Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-02 @ 3:43 PM
Study NCT ID:
NCT03659760
Status:
COMPLETED
Last Update Posted:
2025-02-11
First Post:
2018-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
: Association of Melatonin Levels and Light and Noise Isolation in ICU
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003389', 'term': 'Cranial Nerve Diseases'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'prospective randomize'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-10', 'studyFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-09-05', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Melatonin level', 'timeFrame': 'At preoperative 07:00 am', 'description': 'Melatonin will be measured urine 6-sulphatoxymelatonin'}, {'measure': 'Melatonin level', 'timeFrame': '07:00 am postoprative day 1', 'description': 'Melatonin will be measured urine 6-sulphatoxymelatonin'}, {'measure': 'Melatonin level', 'timeFrame': '07:00 am postoprative day 3', 'description': 'Melatonin will be measured urine 6-sulphatoxymelatonin'}], 'secondaryOutcomes': [{'measure': 'IL-1,IL-6,CRP', 'timeFrame': ": at 7 o'clock in the morning preoperative day, 7 in the morning on the first postoperative day and 7 in the morning on the third postoperative day hour", 'description': 'serum'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Melatonin', 'Interleukin', 'Transcranial', 'Surgery', 'Intensive care'], 'conditions': ['Cranial Nerve Diseases']}, 'referencesModule': {'references': [{'pmid': '29347988', 'type': 'BACKGROUND', 'citation': 'Grima NA, Rajaratnam SMW, Mansfield D, Sletten TL, Spitz G, Ponsford JL. Efficacy of melatonin for sleep disturbance following traumatic brain injury: a randomised controlled trial. BMC Med. 2018 Jan 19;16(1):8. doi: 10.1186/s12916-017-0995-1.'}, {'pmid': '28895895', 'type': 'BACKGROUND', 'citation': 'Yasar NF, Badak B, Canik A, Bas SS, Uslu S, Oner S, Ates E. Effects of Sleep Quality on Melatonin Levels and Inflammatory Response after Major Abdominal Surgery in an Intensive Care Unit. Molecules. 2017 Sep 12;22(9):1537. doi: 10.3390/molecules22091537.'}, {'pmid': '29786658', 'type': 'BACKGROUND', 'citation': 'Osier N, McGreevy E, Pham L, Puccio A, Ren D, Conley YP, Alexander S, Dixon CE. Melatonin as a Therapy for Traumatic Brain Injury: A Review of Published Evidence. Int J Mol Sci. 2018 May 22;19(5):1539. doi: 10.3390/ijms19051539.'}, {'pmid': '23825812', 'type': 'BACKGROUND', 'citation': 'Kurdi MS, Patel T. The role of melatonin in anaesthesia and critical care. Indian J Anaesth. 2013 Mar;57(2):137-44. doi: 10.4103/0019-5049.111837.'}]}, 'descriptionModule': {'briefSummary': 'Melatonin is secreted from the epiphyseal gland with a circadian rhythm and is known to be anti-inflammatory.\n\nIn this study, it is planned to investigate the effect of sleep disruptions on melatonin levels and inflammation parameters in intensive care patients underwent transcranial surgery', 'detailedDescription': 'Patients with Glasgow coma scale (GKS) \\>14, American Society of Anesthesiologist (ASA) I-III, intensive care patients underwent transcranial surgery will be included\n\nPatients will be randomly allocated by a computer generated random numbers list into two groups.\n\nPatients with sleep disruptions (Group I) (exposed to ambient light and noise) and Patients without sleep disruptions (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)\n\nMelatonin levels will be measured by urine 6-sulfatoxymelatonin (a-MT6) levels, which is a product of melatonin degradation at 07:00 am preoperative and postoperative day 1 and day 3.\n\nPlasma Interleukin-1 (IL-1), Interleukin- 6 (IL-6),C-reactive protein (CRP) levels will be measured at 07:00 am preoperative and postoperative day 1and day 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* ASA 1-3\n* Glasgow Coma Scale(GCS) \\>14\n\nExclusion Criteria:\n\n* Glasgow Coma Scale(GCS) \\<14\n* Patients who do not understand the questions, not awake\n* Patient who treated with hormones\n* Patient with infection or inflammatory disease'}, 'identificationModule': {'nctId': 'NCT03659760', 'briefTitle': ': Association of Melatonin Levels and Light and Noise Isolation in ICU', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Diskapi Yildirim Beyazit Education and Research Hospital'}, 'officialTitle': 'Does Light and Noise Isolation Change the Melatonin Levels and Inflammatory Response After Cranial Surgery in an Intensive Care Unit', 'orgStudyIdInfo': {'id': 'EmineMelatonin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Isolated', 'description': 'Group Isolated (Group II) (eyes closed with patch and ear plugged; between 24:00-06:00)', 'interventionNames': ['Other: Group Isolated']}, {'type': 'NO_INTERVENTION', 'label': 'Group Disrupted', 'description': 'Group Disrupted (Group I) (exposed to ambient light and noise)'}], 'interventions': [{'name': 'Group Isolated', 'type': 'OTHER', 'description': 'Eyes closed with patch and ears plugged between 24:00-06:00', 'armGroupLabels': ['Group Isolated']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Universty of Health Sciences, Dıskapı Yıldırım Beyazıt Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Emine Arık', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Yildirim Beyazit Education and Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist in Anesthesia', 'investigatorFullName': 'Emine Arik', 'investigatorAffiliation': 'Diskapi Yildirim Beyazit Education and Research Hospital'}}}}