Bright Light Exposure in Surgical Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

70 Participants
are divided into 4 treatment groups
Group A: Experimental: Exposed to Day lightExperimental treatment 1 intervention
Group B: Sham Comparator: Exposed to Room lightPlacebo comparator 1 intervention
Group C: Experimental: ICU Exposed to Day lightExperimental treatment 1 intervention
Group D: Sham Comparator: ICU Exposed to Room lightPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Period 2 (Per2) protein levels

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

Time frame
1-10 days

Secondary outcomes

Other outcomes

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator