Actively Recruiting

Phase Not Applicable
Age: 18Years - 90Years
All Genders
ID03822949

Bright Light Exposure in Patients Undergoing Non-cardiac Elective Surgery

Led by University of Colorado, Denver · Updated on 2025-05-14

70

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of intense light therapy on patients undergoing cardiac surgery and those critically ill in intensive care units. The study explores how bright light exposure may stabilize the Per2 protein in blood and tissue samples, potentially reducing heart muscle damage after surgery. It also investigates how light therapy might improve circadian rhythms and blood vessel function in critically ill patients to prevent complications like strokes and organ damage. Participants scheduled for primary sternotomy cardiac surgery will be randomly assigned to receive either bright light therapy or a dim placebo light for up to 10 days before surgery. The therapy involves using a bright light box for 30 minutes each morning between 8:30 and 9:00 AM. For ICU patients after trauma or elective surgery, intense light therapy or placebo light will be applied for 30 minutes each morning for 5 to 10 days. During the study, blood and buccal swabs will be collected, and a small piece of heart tissue will be taken during surgery for analysis. Noninvasive devices will monitor blood vessel function and circadian activity. Throughout participation, patients will undergo blood draws before and after light therapy, including measurements of Per2 levels, Troponin I, melatonin, triglycerides, and ANGPTL4. Endothelial function will be assessed using the Endo-PAT device, and circadian patterns will be tracked with an Actiwatch worn on the wrist. Light therapy will be supervised to ensure proper use. The study aims to understand whether light exposure can reduce heart injury during surgery and improve blood vessel function in critically ill patients, with monitoring continuing up to 10 days and beyond.

CONDITIONS

Brief Title

Bright Light Exposure in Surgical Patients

Who Can Participate

Age: 18Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients undergoing primary sternotomy cardiac surgery
  • Age between 18 and 90 years old
  • Patient must have sinus rhythm at the time of surgery
Not Eligible

You will not qualify if you...

  • Patients younger than 18 or older than 90 years old
  • Participation in other clinical trials within the previous 30 days
  • Pregnancy
  • Neurological conditions impairing ventilator weaning
  • Significant central nervous system disorders or irreversible conditions with over 50% six-month mortality
  • Prisoners or individuals unable to make decisions
  • History of type 2 diabetes
  • Atrial fibrillation or use of class III anti-arrhythmic drugs
  • Left ventricle ejection fraction less than 40%
  • Emergency condition patients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) between 10 to 1 days prior to surgery for blood and buccal swab collection without light therapy

Implementation

Duration - 7 days prior to surgery

Participants start using a light box device every morning from 8:30 to 9:00 AM for 7 days prior to surgery. Participants must keep the device close to their eyes and remain in place during exposure.

Daily self-administered light therapy sessions each morning for 7 days

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo cardiac surgery. Blood and tissue samples are collected on the day of surgery before anesthesia induction after one week of light or placebo therapy. A small piece of right atrial myocardium is collected during surgery for analysis.

1 visit (in-person) for surgery and sample collection

Post-operative Follow-up

Duration - Up to 10 days after surgery

Participants admitted to ICU receive daily 30-minute light therapy or placebo light each morning for 5 to 10 days. Blood samples are drawn before sunrise and after light therapy each day. Noninvasive monitoring of endothelial function and circadian patterns is performed with Endo-PAT and ActiWatch devices.

Daily visits or assessments for up to 10 days post-surgery in ICU

Trial Site Locations

Total: 1 location

1

University of Colorado Denver | Anschutz Medical Campus

Denver, Colorado, United States, 80220-3706

Actively Recruiting

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Research Team

T

Tobias Eckle, MD, PhD

N

Nick Naughton, BS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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Published Research Related To This Trial

The Circadian PER2 Enhancer Nobiletin Reverses the Deleterious Effects of Midazolam in Myocardial Ischemia and Reperfusion Injury.

Yoshimasa Oyama, Colleen Marie Bartman, Jennifer Gile...

https://pubmed.ncbi.nlm.nih.gov/30246635

Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms.

Colleen Marie Bartman, Yoshimasa Oyama, Kelley Brodsky...

https://pubmed.ncbi.nlm.nih.gov/28448534

Cardiac Per2 functions as novel link between fatty acid metabolism and myocardial inflammation during ischemia and reperfusion injury of the heart.

Stephanie Bonney, Doug Kominsky, Kelley Brodsky...

https://pubmed.ncbi.nlm.nih.gov/23977055

Adora2b-elicited Per2 stabilization promotes a HIF-dependent metabolic switch crucial for myocardial adaptation to ischemia.

Tobias Eckle, Katherine Hartmann, Stephanie Bonney...

https://pubmed.ncbi.nlm.nih.gov/22504483