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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-12

Study Completion Date

2024-08-31

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.

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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.

Conditions

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Circadian Dysrhythmia Delirium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Blue light therapy

The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning.

Group Type EXPERIMENTAL

Blue light therapy

Intervention Type DEVICE

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

White light

The participants receive white light for 1 hour, between 8am to 12pm in the morning.

Group Type SHAM_COMPARATOR

White light

Intervention Type OTHER

White light is used as sham control.

Interventions

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Blue light therapy

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

Intervention Type DEVICE

White light

White light is used as sham control.

Intervention Type OTHER

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.

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes