Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04367558
Status:
UNKNOWN
Last Update Posted:
2020-05-27
First Post:
2020-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-26', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-04-27', 'lastUpdatePostDateStruct': {'date': '2020-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'More than 50% improvement in Apnea-Hypopnea index (AHI)', 'timeFrame': '6 months following the procedure', 'description': 'Measuring the AHI score using sleep laboratory'}, {'measure': 'More than 50% improvement in Apnea-Hypopnea index (AHI)', 'timeFrame': '12 months following the procedure', 'description': 'Measuring the AHI score using sleep laboratory'}, {'measure': 'Reduction of AHI to below 20', 'timeFrame': '6 months following the procedure', 'description': 'Measuring the AHI score using sleep laboratory'}, {'measure': 'Reduction of AHI to below 20', 'timeFrame': '12 months following the procedure', 'description': 'Measuring the AHI score using sleep laboratory'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Apnea Syndromes, Obstructive']}, 'descriptionModule': {'briefSummary': 'Obstructive Sleep apnea carries a variety of complications and implications. While the disease could be treated using continuous positive airway pressure (CPAP) and lifestyle changes, many patients find it difficult to adjust to the mask, and turn to surgical options. The conventional surgical options to date ranges from radical (UPPP) to individualized, with or without Drug-induced sleep endoscopy (DISE). Previous studies showed that dise directed surgery can be useful for specific conditions. No trials were found to test in-office encompassing minimal invasive surgical treatment (RF palatoplasty , RF tonsillotomy, RF turbinectomy, and RF base-of-tongue reduction) as a viable alternative..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from OSA, defined as AHI \\> 5\n\nExclusion Criteria:\n\n* Patients who can use CPAP.\n* Patients suffering from confounding factors with higher risk (Coagulation problems, Heart conditions, chronic obstructive pulmonary disease (COPD), or other dangerous conditions as decided by the surgeon)\n* Patients suffering from other problems aggravating the OSA (Respiratory, Neurologic conditions)'}, 'identificationModule': {'nctId': 'NCT04367558', 'briefTitle': 'Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Possible Efficacy of Minimal Surgical Treatment for Obstructive Sleep Apnea (OSA)', 'orgStudyIdInfo': {'id': '0010-20-HYMC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': 'Patient suffering from OSA, and found to suffer from obstruction of one or more of the following areas - Lower turbines, Soft Palate, Tonsils, Base-of-tongue.', 'interventionNames': ['Procedure: Minimally invasive, in-office, RF reduction of the affected area']}], 'interventions': [{'name': 'Minimally invasive, in-office, RF reduction of the affected area', 'type': 'PROCEDURE', 'description': 'Usage of RF needle to treat one or more of the affected areas', 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Itzhak Braverman, MD', 'role': 'CONTACT', 'email': 'braverman@hy.health.gov.il', 'phone': '972-4-630-4549'}, {'name': 'Itzhak Braverman, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hillel Yaffe MC,', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Itzhak Braverman, MD', 'role': 'CONTACT', 'email': 'braverman@hy.health.gov.il', 'phone': '972-4-7744664'}, {'name': 'Isaac Shochat, MD', 'role': 'CONTACT', 'email': 'isaacs@hy.health.gov.il', 'phone': '972-4-7744664'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}