Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-01-03 @ 5:23 AM
Study NCT ID:
NCT06283095
Status:
RECRUITING
Last Update Posted:
2024-02-28
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation the outcome of expansion palatoplasty in management of OSAS.', 'timeFrame': 'Six months', 'description': 'Polysomngrophy'}], 'secondaryOutcomes': [{'measure': 'Expansion palatoplasty in Obstructive sleep apnea patients', 'timeFrame': 'Six months', 'description': 'Drug induced sleep endoscopy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obstructive Sleep Apnea of Adult']}, 'descriptionModule': {'briefSummary': 'The study will be conducted to evaluate the outcome of expansion palatoplasty in management of OSAS.', 'detailedDescription': 'Expansion palatopladty will be conducted on patients with obstructive sleep apnea patients to evaluate the outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients.\n* Body mass index \\< 30 kg/m2 (weight /height in m2)\n* Mild to moderate OSAS\n* Sagittal collapse of the lateral pharyngeal walls proved by Drug induced sleep endoscopy (DISE).\n\nExclusion Criteria:\n\n* • Refusing enrollment into the study.\n\n * Pregnant women.\n * Refusing the surgery\n * Contraindication to anaesthesia\n * Patients with multilevel of obstruction.\n * Serious psychiatric, neurological and cardiopulmonary (COPD or corpulmonale) diseases.\n * Uncorrected hypothyroidism.\n * Severe OSAS.\n * Craniofacial anamolies.\n * Central\\& mixed apnea\n * Morbid obesity.'}, 'identificationModule': {'nctId': 'NCT06283095', 'briefTitle': 'Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Management of Obstructive Sleep Apnea Syndrome by Expansion Palatoplasty', 'orgStudyIdInfo': {'id': 'OSA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'description': 'we will do expansion palatoplasty', 'interventionNames': ['Procedure: expansion palatoplasty']}], 'interventions': [{'name': 'expansion palatoplasty', 'type': 'PROCEDURE', 'description': 'surgical procedure', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Enas T Zarief, physician', 'role': 'CONTACT', 'email': 'enas.tharwat23@gmail.com', 'phone': '01226270800'}], 'facility': 'ASSUIT', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Enas T Zarief', 'role': 'CONTACT', 'email': 'enas.tharwat23@gmail.com', 'phone': '01226270800'}, {'name': 'Mohamed O Gad', 'role': 'CONTACT', 'email': 'mohamedomar18@yahoo.com', 'phone': '01022350318'}], 'overallOfficials': [{'name': 'Enas T Zarief', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit U'}]}, 'ipdSharingStatementModule': {'url': 'http://enas.tharwat23@gmail.com', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Three years', 'ipdSharing': 'YES', 'description': 'Managment of OSAS', 'accessCriteria': 'OSAS'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ET Zarief', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'ET Zarief', 'investigatorAffiliation': 'Assiut University'}}}}