Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2025-12-25 @ 6:46 PM
Study NCT ID:
NCT00393159
Status:
UNKNOWN
Last Update Posted:
2006-10-26
First Post:
2006-10-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}, {'id': 'D006314', 'term': 'Hearing Loss, Conductive'}, {'id': 'D010031', 'term': 'Otitis'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-10', 'lastUpdateSubmitDate': '2006-10-24', 'studyFirstSubmitDate': '2006-10-24', 'studyFirstSubmitQcDate': '2006-10-24', 'lastUpdatePostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Audiometry and tympanometry test results at at 7 weeks and 3 months from beginning of use of the ear popper.'}, {'measure': 'Otoscopic findings at at 7 weeks and 3 months from beginning of use of the ear popper.'}], 'secondaryOutcomes': [{'measure': 'Hearing improvement at 7 weeks and 3 months from the beginning of the trial.'}, {'measure': 'Rate of referrals for tympanostomy tube insertion at 3 months'}]}, 'conditionsModule': {'keywords': ['Effusion', 'Otitis', 'Media', 'Ear', 'Popper', 'Children'], 'conditions': ['Otitis Media', 'Conductive Hearing Loss']}, 'descriptionModule': {'briefSummary': 'This study is designed to check the effect of the use of the ear popper device on serous otitis media in children and on the conductive hearing loss accompanying the otitis. It is intended that 30 children aged 3-18 years will participate in the study. The inclusion criteria are : clinical serous otitis media for a duration of more then 3 months, a conductive hearing loss of at least 15 decibels air bone gap and tympanometry type B or C. The children will use the ear popper for 7 weeks. They will undergo otologic examination, audiometry and tympanometry at the beginning ao the trial, at 7 weeks and at 3 months from the beginning of the trial. The otologic findings and the audiometry and tympanometry results before and after the trial will be compared. We will try to determine whether the use of the ear popper in the test group will improve the conductive hearing loss and prevent the need for tympanostomy tube insertion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Serous Otitis Media for More Then 3 months\n* Conductive Hearing Loss of More Then 15 decibels.\n* Tympanometry type B or C.\n\nExclusion Criteria:\n\n* No History of Tympanostomy Tube Insertion or Adenoidectomy\n* No Cranio or Facial Malformations\n* No Acute Upper Respiratory Tract Infection or Acute Otitis Media'}, 'identificationModule': {'nctId': 'NCT00393159', 'briefTitle': 'The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children', 'orgStudyIdInfo': {'id': 'TASMC06YO3567CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ear Popper', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Yael Oestreicher, MD', 'role': 'CONTACT', 'email': 'dkyo@barak-online.net.il', 'phone': '972-3-6974517'}, {'name': 'Yael Oestreicher, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "ENT Unit, Dana Children's Hospital, Tel-Aviv Medical Center", 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Yael Oestreicher, MD', 'role': 'CONTACT', 'email': 'dkyo@barak-online.net.il', 'phone': '972-3-6974517'}, {'name': 'Ari DeRowe, MD', 'role': 'CONTACT', 'phone': '972-3-6974517'}], 'overallOfficials': [{'name': 'Yael Oestreicher, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tel Aviv Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}}}}