Bright Light Exposure in Surgical Patients

NCT03822949 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-05-14

No results posted yet for this study

Summary

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.

Conditions

  • Myocardial Ischemia
  • Critical Illness
  • Endothelial Dysfunction

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

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Tobias Eckle, MD, PhD · UC Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-12
Primary Completion
2026-07-31
Completion
2026-07-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822949 on ClinicalTrials.gov