Clinical trial NCT04953767: The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy
Official title: The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Circadian Dysrhythmia
Delirium
Keywords: Circadian rhythm
ICU
Acute myocardial infarction
Delirium
Light therapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 70
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of the circadian rhythm during admission by actigraphy
timeFrame: an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks
measure: Changes of the circadian rhythm during admission by heart-rate-variation-analysis
timeFrame: baseline for 48hours, and 24hours before discharge
measure: Changes of Melatonin level
timeFrame: collect saliva in the morning and at the night of Day 1 and the day of discharge
measure: Changes of Vitamin D level
timeFrame: blood sampling at Day 1 and the day of discharge
Secondary outcomes:
measure: Confusion Assessment Method for the Intensive Care Unit
timeFrame: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
measure: Intensive Care Delirium Screen Checklist
timeFrame: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Other outcomes:
Locations:
city: Taoyuan city
country: Taiwan
facility: Wei-Chih Chin
Study officials:
affiliation: Chang Gung Medical Foundation
name: Wei-Chih Chin
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
citation: 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.
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.
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.