Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2025-12-25 @ 10:37 PM
Study NCT ID:
NCT04953767
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2021-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010789', 'term': 'Phototherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of the circadian rhythm during admission by actigraphy', 'timeFrame': 'an average of 2 weeks of continuous monitoring since baseline till discharge, up to 4 weeks', 'description': 'Actigraphy data'}, {'measure': 'Changes of the circadian rhythm during admission by heart-rate-variation-analysis', 'timeFrame': 'baseline for 48hours, and 24hours before discharge', 'description': 'heart-rate-variation-analysis data'}, {'measure': 'Changes of Melatonin level', 'timeFrame': 'collect saliva in the morning and at the night of Day 1 and the day of discharge', 'description': 'Melatonin level'}, {'measure': 'Changes of Vitamin D level', 'timeFrame': 'blood sampling at Day 1 and the day of discharge', 'description': 'Vitamin D level'}], 'secondaryOutcomes': [{'measure': 'Confusion Assessment Method for the Intensive Care Unit', 'timeFrame': 'evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks', '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'}, {'measure': 'Intensive Care Delirium Screen Checklist', 'timeFrame': 'evaluate daily since baseline to discharge, for an average of 2 weeks, up to 4 weeks', 'description': 'Evaluation of delirium and its severity, score range 0-8, and score 4-8 suspected delirium'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Circadian rhythm', 'ICU', 'Acute myocardial infarction', 'Delirium', 'Light therapy'], 'conditions': ['Circadian Dysrhythmia', 'Delirium']}, 'referencesModule': {'references': [{'pmid': '26041151', 'type': 'BACKGROUND', '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.'}, {'pmid': '26606319', 'type': 'BACKGROUND', '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.'}, {'pmid': '21511473', 'type': 'BACKGROUND', '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.'}, {'pmid': '17692522', 'type': 'BACKGROUND', '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.'}, {'pmid': '29376502', 'type': 'BACKGROUND', '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.'}, {'pmid': '19103609', 'type': 'BACKGROUND', '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.'}, {'pmid': '16616632', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis for admission is acute myocardial infarction with severity between Killip I-III.\n* Age is between 35-85.\n* Participants who are willing to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Using sedative hypnotic drugs.\n* Blindness or severe cataract.\n* Neurological diseases such as epilepsy, brain injury, or stroke.\n* Severe mental disorder such as major depressive disorder, bipolar disorder, schizophrenia, intellectual disability or substance use disorders.\n* Unable to communicate.\n* Participants who are unwilling to participate in the study or refuse to sign the informed consent.\n* Participants who are not suitable to include in this study, evaluate by PI or Co-PI.'}, 'identificationModule': {'nctId': 'NCT04953767', 'briefTitle': 'The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Light Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Chang Gung Memorial Hospital'}, 'officialTitle': 'The Circadian Rhythm of ICU Patients With Acute Myocardial Infraction and the Effect of Dynamic Light Therapy : A Preliminary Study', 'orgStudyIdInfo': {'id': '201902108A3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blue light therapy', 'description': 'The participants receive blue light therapy for 1 hours, between 8am to 12pm in the morning.', 'interventionNames': ['Device: Blue light therapy']}, {'type': 'SHAM_COMPARATOR', 'label': 'White light', 'description': 'The participants receive white light for 1 hour, between 8am to 12pm in the morning.', 'interventionNames': ['Other: White light']}], 'interventions': [{'name': 'Blue light therapy', 'type': 'DEVICE', 'description': 'Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.', 'armGroupLabels': ['Blue light therapy']}, {'name': 'White light', 'type': 'OTHER', 'description': 'White light is used as sham control.', 'armGroupLabels': ['White light']}]}, 'contactsLocationsModule': {'locations': [{'zip': '333423', 'city': 'Taoyuan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Wei-Chih Chin', 'role': 'CONTACT', 'email': 'auaug0327@cgmh.org.tw', 'phone': '+886 3 3281200', 'phoneExt': '3836'}], 'facility': 'Wei-Chih Chin', 'geoPoint': {'lat': 24.99368, 'lon': 121.29696}}], 'centralContacts': [{'name': 'Wei-Chih Chin', 'role': 'CONTACT', 'email': 'auaug0327@cgmh.org.tw', 'phone': '+886 3 3281200', 'phoneExt': '3836'}], 'overallOfficials': [{'name': 'Wei-Chih Chin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chang Gung Medical Foundation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chang Gung Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}