Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT03685994
Status:
UNKNOWN
Last Update Posted:
2019-04-22
First Post:
2018-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Disorders After TIPS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-04-18', 'studyFirstSubmitDate': '2018-09-23', 'studyFirstSubmitQcDate': '2018-09-23', 'lastUpdatePostDateStruct': {'date': '2019-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of sleep disorders after TIPS', 'timeFrame': '1 year', 'description': 'The number of patients who suffer from sleep disorders after TIPS'}], 'secondaryOutcomes': [{'measure': 'Incidence of hepatic encephalopathy', 'timeFrame': '1 year', 'description': 'The number of patients who suffer from hepatic encephalopathy'}, {'measure': 'mortality', 'timeFrame': '1 year', 'description': 'The number of patients who died'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disorder']}, 'referencesModule': {'references': [{'pmid': '39465397', 'type': 'DERIVED', 'citation': 'Zhao M, Yan Y, Wang X, Liu B, Luo X. Sleep disturbance in patients with cirrhosis and transjugular intrahepatic portosystemic shunt. BMC Gastroenterol. 2024 Oct 28;24(1):381. doi: 10.1186/s12876-024-03470-x.'}]}, 'descriptionModule': {'briefSummary': 'The Purpose of a study to investigate the incidence of postoperative sleep disorders in patients undergoing transjugular intrahepatic portosystemic shunt ,and to analyze the relationship between risk factors and prognosis of sleep disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '100 patients who underwent TIPS in our hospital due to cirrhosis and portal hypertension.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. History of cirrhosis (clinical or by liver biopsy)\n2. Portal hypertension patients with defined indications for TIPS treatment\n3. Aged 18-75 years old\n4. Signed written informed consent\n\nExclusion Criteria:\n\n1. mental or nervous system diseases\n2. Patients with alcoholic cirrhosis who are still drinking\n3. Accompanied by serious heart, lung, brain and kidney diseases\n4. Preoperative diagnosis of sleep disorder\n5. Patients who are illiteracy\n6. The total score of the preoperative Hamilton anxiety scale was greater than or equal to 14 points, and the total score of 17 points of the Hamilton depression scale was greater than or equal to 18 points'}, 'identificationModule': {'nctId': 'NCT03685994', 'briefTitle': 'Sleep Disorders After TIPS', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'The Incidence of Sleep Disorders After Transjugular Intrahepatic Portosystemic Shunt', 'orgStudyIdInfo': {'id': 'SD-TIPS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the patients who will undergo TIPS'}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuefeng Luo, MD', 'role': 'CONTACT', 'phone': '862885422389'}], 'facility': 'West China Hospital', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'centralContacts': [{'name': 'Xufeng Luo, MD', 'role': 'CONTACT', 'email': 'luo_xuefeng@yeah.net', 'phone': '+86 13880098212'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'luo xuefeng', 'investigatorAffiliation': 'West China Hospital'}}}}