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Behavioural Intervention

Intense Light Therapy for Critical Illness

N/A

Recruiting

Led By Tobias Eckle, MD, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient need to be in sinus rhythm at the time of surgery

Subjects in the range of 18 - 90 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1-10 days

Awards & highlights

Study Summary

This trial will elucidate the influence of intense light therapy pretreatment in patients undergoing cardiac surgery. Hypotheses are 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. Additionally, light therapy may lead to Per2 dependent metabolic optimization in the human cardiac tissue.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the trial does not specify side effects of light therapy directly, potential risks may include discomfort from bright lights or disruption of sleep patterns due to changes in circadian rhythm.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart beats in a normal rhythm.

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I am between 18 and 90 years old.

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I am having open-heart surgery through a cut in my chest bone.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1-10 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1-10 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-10 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change of Period 2 (Per2) protein levels

Trial Design

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,836 Previous Clinical Trials

47,850,978 Total Patients Enrolled

18 Trials studying Critical Illness

21,063 Patients Enrolled for Critical Illness

University of Colorado, DenverLead Sponsor

1,734 Previous Clinical Trials

2,148,813 Total Patients Enrolled

10 Trials studying Critical Illness

9,791 Patients Enrolled for Critical Illness

Tobias Eckle, MD, PhDPrincipal InvestigatorUC Denver

Media Library

Critical Illness Research Study Groups: Experimental: Exposed to Day light, Sham Comparator: Exposed to Room light, Sham Comparator: ICU Exposed to Room light, Experimental: ICU Exposed to Day light

Critical Illness Clinical Trial 2023: ICU Intense Light Highlights & Side Effects. Trial Name: NCT03822949 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant capacity of this research endeavor?

"Affirmative. According to information published on clinicaltrials.gov, this investigation is still recruiting patients which began being sought after the 12th of July 2019 and was most recently updated on the 2nd of May 2022. The research team needs approximately 70 participants from one location for the study"

Answered by AI

Is enrollment open to participants of any age below seventy-five?

"This experiment permits entry from those aged 18 to 90. 63 clinical trials are available for youth, while 812 are open to the elderly population."

Answered by AI

Are any more participants being welcomed into this experiment?

"That is correct. Per the information posted on clinicaltrials.gov, this trial is currently recruiting patients and was first announced on July 12th 2019 before being updated lastly on May 2nd 2022. The study needs 70 participants from a single medical centre in order to proceed."

Answered by AI

Could I potentially partake in this clinical experiment?

"This research is recruiting 70 candidiates, aged between 18 and 90, who have a diagnosis of myocardial infarction. Applicants must satisfy the following requirements: undergoing primary sternotomy cardiac surgery; being in sinus rhythm during their procedure; and falling within the specified age bracket."

Answered by AI

Recent research and studies

Plos OneJournal

Intense Light-elicited Upregulation of Mir-21 Facilitates Glycolysis and Cardioprotection Through Per2-dependent Mechanisms

Bartman, Colleen Marie, Yoshimasa Oyama, Kelley Brodsky, Ludmila Khailova, Lori Walker, Michael Koeppen, and Tobias Eckle. 2017. “Intense Light-elicited Upregulation of Mir-21 Facilitates Glycolysis and Cardioprotection Through Per2-dependent Mechanisms”. Edited by Meijing Wang. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0176243.

Current Pharmaceutical DesignJournal

Circadian Micrornas in Cardioprotection

Oyama, Yoshimasa, Colleen Marie Bartman, Jennifer Gile, and Tobias Eckle. 2017. “Circadian Micrornas in Cardioprotection”. Current Pharmaceutical Design. Bentham Science Publishers Ltd.. doi:10.2174/1381612823666170707165319.

Nature MedicineJournal

Adora2b-elicited Per2 Stabilization Promotes a Hif-dependent Metabolic Switch Crucial for Myocardial Adaptation to Ischemia

Eckle, Tobias, Katherine Hartmann, Stephanie Bonney, Susan Reithel, Michel Mittelbronn, Lori A Walker, Brian D Lowes, et al.. 2012. “Adora2b-elicited Per2 Stabilization Promotes a Hif-dependent Metabolic Switch Crucial for Myocardial Adaptation to Ischemia”. Nature Medicine. Springer Science and Business Media LLC. doi:10.1038/nm.2728.

Current Pharmaceutical DesignJournal