Bright Light Exposure in Surgical Patients

NCT03822949 | Recruiting DMC FDA Device

• 2 other identifiers: 18-0904R01HL122472
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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

Outcome Measures

Primary Outcomes (1)

• Change of Period 2 (Per2) protein levels

  Measure of Per2 protein levels related to daylight exposure vs. room light exposure.

  1-10 days

Study Arms (4)

Experimental: Exposed to Day light

EXPERIMENTAL

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.

Device: Day Light

Sham Comparator: Exposed to Room light

PLACEBO COMPARATOR

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.

Device: Placebo light

Experimental: ICU Exposed to Day light

EXPERIMENTAL

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.

Device: ICU Intense Light

Sham Comparator: ICU Exposed to Room light

PLACEBO COMPARATOR

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.

Device: ICU Placebo light

Interventions

Day Light DEVICE

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

Experimental: Exposed to Day light

Placebo light DEVICE

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

Sham Comparator: Exposed to Room light

ICU Intense Light DEVICE

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

Experimental: ICU Exposed to Day light

ICU Placebo light DEVICE

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

Sham Comparator: ICU Exposed to Room light

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Colorado Denver | Anschutz Medical Campus

Denver, Colorado, 80220-3706, United States

RECRUITING

Related Publications (7)

• Bartman CM, Oyama Y, Eckle T. Daytime variations in perioperative myocardial injury. Lancet. 2018 May 26;391(10135):2104. doi: 10.1016/S0140-6736(18)30797-9. Epub 2018 May 24. No abstract available.

  PMID: 29856340 BACKGROUND

• Oyama Y, Bartman CM, Gile J, Eckle T. Circadian MicroRNAs in Cardioprotection. Curr Pharm Des. 2017;23(25):3723-3730. doi: 10.2174/1381612823666170707165319.

  PMID: 28699517 BACKGROUND

• Bonney S, Hughes K, Harter PN, Mittelbronn M, Walker L, Eckle T. Cardiac period 2 in myocardial ischemia: clinical implications of a light dependent protein. Int J Biochem Cell Biol. 2013 Mar;45(3):667-71. doi: 10.1016/j.biocel.2012.12.022. Epub 2013 Jan 3.

  PMID: 23291353 BACKGROUND

• Oyama Y, Bartman CM, Gile J, Sehrt D, Eckle T. The Circadian PER2 Enhancer Nobiletin Reverses the Deleterious Effects of Midazolam in Myocardial Ischemia and Reperfusion Injury. Curr Pharm Des. 2018;24(28):3376-3383. doi: 10.2174/1381612824666180924102530.

  PMID: 30246635 RESULT

• Bartman CM, Oyama Y, Brodsky K, Khailova L, Walker L, Koeppen M, Eckle T. Intense light-elicited upregulation of miR-21 facilitates glycolysis and cardioprotection through Per2-dependent mechanisms. PLoS One. 2017 Apr 27;12(4):e0176243. doi: 10.1371/journal.pone.0176243. eCollection 2017.

  PMID: 28448534 RESULT

• Bonney S, Kominsky D, Brodsky K, Eltzschig H, Walker L, Eckle T. Cardiac Per2 functions as novel link between fatty acid metabolism and myocardial inflammation during ischemia and reperfusion injury of the heart. PLoS One. 2013 Aug 20;8(8):e71493. doi: 10.1371/journal.pone.0071493. eCollection 2013.

  PMID: 23977055 RESULT

• Eckle T, Hartmann K, Bonney S, Reithel S, Mittelbronn M, Walker LA, Lowes BD, Han J, Borchers CH, Buttrick PM, Kominsky DJ, Colgan SP, Eltzschig HK. Adora2b-elicited Per2 stabilization promotes a HIF-dependent metabolic switch crucial for myocardial adaptation to ischemia. Nat Med. 2012 Apr 15;18(5):774-82. doi: 10.1038/nm.2728.

  PMID: 22504483 RESULT

MeSH Terms

Conditions

Myocardial Ischemia; Critical Illness

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tobias Eckle, MD, PhD

  UC Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tobias Eckle, MD, PhD

CONTACT

7209495646; tobias.eckle@cuanschutz.edu

Nick Naughton, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 30, 2019
• Study Start: July 12, 2019
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)