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

Not Applicable

Recruiting

• Conditions: Circadian Dysrhythmia; Delirium
• Interventions: Other: White light; Device: Blue light therapy

• Registration Number: NCT04953767
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Study Timeline

• Study Start: 2021-05-12
• Study First Submitted: 2021-06-21
• Study First Submitted QC: 2021-06-28
• Study First Posted: 2021-07-08
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
White light	White light	The participants receive white light for 1 hour, between 8am to 12pm in the morning.
Blue light therapy	Blue light therapy	The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning.

Primary Outcome Measures

Name	Time	Method
Changes of the circadian rhythm during admission by heart-rate-variation-analysis	baseline for 48hours, and 24hours before discharge	heart-rate-variation-analysis data
Changes of Melatonin level	collect saliva in the morning and at the night of Day 1 and the day of discharge	Melatonin level
Changes of the circadian rhythm during admission by actigraphy	an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks	Actigraphy data
Changes of Vitamin D level	blood sampling at Day 1 and the day of discharge	Vitamin D level

Secondary Outcome Measures

Name	Time	Method
Confusion Assessment Method for the Intensive Care Unit	evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks	Evaluation of delirium and its severity, score range 0-7, and score 0-2 no delirium, 3-5 mild to moderate, 6-7 severe
Intensive Care Delirium Screen Checklist	evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks	Evaluation of delirium and its severity, score range 0-8, and score 4-8 suspected delirium

Trial Locations

Locations (1)

Wei-Chih Chin; 🇨🇳 Taoyuan city, Taiwan