Recruiting

Bright Light ExposureBright Light Exposure in Surgical Patients

Sponsor:

University of Colorado, Denver

Code:

NCT03822949

Conditions

Myocardial Ischemia

Critical Illness

Endothelial Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Day Light

Placebo light

ICU Intense Light

ICU Placebo light

Study Details

Brief 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

Study ID

NCT03822949

Start date

Jul 12, 2019

Status verified date

May, 2025

Completion date

Jul 1, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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
pregnancy
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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Experimental: Exposed to Day light

Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive an intense (bright light, Square One Wake Up Light NatureBright 10,000 LUX) box. The patient will start using the light box prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of light therapy.

placebo comparator: Sham Comparator: Exposed to Room light

Patients undergoing primary sternotomy cardiac surgery: Patients will be enrolled 10 to 1 days prior to surgery and will receive a placebo/control device (dim/night light box). The patient will start using the light box 7 days prior to surgery every morning from 8.30 to 9.00 AM. Blood /buccal swabs will be collected on the day of enrollment (10 to 1 days prior to surgery) between 7 and 10 AM without any light therapy and on the day of surgery between 7 and 10 AM before anesthesia induction after one week of placebo therapy.

experimental: Experimental: ICU Exposed to Day light

Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes intense light each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device. The patient will need to keep the box as close as possible to their eyes and not walk away during the treatment period. This will be facilities by a study nurse.

placebo comparator: Sham Comparator: ICU Exposed to Room light

Patients undergoing trauma or elective surgery with ICU admission: Light therapy will consist of 30 minutes using a placebo/control device (dim/night light box) each morning for 5-10 days. Blood will be drawn before sunrise and after light therapy. Light therapy will be performed by a study nurse to ensure proper use. In addition, endothelial function and activity will be measured using the noninvasive Endo-pat and ActiWatch device.

Interventions

Day Light

Patients are exposed to daylight for up to 10 days prior to surgery

Placebo light

Patients are exposed to placebo light for up to 10 days prior to surgery

ICU Intense Light

ICU Patients are exposed to daylight for up to 10 days after surgery

ICU Placebo light

ICU Patients are exposed to placebo light for up to 10 days after surgery

Primary outcome measure

Change of Period 2 (Per2) protein levels [ Time Frame: 1-10 days ]

Central Contacts and Locations

Central contacts

Tobias Eckle, MD, PhD

7209495646 tobias.eckle@cuanschutz.edu

Nick Naughton, BS

303-724-0833 NICK.NAUGHTON@CUANSCHUTZ.EDU

Locations

University of Colorado Denver | Anschutz Medical Campus

Recruiting

Denver, Colorado, United States, 80220-3706

Contacts

Nick M Naughton, BS

303-724-0833 NICK.NAUGHTON@CUANSCHUTZ.EDU

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 14, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2025-05-14.