe: 5 days post-surgery

Change in baseline mood (Hamilton Depression Scale)

Timeframe: 30 days post-surgery

Change in baseline sleep (PSQI)

Timeframe: 5 days post-surgery

Trial details

NCT IDNCT04578249

SponsorWest Virginia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

James C Walton, PhD

3042933490 james.walton@hsc.wvu.edu

View on ClinicalTrials.gov More Circadian Rhythm Disorders trials

Plain-language summary

Who can participate

Age range

45 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in baseline serum cytokine profile

Timeframe: 5 days post-surgery

Change in baseline serum cytokine profile

Timeframe: 30 days post-surgery

Change in baseline serum cardiac ischemia profile

Timeframe: 5 days post-surgery

Change in baseline serum cardiac ischemia profile

Timeframe: 30 days post-surgery

Change in baseline mood (Hamilton Depression Scale)

Timeframe: 5 days post-surgery

Change in baseline mood (Hamilton Depression Scale)

Timeframe: 30 days post-surgery

Change in baseline sleep (PSQI)

Timeframe: 5 days post-surgery