The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy
Primary Purpose
Circadian Dysrhythmia, Delirium
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Blue light therapy
White light
Sponsored by
About this trial
This is an interventional treatment trial for Circadian Dysrhythmia focused on measuring Circadian rhythm, ICU, Acute myocardial infarction, Delirium, Light therapy
Eligibility Criteria
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.
Sites / Locations
- Wei-Chih ChinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Blue light therapy
White light
Arm Description
The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning.
The participants receive white light for 1 hour, between 8am to 12pm in the morning.
Outcomes
Primary Outcome Measures
Changes of the circadian rhythm during admission by actigraphy
Actigraphy data
Changes of the circadian rhythm during admission by heart-rate-variation-analysis
heart-rate-variation-analysis data
Changes of Melatonin level
Melatonin level
Changes of Vitamin D level
Vitamin D level
Secondary Outcome Measures
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
Intensive Care Delirium Screen Checklist
Evaluation of delirium and its severity, score range 0-8, and score 4-8 suspected delirium
Full Information
NCT ID
NCT04953767
First Posted
June 21, 2021
Last Updated
August 28, 2023
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04953767
Brief Title
The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy
Official Title
The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 12, 2021 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Circadian Dysrhythmia, Delirium
Keywords
Circadian rhythm, ICU, Acute myocardial infarction, Delirium, Light therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blue light therapy
Arm Type
Experimental
Arm Description
The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning.
Arm Title
White light
Arm Type
Sham Comparator
Arm Description
The participants receive white light for 1 hour, between 8am to 12pm in the morning.
Intervention Type
Device
Intervention Name(s)
Blue light therapy
Intervention Description
Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.
Intervention Type
Other
Intervention Name(s)
White light
Intervention Description
White light is used as sham control.
Primary Outcome Measure Information:
Title
Changes of the circadian rhythm during admission by actigraphy
Description
Actigraphy data
Time Frame
an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks
Title
Changes of the circadian rhythm during admission by heart-rate-variation-analysis
Description
heart-rate-variation-analysis data
Time Frame
baseline for 48hours, and 24hours before discharge
Title
Changes of Melatonin level
Description
Melatonin level
Time Frame
collect saliva in the morning and at the night of Day 1 and the day of discharge
Title
Changes of Vitamin D level
Description
Vitamin D level
Time Frame
blood sampling at Day 1 and the day of discharge
Secondary Outcome Measure Information:
Title
Confusion Assessment Method for the Intensive Care Unit
Description
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
Title
Intensive Care Delirium Screen Checklist
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei-Chih Chin
Phone
+886 3 3281200
Ext
3836
Email
auaug0327@cgmh.org.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Chih Chin
Organizational Affiliation
Chang Gung Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wei-Chih Chin
City
Taoyuan city
ZIP/Postal Code
333423
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei-Chih Chin
Phone
+886 3 3281200
Ext
3836
Email
auaug0327@cgmh.org.tw
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26041151
Citation
Salluh JI, Wang H, Schneider EB, Nagaraja N, Yenokyan G, Damluji A, Serafim RB, Stevens RD. Outcome of delirium in critically ill patients: systematic review and meta-analysis. BMJ. 2015 Jun 3;350:h2538. doi: 10.1136/bmj.h2538.
Results Reference
background
PubMed Identifier
26606319
Citation
van Maanen A, Meijer AM, van der Heijden KB, Oort FJ. The effects of light therapy on sleep problems: A systematic review and meta-analysis. Sleep Med Rev. 2016 Oct;29:52-62. doi: 10.1016/j.smrv.2015.08.009. Epub 2015 Sep 9.
Results Reference
background
PubMed Identifier
21511473
Citation
Ono H, Taguchi T, Kido Y, Fujino Y, Doki Y. The usefulness of bright light therapy for patients after oesophagectomy. Intensive Crit Care Nurs. 2011 Jun;27(3):158-66. doi: 10.1016/j.iccn.2011.03.003. Epub 2011 Apr 21.
Results Reference
background
PubMed Identifier
17692522
Citation
Taguchi T, Yano M, Kido Y. Influence of bright light therapy on postoperative patients: a pilot study. Intensive Crit Care Nurs. 2007 Oct;23(5):289-97. doi: 10.1016/j.iccn.2007.04.004. Epub 2007 Aug 9.
Results Reference
background
PubMed Identifier
29376502
Citation
Oh J, Cho D, Park J, Na SH, Kim J, Heo J, Shin CS, Kim JJ, Park JY, Lee B. Prediction and early detection of delirium in the intensive care unit by using heart rate variability and machine learning. Physiol Meas. 2018 Mar 27;39(3):035004. doi: 10.1088/1361-6579/aaab07.
Results Reference
background
PubMed Identifier
19103609
Citation
Osse RJ, Tulen JH, Hengeveld MW, Bogers AJ. Screening methods for delirium: early diagnosis by means of objective quantification of motor activity patterns using wrist-actigraphy. Interact Cardiovasc Thorac Surg. 2009 Mar;8(3):344-8; discussion 348. doi: 10.1510/icvts.2008.192278. Epub 2008 Dec 22.
Results Reference
background
PubMed Identifier
16616632
Citation
Papaioannou VE, Maglaveras N, Houvarda I, Antoniadou E, Vretzakis G. Investigation of altered heart rate variability, nonlinear properties of heart rate signals, and organ dysfunction longitudinally over time in intensive care unit patients. J Crit Care. 2006 Mar;21(1):95-103; discussion 103-4. doi: 10.1016/j.jcrc.2005.12.007.
Results Reference
background
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The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy
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