Intense Light Therapy for Critical Illness

Overseen By Nick Naughton, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Class III anti-arrhythmics

Disqualifiers: Diabetes, Atrial fibrillation, CNS disorders, others

Compensation: Varies

Number of Visits: 1

Duration: 5-10 days

70 Participants Needed

What You Need to Know Before You Apply

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 6 7}

Who Is on the Research Team?

Tobias Eckle, MD, PhD

Principal Investigator

UC Denver

Are You a Good Fit for This Trial?

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 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.

My heart's pumping ability is below 40%.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Day Light
• ICU Intense Light
• ICU Placebo light
• Placebo light

Trial Overview The 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.

How Is the Trial Designed?

Group I: Experimental: ICU Exposed to Day light Experimental Treatment 1 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 light Experimental Treatment 1 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 light Placebo Group 1 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 light Placebo Group 1 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.

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

High-intensity blue-light phototherapy was found to be twice as effective as standard daylight phototherapy in reducing bilirubin levels in 3802 infants, with no treatment failures reported for the high-intensity method.

While high-intensity phototherapy required more clinical monitoring and was more challenging for nursing staff, it is recommended for infants with rapidly increasing bilirubin levels due to its superior efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of "high-intensity" blue-light and "standard" daylight phototherapy for non-haemolytic hyperbilirubinaemia. Tan, KL., Lim, GC., Boey, KW.[2019]

In a study involving 17 ICU patients, light exposure was continuously monitored for over 24 hours, revealing that ambient light levels were consistently low, peaking at only 64.1 lux in the late morning.

There was no significant correlation between light exposure and melatonin secretion, suggesting that inadequate light during the day in the ICU may disrupt patients' circadian rhythms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abnormal environmental light exposure in the intensive care environment. Fan, EP., Abbott, SM., Reid, KJ., et al.[2018]

A study involving 734 ICU patients found that high-intensity dynamic light application (DLA) did not significantly reduce the incidence of ICU-acquired delirium compared to normal lighting, with 38% of DLA patients and 33% of control patients developing delirium.

The study was terminated early due to an interim analysis showing futility, suggesting that DLA alone may not be effective, and highlighting the need for further research on bright-light therapy as part of a broader treatment strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic light application therapy to reduce the incidence and duration of delirium in intensive-care patients: a randomised controlled trial. Simons, KS., Laheij, RJ., van den Boogaard, M., et al.[2022]

Between 2008 and 2013, the irradiance levels of phototherapy devices in Dutch neonatal intensive care units significantly increased, with median irradiance for overhead devices rising from 9.7 to 16.4 μW cm-2 nm-1 and for underneath devices from 6.8 to 22.3 μW cm-2 nm-1.

The improvement in irradiance is attributed to the introduction of more effective LED-based devices and a reduction in the distance between the devices and infants, leading to a higher percentage of devices meeting the minimal recommended irradiance levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Irradiance levels of phototherapy devices: a national study in Dutch neonatal intensive care units. Hulzebos, CV., Van't Klooster, SJ., Lorenz, K., et al.[2019]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Let there be light and darkness: findings from a prestudy concerning cycled light in the intensive care unit environment. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Prospective Randomized Controlled Pilot Study of High-Intensity Lightbox Phototherapy to Prevent ICU-Acquired Delirium Incidence. [2021]

3. England pubmed.ncbi.nlm.nih.gov

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]

4. Norway pubmed.ncbi.nlm.nih.gov

Efficacy of "high-intensity" blue-light and "standard" daylight phototherapy for non-haemolytic hyperbilirubinaemia. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Abnormal environmental light exposure in the intensive care environment. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Dynamic light application therapy to reduce the incidence and duration of delirium in intensive-care patients: a randomised controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Irradiance levels of phototherapy devices: a national study in Dutch neonatal intensive care units. [2019]