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

Chang Gung Memorial Hospital70 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Circadian Dysrhythmia Delirium

Interventions

Blue light therapyDEVICE

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

White lightOTHER

White light is used as sham control.

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Wei-Chih Chin

Taoyuan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

Changes of the circadian rhythm during admission by actigraphy

Actigraphy data

Time frame: 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

Time frame: baseline for 48hours, and 24hours before discharge

Changes of Melatonin level

Melatonin level

Time frame: 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

Time frame: blood sampling at Day 1 and the day of discharge

Secondary Outcomes

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

Time frame: 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

Time frame: evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks

Central Contacts

Wei-Chih Chin

CONTACT

+886 3 3281200 auaug0327@cgmh.org.tw

Data from ClinicalTrials.gov

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