Bright Light Exposure in Surgical Patients

Part of paid clinical trials in Denver, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03822949
Status
Recruiting
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Conditions

  • Critical Illness
  • Endothelial Dysfunction
  • Myocardial Ischemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Day Light — DEVICE
    Patients are exposed to daylight for up to 10 days prior to surgery
  • Placebo light — DEVICE
    Patients are exposed to placebo light for up to 10 days prior to surgery
  • ICU Intense Light — DEVICE
    ICU Patients are exposed to daylight for up to 10 days after surgery
  • ICU Placebo light — DEVICE
    ICU Patients are exposed to placebo light for up to 10 days after surgery

Study Details

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.

Key Dates

Start date
Jul 12, 2019
Status verified
May 2025
Primary completion
Jul 31, 2026
Completion
Jul 1, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Denver | Anschutz Medical CampusDenverColorado80220-3706
Nick M Naughton, BS
[email protected]
303-724-0833

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By research site
University of Colorado Denver | Anschutz Medical Campus· Denver, CO

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