Recruiting

Blue Light Blocking

Sponsor:

West Virginia University

Code:

NCT04578249

Conditions

Circadian Rhythm Disorders

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Interventions

Blue light-blocking goggles

Clear goggles

Study Details

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.

Conditions

Circadian Rhythm Disorders

Study ID

NCT04578249

Start date

Sep 20, 2021

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Blue light-blocking goggles

Participants will be randomly assigned to one of the two intervention groups.

Clear goggles

Participants will be randomly assigned to one of the two intervention groups.

Primary outcome measure

  • Change in baseline serum cytokine profile [ Time Frame: 5 days post-surgery ]
  • Change in baseline serum cytokine profile [ Time Frame: 30 days post-surgery ]
  • Change in baseline serum cardiac ischemia profile [ Time Frame: 5 days post-surgery ]
  • Change in baseline serum cardiac ischemia profile [ Time Frame: 30 days post-surgery ]
  • Change in baseline mood (Hamilton Depression Scale) [ Time Frame: 5 days post-surgery ]
  • Change in baseline mood (Hamilton Depression Scale) [ Time Frame: 30 days post-surgery ]
  • Change in baseline sleep (PSQI) [ Time Frame: 5 days post-surgery ]
  • Change in baseline sleep (PSQI) [ Time Frame: 30 days post-surgery ]
  • Change in baseline central executive cognitive function (Trail Making Test (part B)) [ Time Frame: 5 days post-surgery ]
  • Change in baseline central executive cognitive function (Trail Making Test (part B)) [ Time Frame: 30 days post-surgery ]
  • Change in baseline cognitive function (WAIS-R) [ Time Frame: 5 days post-surgery ]
  • Change in baseline cognitive function (WAIS-R) [ Time Frame: 30 days post-surgery ]

Central Contacts and Locations

Central contacts

James C Walton, PhD

3042933490james.walton@hsc.wvu.edu

Pallavi Sharma, PhD

pallavi.sharma@hsc.wvu.edu

Locations

West Virginia University Heart and Vascular Institute

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

James C. Walton, PhD

304.293.3490james.walton@hsc.wvu.edu

Pallavi Sharma, PhD

pallavi.sharma@hsc.wvu.edu

More Information

Sponsor

West Virginia University

Last update posted

Apr 20, 2026

Last verified

Apr, 2026

Keywords

  • CABG
  • coronary artery bypass graft
  • light at night
  • dim light at night
  • inflammation
  • cognition
  • blue light

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by West Virginia University on 2026-04-20.