70 Participants Needed

Intense Light Therapy for Critical Illness

TE
NN
Overseen ByNick Naughton, BS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Colorado, Denver

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are using a class III anti-arrhythmic drug, you may not be eligible to participate.

What data supports the effectiveness of intense light therapy for critical illness?

Research shows that bright light therapy can improve sleep patterns and cognitive function in non-critically ill patients, but its benefits in the ICU setting are not clearly established. A study found no significant difference in ICU delirium incidence between patients receiving bright light therapy and those under standard lighting.12345

How does Intense Light Therapy differ from other treatments for ICU-acquired delirium?

Intense Light Therapy is unique because it uses bright light exposure to help realign the body's internal clock (circadian rhythm), which may reduce the risk of delirium in ICU patients. Unlike other treatments that might involve medication, this therapy focuses on environmental light adjustments to potentially improve patient outcomes.12367

Research Team

TE

Tobias Eckle, MD, PhD

Principal Investigator

UC Denver

Eligibility Criteria

This trial is for patients aged 18-90 undergoing primary sternotomy cardiac surgery who are in sinus rhythm. Excluded are those in emergency conditions, pregnant, prisoners, decision-impaired individuals, with significant CNS disorders or comorbidities indicating high mortality within six months, under 18 or over 90 years old, with type 2 diabetes, atrial fibrillation or on class III anti-arrhythmic drugs.

Inclusion Criteria

My heart beats in a normal rhythm.
I am between 18 and 90 years old.
I am having open-heart surgery through a cut in my chest bone.

Exclusion Criteria

You have serious brain or nerve disorders, or other health conditions that are not reversible and have a high chance of causing death within six months.
I am not a prisoner and can make my own decisions.
I am between 18 and 90 years old.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-10 days
1 visit (in-person)

Pre-treatment

Participants receive intense light therapy or placebo for 7 days prior to surgery

7 days
Daily sessions (in-person)

Treatment

Participants undergo cardiac surgery with continued monitoring and light therapy in ICU

5-10 days
Daily sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

72 hours post-surgery
Blood sample collection

Treatment Details

Interventions

  • Day Light
  • ICU Intense Light
  • ICU Placebo light
  • Placebo light
Trial OverviewThe study tests if intense light exposure before cardiac surgery can stabilize circadian rhythms and improve vessel function to prevent severe complications like delirium and heart attacks. Participants will be exposed to different intensities of light therapy and effects measured using human tissue samples and Troponin I levels post-surgery.
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: ICU Exposed to Day lightExperimental Treatment1 Intervention
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.
Group II: Experimental: Exposed to Day lightExperimental Treatment1 Intervention
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.
Group III: Sham Comparator: Exposed to Room lightPlacebo Group1 Intervention
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.
Group IV: Sham Comparator: ICU Exposed to Room lightPlacebo Group1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials
1,842
Recruited
3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Findings from Research

Cycled light in an intensive care unit may improve health outcomes for preterm infants compared to dim or non-cycled light, suggesting its potential therapeutic benefits.
Patients in a specially designed lighting environment reported a more positive experience compared to those in a standard room, indicating that lighting interventions can enhance the overall atmosphere in intensive care settings.
Let there be light and darkness: findings from a prestudy concerning cycled light in the intensive care unit environment.Engwall, M., Fridh, I., Bergbom, I., et al.[2018]
In a study involving ICU patients, daily bright light therapy (BLT) at 10,000 lux for 30 minutes did not significantly reduce the incidence or duration of ICU-acquired delirium compared to standard hospital lighting, with both groups showing similar delirium rates (18% vs. 17.5%).
The findings suggest that while BLT has been effective in non-critically ill patients, its application in the ICU setting may require further investigation, particularly regarding the timing and management of light exposure to better address the impact of disturbed circadian rhythms on delirium.
Prospective Randomized Controlled Pilot Study of High-Intensity Lightbox Phototherapy to Prevent ICU-Acquired Delirium Incidence.Zhang, KS., Pelleg, T., Hussain, S., et al.[2021]
In a pilot study of ICU patients, the median nocturnal light exposure was found to be only 1.5 lux, significantly below the recommended standard of 20 lux, which may affect circadian rhythms and patient outcomes.
There was a positive correlation between the severity of patient illness and the maximum light exposure, indicating that sicker patients experienced higher light levels, which could have implications for their recovery and length of stay in the ICU.
CANDLE: The critical analysis of the nocturnal distribution of light exposure - A prospective pilot study quantifying the nocturnal light intensity on a critical care unit.Craig, T., Mathieu, S.[2020]

References

Let there be light and darkness: findings from a prestudy concerning cycled light in the intensive care unit environment. [2018]
Prospective Randomized Controlled Pilot Study of High-Intensity Lightbox Phototherapy to Prevent ICU-Acquired Delirium Incidence. [2021]
CANDLE: The critical analysis of the nocturnal distribution of light exposure - A prospective pilot study quantifying the nocturnal light intensity on a critical care unit. [2020]
Efficacy of "high-intensity" blue-light and "standard" daylight phototherapy for non-haemolytic hyperbilirubinaemia. [2019]
Abnormal environmental light exposure in the intensive care environment. [2018]
Dynamic light application therapy to reduce the incidence and duration of delirium in intensive-care patients: a randomised controlled trial. [2022]
Irradiance levels of phototherapy devices: a national study in Dutch neonatal intensive care units. [2019]