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

NCT04953767 | Unknown DMC

• 1 other identifier: 201902108A3
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Circadian Dysrhythmia; Delirium

Keywords

Circadian rhythm; ICU; Acute myocardial infarction; Delirium; Light therapy

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Blue light therapy

EXPERIMENTAL

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

Device: Blue light therapy

White light

SHAM COMPARATOR

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

Other: White light

Interventions

Blue light therapy DEVICE

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

Blue light therapy

White light OTHER

White light is used as sham control.

White light

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Wei-Chih Chin

Taoyuan, 333423, Taiwan

RECRUITING

Related Publications (7)

• 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.

  PMID: 26041151 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.

  PMID: 26606319 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.

  PMID: 21511473 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.

  PMID: 17692522 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.

  PMID: 29376502 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.

  PMID: 19103609 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.

  PMID: 16616632 BACKGROUND

MeSH Terms

Conditions

Delirium

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Wei-Chih Chin

  Chang Gung Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei-Chih Chin

CONTACT

+886 3 3281200; auaug0327@cgmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: July 8, 2021
• Study Start: May 12, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)