Език: EN EN
← Назад към резултатите
Набира участници Не е приложимо NCT04578249

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Circadian Rhythm Disorders

Спонсор: West Virginia University

Налично на: БГ
Обобщение
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.
Описание
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 summar
Кой може да участва
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
Интервенции
Blue light-blocking goggles
OTHER
Clear goggles
OTHER
Места на провеждане 1
САЩ (1)
West Virginia University Heart and Vascular Institute
Morgantown , West Virginia
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
45 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
20.09.2021
Крайна дата
01.05.2027
Регистрационен номер
NCT04578249
Източник
clinicaltrials.gov
Запитване за медицински туризъм

Информацията е извлечена автоматично от ClinicalTrials.gov. Консултирайте се с вашия лекар преди да предприемете действия.