NCT03822949 · University of Colorado, Denver
Bright Light Exposure in Surgical Patients
What this study is about
1. Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery.
View original scientific description
1. Elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. We hypothesize that intense light exposure is associated with the peripheral stabilization of Per2 in human buccal swabs and plasma samples before surgery and with a decrease of Troponin I levels after surgery. In addition, we hypothesize that light therapy leads to Per2 dependent metabolic optimization in the human cardiac tissue. Therefore, a small piece of human heart tissue from the right atrium will be collected during cardiac cannulation, which will be otherwise discarded. 2. Critical illness (being in the intensive care unit) results in circadian malfunction and vessels not working. Vessel function is controlled by the body's circadian clock. Intense light boosts the circadian clock and the vessel function in animal studies. Vessels not working well in critical ill patients results in a myriad of severe diseases (delirium, stroke, heart attack, organ damage etc). Thus we will test if intense light can be used to boost the circadian clock and the associated vessel function in critical ill patients.
Interventions
DEVICE
Day Light
Patients are exposed to daylight for up to 10 days prior to surgery
DEVICE
Placebo light
Patients are exposed to placebo light for up to 10 days prior to surgery
DEVICE
ICU Intense Light
ICU Patients are exposed to daylight for up to 10 days after surgery
DEVICE
ICU Placebo light
ICU Patients are exposed to placebo light for up to 10 days after surgery
Primary outcome measures
Change of Period 2 (Per2) protein levels
Time frame: 1-10 days
Measure of Per2 protein levels related to daylight exposure vs. room light exposure.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients undergoing primary sternotomy cardiac surgery
- Subjects in the range of 18 - 90 years old .
- Patient need to be in sinus rhythm at the time of surgery.
Exclusion criteria
- patients \<18 or \>90 years old
- participation in other clinical trials within the previous 30 days
- neurological conditions that could impair weaning from ventilator support
- significant CNS disorders or comorbid irreversible conditions with a six-month mortality rate more than 50 percent
- prisoners, or subjects with altered capabilities to make decision will be enrolled
- medical history of type 2 diabetes
- patients with atrial fibrillation or use of class III anti-arhythmic drug
- patients with a left ventricle ejection fraction \< 40%
- patient in emergency condition
Where
- Denver, Colorado
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2025 · Source of record for eligibility and locations