The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy

Delirium Clinical Trial

Official title:

The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04953767
• Other study ID #: 201902108A3
• Status: Recruiting
• Phase: N/A
• Start date: May 12, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Chang Gung Memorial Hospital
• Contact: Wei-Chih Chin
• Phone: +886 3 3281200
• Email: auaug0327[@]cgmh.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

By using subjective and objective measurements, the investigators monitor the change of circadian rhythm in Intensive Care Unit (ICU) patients with acute myocardial infarction and the effect of light therapy.

Description:

The investigators include 70 patients who are admitted to coronary care unit due to coronary artery disease, with severity between Killip I-III and age between 35-85. Participants are randomly assigned to 2 groups, the experimental group (blue light) and the placebo group (white light). Both groups receive light therapy or white light daily between 8am to 12pm. The investigators use actigraphy and heart rate variation analysis, and check melatonin level as objective measurements. The investigators use delirium scales to evaluate delirium and its severity. The light therapy is stopped once a participant is diagnosed of delirium or transferred, and the investigators keep following participants until discharge to evaluate the prognosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis for admission is acute myocardial infarction with severity between Killip I-III.
• Age is between 35-85.
• Participants who are willing to participate in the study and sign the informed consent.

Exclusion Criteria:

• Using sedative hypnotic drugs.
• Blindness or severe cataract.
• Neurological diseases such as epilepsy, brain injury, or stroke.
• Severe mental disorder such as major depressive disorder, bipolar disorder, schizophrenia, intellectual disability or substance use disorders.
• Unable to communicate.
• Participants who are unwilling to participate in the study or refuse to sign the informed consent.
• Participants who are not suitable to include in this study, evaluate by PI or Co-PI.

Related Conditions & MeSH terms

• Circadian Dysrhythmia
• Delirium

Intervention

Device:
• Blue light therapy
Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.

Other:
• White light
White light is used as sham control.

Locations

Country	Name	City	State
Taiwan	Wei-Chih Chin	Taoyuan city

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (7)

Oh J, Cho D, Park J, Na SH, Kim J, Heo J, Shin CS, Kim JJ, Park JY, Lee B. Prediction and early detection of delirium in the intensive care unit by using heart rate variability and machine learning. Physiol Meas. 2018 Mar 27;39(3):035004. doi: 10.1088/1361-6579/aaab07. — View Citation

Ono H, Taguchi T, Kido Y, Fujino Y, Doki Y. The usefulness of bright light therapy for patients after oesophagectomy. Intensive Crit Care Nurs. 2011 Jun;27(3):158-66. doi: 10.1016/j.iccn.2011.03.003. Epub 2011 Apr 21. — View Citation

Osse RJ, Tulen JH, Hengeveld MW, Bogers AJ. Screening methods for delirium: early diagnosis by means of objective quantification of motor activity patterns using wrist-actigraphy. Interact Cardiovasc Thorac Surg. 2009 Mar;8(3):344-8; discussion 348. doi: 10.1510/icvts.2008.192278. Epub 2008 Dec 22. — View Citation

Papaioannou VE, Maglaveras N, Houvarda I, Antoniadou E, Vretzakis G. Investigation of altered heart rate variability, nonlinear properties of heart rate signals, and organ dysfunction longitudinally over time in intensive care unit patients. J Crit Care. 2006 Mar;21(1):95-103; discussion 103-4. doi: 10.1016/j.jcrc.2005.12.007. — View Citation

Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538. — View Citation

Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. doi: 10.1016/j.iccn.2007.04.004. Epub 2007 Aug 9. — View Citation

van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of the circadian rhythm during admission by actigraphy	Actigraphy data	an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks
Primary	Changes of the circadian rhythm during admission by heart-rate-variation-analysis	heart-rate-variation-analysis data	baseline for 48hours, and 24hours before discharge
Primary	Changes of Melatonin level	Melatonin level	collect saliva in the morning and at the night of Day 1 and the day of discharge
Primary	Changes of Vitamin D level	Vitamin D level	blood sampling at Day 1 and the day of discharge
Secondary	Confusion Assessment Method for the Intensive Care Unit	Evaluation of delirium and its severity, score range 0-7, and score 0-2 no delirium, 3-5 mild to moderate, 6-7 severe	evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Secondary	Intensive Care Delirium Screen Checklist	Evaluation of delirium and its severity, score range 0-8, and score 4-8 suspected delirium	evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks