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Clinical Trials/NCT04953767
NCT04953767RecruitingNot Applicable

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

Chang Gung Memorial Hospital2 sites in 1 country70 target enrollmentStarted: May 12, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
70
Locations
2
Primary Endpoint
Changes of the circadian rhythm during admission by heart-rate-variation-analysis

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
35 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Diagnosis for admission is acute myocardial infarction with severity between Killip I-III.
  • Age is between 35-
  • 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.

Outcomes

Primary Outcomes

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

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

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

Changes of Vitamin D level

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

Vitamin D level

Secondary Outcomes

  • Confusion Assessment Method for the Intensive Care Unit(evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks)
  • Intensive Care Delirium Screen Checklist(evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks)

Investigators

Sponsor
Chang Gung Memorial Hospital
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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