Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT04928404
Status:
UNKNOWN
Last Update Posted:
2021-06-22
First Post:
2021-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-01-25', 'releaseDate': '2023-05-03'}], 'estimatedResultsFirstSubmitDate': '2023-05-03'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'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': 13}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-16', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2021-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'changes in obstructive sleep apnea', 'timeFrame': '3 months after intervention', 'description': 'using polysomnography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['tongue base', 'tongue base suspension', 'barbed suture'], 'conditions': ['Obstructive Sleep Apnea']}, 'descriptionModule': {'briefSummary': 'Obstructive sleep apnea syndrome (OSAS) is a common clinical condition in which the throat narrows or collapses repeatedly during sleep, causing obstructive sleep apnea events.\n\nOne of the most common sites for collapse during sleep is hypo-pharyngeal space. It was founded in 50% of OSA patients those have moderate and severe apnea.\n\nDeRowe et al invented the Tongue base suspension operation in 1998 for sleep disordered breathing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI of patients less than 35 kg/m2.\n* Patients who have symptoms and signs of OSA.\n* Moderate to severe OSAHS confirmed by formal polysomnography (defined as an AHI ≥15).\n* Friedman tongue position III or IV.\n* Documented failure/refusal of attempts of conservative treatment measures (not limited to continuous positive airway pressure).\n* The presence of retrolingual collapse confirmed preoperatively with flexible fiberoptic endoscope during Muller maneuver.\n* Patients have macroglossia as defined by posterior airspace (PAS) of ≤10mm.\n\nExclusion Criteria:\n\n* Failure to attend postoperative follow-up polysomnography within 6 months of surgery.\n* Previous surgery to the base of the tongue or other surgical treatment of OSAHS.\n* A history of malignancy or infection of the head and neck region, laryngeal trauma, or other previous oropharyngeal/laryngeal surgery.\n* Patients have retrognanthia sella-nasion-supra mentale (SNB) ≥76º.\n* Huge lymphoid tissue of the tongue and/or lingual tonsil.'}, 'identificationModule': {'nctId': 'NCT04928404', 'briefTitle': 'Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Barbed Suspension of the Tongue Base for Treatment of Obstructive Sleep Apnea Patients', 'orgStudyIdInfo': {'id': 'Soh-med-21-06-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'obstructive sleep apnea patients', 'interventionNames': ['Procedure: tongue base suspension using barbed suture']}], 'interventions': [{'name': 'tongue base suspension using barbed suture', 'type': 'PROCEDURE', 'description': 'all patients will undergo multi-level surgeries .Therefor, Anterolateral advancement pharyngeoplasty (ALA) or Barbed Reposition Pharyngoplasty (BRP) will be applied to improve retro-palatal obstruction and tongue base suspension using barbed suture for retro-lingual obstruction.', 'armGroupLabels': ['obstructive sleep apnea patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'hassan noamen, professor', 'role': 'CONTACT', 'email': 'portal@med.sohag.edu.eg'}], 'facility': 'Sohag university', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohameed Moussa, specialist', 'role': 'CONTACT', 'email': 'mabdelmatien_post@med.sohag.edu.eg', 'phone': '01011178222'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Otorhinolaryngology specialist', 'investigatorFullName': 'Mohammed Abd Elmateen Moussa', 'investigatorAffiliation': 'Sohag University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-05-03', 'type': 'RELEASE'}, {'date': '2024-01-25', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mohammed Abd Elmateen Moussa, Otorhinolaryngology specialist, Sohag University'}}}}