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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue light therapy | Experimental | The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning. |
|
| White light | Sham Comparator | The participants receive white light for 1 hour, between 8am to 12pm in the morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue light therapy | Device | Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of the circadian rhythm during admission by actigraphy | 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 | heart-rate-variation-analysis data | baseline for 48hours, and 24hours before discharge |
| Changes of Melatonin level | Melatonin level | collect saliva in the morning and at the night of Day 1 and the day of discharge |
| Changes of Vitamin D level | Vitamin D level | blood sampling at Day 1 and the day of discharge |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks |
| Intensive Care Delirium Screen Checklist |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei-Chih Chin | Contact | +886 3 3281200 | 3836 | auaug0327@cgmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Wei-Chih Chin | Chang Gung Medical Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wei-Chih Chin | Recruiting | Taoyuan City | 333423 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26041151 | Background | 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. | |
| 26606319 | Background | 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. |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| White light | Other | White light is used as sham control. |
|
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 |
| 21511473 | Background | 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. |
| 17692522 | Background | 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. |
| 29376502 | Background | 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. |
| 19103609 | Background | 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. |
| 16616632 | Background | 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |