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

August 28, 2023 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan city, Taiwan, 333423
        • Recruiting
        • Wei-Chih Chin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of the circadian rhythm during admission by actigraphy
Time Frame: an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks
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
Time Frame: baseline for 48hours, and 24hours before discharge
heart-rate-variation-analysis data
baseline for 48hours, and 24hours before discharge
Changes of Melatonin level
Time Frame: collect saliva in the morning and at the night of Day 1 and the day of discharge
Melatonin level
collect saliva in the morning and at the night of Day 1 and the day of discharge
Changes of Vitamin D level
Time Frame: blood sampling at Day 1 and the day of discharge
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
Time Frame: 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
evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks
Intensive Care Delirium Screen Checklist
Time Frame: 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
evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Principal Investigator: Wei-Chih Chin, Chang Gung Medical Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2021

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 8, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201902108A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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