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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Circadian Dysrhythmia, Delirium

Intervention / Treatment
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* Device: Blue light therapy
* Other: White light


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blue light therapy<br>The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning. | Device: Blue light therapy<br>* Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.<br>|
| Sham Comparator: White light<br>The participants receive white light for 1 hour, between 8am to 12pm in the morning. | Other: White light<br>* White light is used as sham control.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Changes of the circadian rhythm during admission by heart-rate-variation-analysis | heart-rate-variation-analysis data | baseline for 48hours, and 24hours before discharge | 
| Changes of Melatonin level | Melatonin level | collect saliva in the morning and at the night of Day 1 and the day of discharge | 
| Changes of Vitamin D level | Vitamin D level | blood sampling at Day 1 and the day of discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute myocardial infarction, Delirium, Light therapy, Circadian rhythm, ICU