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

April 16, 2026 updated by: Randy Nelson, West Virginia University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease is the leading cause of death in the US. Each year, more than 500,000 coronary revascularization surgeries are performed. The in-hospital mortality rate among patients undergoing coronary artery bypass graft (CABG) surgery has declined to less than 6% in recent years, but potentially serious complications still occur and can prolong hospitalization, impair quality of life, and substantially increase medical costs. Excessive postsurgical inflammation can contribute to adverse outcomes, and the investigators hypothesize that exposure of patients to extraneous light at night during in-hospital recovery potentiates the inflammatory response to Coronary artery bypass graft (CABG), aortic valve replacement (aAVR), mitral valve replacement (MVR), CABG with aortic valve replacement (CABG AVR), or CABG with mitral valve replacement (CABG MVR), in turn, compromising several aspects of recovery. This hypothesis is based on our mouse models of brief global and focal cerebral ischemia; mice exposed to dim light at night (dLAN) during ischemic recovery have substantially more inflammation, neurological damage, and functional deficits than mice exposed to dark nights during ischemic recovery. The circadian system of mammals, including mice and humans, is most sensitive to light within the blue range of the spectrum (450- 485 nm); substituting longer wavelength light for nighttime exposures of mice recovering from ischemia eliminates the detrimental effects of the exposure to light at night (LAN). Based on these data, the hypothesis is that filtering the light CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery patients are exposed to at night during in-hospital recovery will reduce inflammation, and in turn improve functional outcome.

Specific Goals To determine if exposure of patients to extraneous LAN during recovery in the hospital potentiates the post- surgical inflammatory response. In the proposed study, consenting patients undergoing elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be randomly assigned to (1) the control group which will wear goggles for 10h at night that allow the full spectrum of light to pass through or to (2) the experimental group which will wear goggles for 10h at night that filter out wavelengths of light between 450-485 nm (i.e. the part of the spectrum that activates photosensitive ganglion cells and alters entrainment of the circadian clock). Baseline and postsurgical measures of inflammation and cognitive function will be obtained prior to surgery and during recovery in the hospital. If exposure to short wavelength (blue) LAN increases post-cardiac surgery inflammation, then the experimental group with filtered goggles will have lower blood markers of inflammation than the control group. Furthermore, we predict that reduced inflammation among the experimental group will be associated with less severe cognitive deficits on post-surgical day 5 (typically the day before discharge). In summary, this project will determine whether night-time exposure to blue light while recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery in the hospital affects the post-surgical inflammatory response and outcome. This study is innovative in two regards: 1) it will the first study to determine how a factor of a hospital's physical environment influences recovery from a major surgery and 2) it will be the first CABG study to determine whether reduction of early post-operative inflammation improves heart function and cognitive function after surgery. Elevated post- surgical inflammation is associated with a wide range of negative outcomes. If LAN exposure in the hospital does increase post-surgical inflammation, then adjusting patient exposure to environmental lighting could prove to be an inexpensive and effective way to improve patient outcome for CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery and a wide range of medical conditions that have an inflammatory component.

In summary, the proposed study will determine whether exposure to extraneous LAN exacerbates inflammation and compromises recovery from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery. Our preliminary data indicated that cardiovascular patients are exposed to extraneous light several times per night while staying in the hospital and that LAN is associated with increased inflammation in both diurnal and nocturnal rodents [15]. The proposed project represents a "first step" aimed at determining whether hospital lighting affects inflammation. However, the payoff could be enormous; if manipulating nighttime light in hospital rooms improves patient outcomes, then it would be a relatively easy, 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Clear goggles
Patients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given clear goggles to wear at nighttime.
Other: Clear goggles
Participants will be randomly assigned to one of the two intervention groups.
Other Names:
  • Uvex (Honeywell, USA)
Experimental: Blue-light blocking goggles
Patients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given blue-light blocking goggles to wear at nighttime.
Other: Blue light-blocking goggles
Participants will be randomly assigned to one of the two intervention groups.
Other Names:
  • Uvex (Honeywell, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 days post-surgery
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.
30 days post-surgery
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.
5 days post-surgery
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.
30 days post-surgery
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.
5 days post-surgery
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.
30 days post-surgery
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.
5 days post-surgery
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.
30 days post-surgery
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.
5 days post-surgery
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.
30 days post-surgery
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.
5 days post-surgery
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.
30 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West Virginia University

Investigators

  • Principal Investigator: Randy J Nelson, PhD, West Virginia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2021

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

July 21, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002905562

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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