What this study is
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.
What's being tested
- Blue light-blocking goggles
Intervention · OTHER
- Clear goggles
Intervention · OTHER
Both interventions
Participants will be randomly assigned to one of the two intervention groups.
Study details
- Official title
- Effects of Blocking Blue Light at Night on Patient Outcomes After Elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
- Sponsor
- West Virginia University
- Conditions
- Circadian Rhythm Disorders
- Enrolling
- 80 people
- Starts
- 2021-09-20
- Est. completion
- 2027-05
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openWest Virginia University Heart and Vascular Institute
Morgantown, West Virginia, United States
- James C. Walton, PhD · Contact304.293.3490james.walton@hsc.wvu.edu
- Pallavi Sharma, PhD · Contactpallavi.sharma@hsc.wvu.edu
Recruiting
Study team
Sponsor
West Virginia University
Study ID 2002905562
Principal investigator
Randy J Nelson, PhD
West Virginia University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.