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

NCT04578249 | Recruiting DMC

• 1 other identifier: 2002905562
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (12)

• Change in baseline serum cytokine profile

  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

  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

  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

  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)

  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)

  Hamilton Depression Scale questionnaire. Scores between 0 - 54, with increasing scores indicating severity of depression.

  30 days post-surgery

• Change in baseline sleep (PSQI)

  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)

  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))

  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))

  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)

  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)

  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

Study Arms (2)

Clear goggles

PLACEBO COMPARATOR

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

Blue-light blocking goggles

EXPERIMENTAL

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

Interventions

Blue light-blocking goggles OTHER

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

Also known as: Uvex (Honeywell, USA)

Blue-light blocking goggles

Clear goggles OTHER

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

Also known as: Uvex (Honeywell, USA)

Clear goggles

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• West Virginia University: lead

Study Sites (1)

West Virginia University Heart and Vascular Institute

Morgantown, West Virginia, 26506, United States

RECRUITING

Related Publications (15)

• Murkin JM, Newman SP, Stump DA, Blumenthal JA. Statement of consensus on assessment of neurobehavioral outcomes after cardiac surgery. Ann Thorac Surg. 1995 May;59(5):1289-95. doi: 10.1016/0003-4975(95)00106-u. No abstract available.

  PMID: 7733754 BACKGROUND

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 BACKGROUND

• Joyeux-Faure M, Durand M, Bedague D, Protar D, Incagnoli P, Paris A, Ribuot C, Levy P, Chavanon O. Evaluation of the effect of one large dose of erythropoietin against cardiac and cerebral ischemic injury occurring during cardiac surgery with cardiopulmonary bypass: a randomized double-blind placebo-controlled pilot study. Fundam Clin Pharmacol. 2012 Dec;26(6):761-70. doi: 10.1111/j.1472-8206.2011.00992.x. Epub 2011 Sep 20.

  PMID: 21929528 BACKGROUND

• Brainard GC, Sliney D, Hanifin JP, Glickman G, Byrne B, Greeson JM, Jasser S, Gerner E, Rollag MD. Sensitivity of the human circadian system to short-wavelength (420-nm) light. J Biol Rhythms. 2008 Oct;23(5):379-86. doi: 10.1177/0748730408323089.

  PMID: 18838601 BACKGROUND

• Sasseville A, Hebert M. Using blue-green light at night and blue-blockers during the day to improves adaptation to night work: a pilot study. Prog Neuropsychopharmacol Biol Psychiatry. 2010 Oct 1;34(7):1236-42. doi: 10.1016/j.pnpbp.2010.06.027. Epub 2010 Jul 3.

  PMID: 20599459 BACKGROUND

• Sasseville A, Benhaberou-Brun D, Fontaine C, Charon MC, Hebert M. Wearing blue-blockers in the morning could improve sleep of workers on a permanent night schedule: a pilot study. Chronobiol Int. 2009 Jul;26(5):913-25. doi: 10.1080/07420520903044398.

  PMID: 19637050 BACKGROUND

• Figueiro MG, Lesniak NZ, Rea MS. Implications of controlled short-wavelength light exposure for sleep in older adults. BMC Res Notes. 2011 Sep 8;4:334. doi: 10.1186/1756-0500-4-334.

  PMID: 21902824 BACKGROUND

• Cole RJ, Smith JS, Alcala YC, Elliott JA, Kripke DF. Bright-light mask treatment of delayed sleep phase syndrome. J Biol Rhythms. 2002 Feb;17(1):89-101. doi: 10.1177/074873002129002366.

  PMID: 11837952 BACKGROUND

• Parolari A, Camera M, Alamanni F, Naliato M, Polvani GL, Agrifoglio M, Brambilla M, Biancardi C, Mussoni L, Biglioli P, Tremoli E. Systemic inflammation after on-pump and off-pump coronary bypass surgery: a one-month follow-up. Ann Thorac Surg. 2007 Sep;84(3):823-8. doi: 10.1016/j.athoracsur.2007.04.048.

  PMID: 17720383 BACKGROUND

• Clive Landis R, Murkin JM, Stump DA, Baker RA, Arrowsmith JE, De Somer F, Dain SL, Dobkowski WB, Ellis JE, Falter F, Fischer G, Hammon JW, Jonas RA, Kramer RS, Likosky DS, Paget Milsom F, Poullis M, Verrier ED, Walley K, Westaby S. Consensus statement: minimal criteria for reporting the systemic inflammatory response to cardiopulmonary bypass. Heart Surg Forum. 2010 Apr;13(2):E116-23. doi: 10.1532/HSF98.20101022.

  PMID: 20444674 BACKGROUND

• Nozohoor S, Nilsson J, Algotsson L, Sjogren J. Postoperative increase in B-type natriuretic peptide levels predicts adverse outcome after cardiac surgery. J Cardiothorac Vasc Anesth. 2011 Jun;25(3):469-75. doi: 10.1053/j.jvca.2010.07.002. Epub 2010 Sep 9.

  PMID: 20829070 BACKGROUND

• Gasparovic H, Burcar I, Kopjar T, Vojkovic J, Gabelica R, Biocina B, Jelic I. NT-pro-BNP, but not C-reactive protein, is predictive of atrial fibrillation in patients undergoing coronary artery bypass surgery. Eur J Cardiothorac Surg. 2010 Jan;37(1):100-5. doi: 10.1016/j.ejcts.2009.07.003. Epub 2009 Aug 18.

  PMID: 19692262 BACKGROUND

• Domanski MJ, Mahaffey K, Hasselblad V, Brener SJ, Smith PK, Hillis G, Engoren M, Alexander JH, Levy JH, Chaitman BR, Broderick S, Mack MJ, Pieper KS, Farkouh ME. Association of myocardial enzyme elevation and survival following coronary artery bypass graft surgery. JAMA. 2011 Feb 9;305(6):585-91. doi: 10.1001/jama.2011.99.

  PMID: 21304084 BACKGROUND

• Westaby S, Saatvedt K, White S, Katsumata T, van Oeveren W, Halligan PW. Is there a relationship between cognitive dysfunction and systemic inflammatory response after cardiopulmonary bypass? Ann Thorac Surg. 2001 Feb;71(2):667-72. doi: 10.1016/s0003-4975(00)02405-x.

  PMID: 11235725 BACKGROUND

• Fonken LK, Haim A, Nelson RJ. Dim light at night increases immune function in Nile grass rats, a diurnal rodent. Chronobiol Int. 2012 Feb;29(1):26-34. doi: 10.3109/07420528.2011.635831.

  PMID: 22217098 BACKGROUND

MeSH Terms

Conditions

Chronobiology Disorders; Inflammation

Condition Hierarchy (Ancestors)

Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Randy J Nelson, PhD

  West Virginia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James C Walton, PhD

CONTACT

3042933490; james.walton@hsc.wvu.edu

Pallavi Sharma, PhD

CONTACT

pallavi.sharma@hsc.wvu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair

Model Details: Study participants at the Heart and Vascular Institute (HVI) will be randomly assigned to the control group (goggles that allow through the full spectrum of light), or to the experimental group (goggles that filter out light in the blue range) using block randomization. With a sample size of 40 participants per group (i.e., N = 80 total).

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: October 8, 2020
• Study Start: September 20, 2021
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)