Circadian Rhythm DisordersNCT04578249
Effects of Blocking Blue Light at Night Post CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
A study testing Blue light-blocking goggles and Clear goggles in people with Circadian Rhythm Disorders, run by West Virginia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Circadian Rhythm Disorders
- What is being tested?
- Blue light-blocking goggles and Clear goggles
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Sep 2021to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pallavi Sharma, PhD contact
United States1 site, 1 recruiting
- Recruiting
West Virginia University Heart and Vascular Institute
Morgantown, West Virginia, 26506
James C. Walton, PhD, 304.293.3490, james.walton@hsc.wvu.edu
Pallavi Sharma, PhD, pallavi.sharma@hsc.wvu.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Circadian Rhythm Disorders
- Being tested
- Blue light-blocking goggles, Clear goggles
- Keywords
- CABG, coronary artery bypass graft, light at night, dim light at night, inflammation, cognition, blue light
- Medical subject headings
- Chronobiology Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue light-blocking gogglesOther
Also called Uvex (Honeywell, USA)
Participants will be randomly assigned to one of the two intervention groups.
Clear gogglesOther
Also called Uvex (Honeywell, USA)
Participants will be randomly assigned to one of the two intervention groups.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Blue light-blocking goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 30 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start20 Sep 2021
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Circadian Rhythm DisordersStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randy Nelson, West Virginia University
- Investigators
- Randy J Nelson, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04578249
- Sponsor's protocol ID
- 2002905562
- Status last verified
- Apr 2026
- First submitted
- 21 Jul 2020
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 7733754Inouye 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.
PubMed 2240918Joyeux-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.
PubMed 21929528Brainard 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.
PubMed 18838601Sasseville 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.
PubMed 20599459Sasseville 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.
PubMed 19637050Figueiro 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.
PubMed 21902824Cole 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.
PubMed 11837952Parolari 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.
PubMed 17720383Clive 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.
PubMed 20444674Nozohoor 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.
PubMed 20829070Gasparovic 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.
PubMed 19692262Domanski 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.
PubMed 21304084Westaby 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.
PubMed 11235725Fonken 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.
PubMed 22217098
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blocking Blue Light at Night on Patient Outcomes After Elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH
- ClinicalTrials.gov ID
- NCT04578249
- Acronym / sponsor ID
- 2002905562
- Conditions
- Circadian Rhythm Disorders
- Keywords
- CABG, coronary artery bypass graft, light at night, dim light at night, inflammation, cognition, blue light
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Clear goggles | Placebo comparator | Other: Clear gogglesPatients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given clear goggles to wear at nighttime. |
| Blue-light blocking goggles | Experimental | Other: Blue light-blocking gogglesPatients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given blue-light blocking goggles to wear at nighttime. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Both men and women that are undergoing elective (non-emergency)
- No history of diagnosed psychiatric disorders or organ failure
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue light-blocking gogglesAlso: Uvex (Honeywell, USA)Participants will be randomly assigned to one of the two intervention groups. | Other | Blue-light blocking goggles |
| Clear gogglesAlso: Uvex (Honeywell, USA)Participants will be randomly assigned to one of the two intervention groups. | Other | Clear goggles |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 7733754Murkin 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.
- Background: PubMed 2240918Inouye 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.
- Background: PubMed 21929528Joyeux-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.
- Background: PubMed 18838601Brainard 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pallavi Sharma, PhD contact
Randy J Nelson, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue light-blocking goggles and Clear goggles in people with Circadian Rhythm Disorders, run by West Virginia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James C Walton, PhD (3042933490, james.walton@hsc.wvu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline serum cytokine profile (time frame: 5 days post-surgery). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04578249, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.