Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT05600595
Status:
UNKNOWN
Last Update Posted:
2022-10-31
First Post:
2022-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 450}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-10-27', 'studyFirstSubmitQcDate': '2022-10-27', 'lastUpdatePostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tympanogram', 'timeFrame': '6 weeks after operation', 'description': 'Acoustic immittance test'}], 'secondaryOutcomes': [{'measure': 'EDTQ-7 symptom score', 'timeFrame': '6 weeks after operation', 'description': "1. Pressure in the ears?\n2. Pain in the ears?\n3. A feeling that your ears are clogged or 'under water'?\n4. Ear symptoms when you have a cold or sinusitis?\n5. Crackling or popping sounds in the ears?\n6. Ringing in the ears?\n7. A feeling that your hearing is muffled"}, {'measure': 'Eustachian tube inflammation', 'timeFrame': '6 weeks after operation', 'description': 'Divided into 0=normal, 1=mild, 2=moderate, 3=severe'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eustachian Tube Dysfunction', 'Snoring in children'], 'conditions': ['Adenoidectomy', 'Tonsillectomy', 'Eustachian Tube Dysfunction']}, 'referencesModule': {'references': [{'pmid': '20564474', 'type': 'RESULT', 'citation': 'Ockermann T, Reineke U, Upile T, Ebmeyer J, Sudhoff HH. Balloon dilatation eustachian tuboplasty: a clinical study. Laryngoscope. 2010 Jul;120(7):1411-6. doi: 10.1002/lary.20950.'}, {'type': 'RESULT', 'citation': 'Bluestone CD,Bluestone MB. Eustachian tube：structure，function，role in otitis media. NY：BC Decker，2005'}, {'type': 'RESULT', 'citation': 'Mansour S，Magnan J，Haidar H，et al. Tympanic membrane retraction pocket. Springer International Publishing，2015：17'}, {'pmid': '29912819', 'type': 'RESULT', 'citation': "Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853."}, {'pmid': '28372527', 'type': 'RESULT', 'citation': 'Alper CM, Luntz M, Takahashi H, Ghadiali SN, Swarts JD, Teixeira MS, Csakanyi Z, Yehudai N, Kania R, Poe DS. Panel 2: Anatomy (Eustachian Tube, Middle Ear, and Mastoid-Anatomy, Physiology, Pathophysiology, and Pathogenesis). Otolaryngol Head Neck Surg. 2017 Apr;156(4_suppl):S22-S40. doi: 10.1177/0194599816647959.'}, {'pmid': '22500063', 'type': 'RESULT', 'citation': "D'Alatri L, Picciotti PM, Marchese MR, Fiorita A. Alternative treatment for otitis media with effusion: eustachian tube rehabilitation. Acta Otorhinolaryngol Ital. 2012 Feb;32(1):26-30."}, {'pmid': '25215457', 'type': 'RESULT', 'citation': 'Schroder S, Lehmann M, Sauzet O, Ebmeyer J, Sudhoff H. A novel diagnostic tool for chronic obstructive eustachian tube dysfunction-the eustachian tube score. Laryngoscope. 2015 Mar;125(3):703-8. doi: 10.1002/lary.24922. Epub 2014 Sep 12.'}, {'pmid': '32247766', 'type': 'RESULT', 'citation': 'Cayir S, Hizli O, Kayabasi S, Yildirim G. Eustachian tube dysfunction in sleep apnea patients and improvements afforded by continuous positive airway pressure therapy. Braz J Otorhinolaryngol. 2021 May-Jun;87(3):333-337. doi: 10.1016/j.bjorl.2020.02.003. Epub 2020 Mar 12.'}, {'pmid': '22344711', 'type': 'RESULT', 'citation': 'Robison JG, Wilson C, Otteson TD, Chakravorty SS, Mehta DK. Increased eustachian tube dysfunction in infants with obstructive sleep apnea. Laryngoscope. 2012 May;122(5):1170-7. doi: 10.1002/lary.22473. Epub 2012 Feb 16.'}, {'pmid': '33640801', 'type': 'RESULT', 'citation': 'Ahmed ST, Lin J, Moskowitz HS, Stupak HD. Can the negative pressures found in obstructive sleep apnea and Eustachian tube dysfunction be related? Am J Otolaryngol. 2021 Jul-Aug;42(4):102993. doi: 10.1016/j.amjoto.2021.102993. Epub 2021 Feb 18.'}]}, 'descriptionModule': {'briefSummary': "This study aims to evaluate and screen out the factors related to the improvement of eustachian tube function after adenoidectomy and/or tonsillectomy, so as to guide the treatment of children's eustachian tube function before and after operation, and provide the treatment direction and methods for diseases related to eustachian tube dysfunction for people with adenoid hypertrophy and/or tonsil hypertrophy complicated with ETD.", 'detailedDescription': "This study aims to analyze the changes of eustachian tube function in children with snoring and eustachian tube dysfunction before and after snoring surgery, and to evaluate and screen out the related factors related to the improvement of eustachian tube function after snoring surgery. The patients who were admitted to hospital and diagnosed as children's snoring complicated with diseases related to eustachian tube dysfunction and planned to undergo surgical treatment for children's snoring should be included, and relevant examinations should be improved, including preoperative nasopharyngoscope, otoscope, acoustic immittance and pure tone audiometry. After snoring operation, he returned to the hospital at 6, 12 and 24 weeks after operation for reexamination of nasopharyngoscope, otoscope, acoustic immittance, pure tone audiometry and TMM. The patients were assessed with ETDQ-7 score, ETS-7 score and VAS score by self-administered questionnaire. The effective risk-related factors were screened out by single factor and multi-factor Logistics regression analysis. To guide the treatment of children's eustachian tube function before and after operation, and to provide the treatment direction and methods for children's snoring diseases complicated with ETD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '3 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children with snoring complicated with eustachian tube dysfunction', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n① Age 3-14 years old.\n\n② Patients diagnosed as snoring or adenoid hypertrophy in children, tonsil hypertrophy and chronic tonsillitis who are to be treated by adenoidectomy or tonsillectomy or tonsillectomy;\n\n③ Conform to 1. Symptoms: snoring during sleep, breathing with mouth open, some with apnea, restless sleep, and a few children with hearing loss. 2. Fiberoptic nasopharyngoscopy showed adenoids and/or tonsil hypertrophy. 3. No family history of deafness, no history of ototoxic drugs. 4. No external ear and maxillofacial deformity. 5. The tympanic pressure curve is "C" or "B". 6. No suppurative medium.\n\nAuricular inflammation and tympanic membrane perforation; Adhesive otitis media, cholesteatoma of middle ear.\n\n④ Patients\' families cooperated well.\n\n⑤ The patient\'s guardian volunteered to participate in this study and signed the informed consent form.\n\nExclusion Criteria:\n\n* Middle ear catheterization or puncture was performed at the same time;\n\n * Eustachian atresia or cleft lip and palate; There are craniofacial abnormalities or neuromuscular diseases;\n\n * Benign and malignant tumors of nose or nasopharynx;\n\n * Other middle ear diseases (suppurative otitis media, tympanic membrane perforation; Adhesive otitis media, middle ear cholesteatoma, etc.); ⑤ Those who can\'t cooperate; ⑥ Previous tonsil and adenoid surgery; ⑦ Upper respiratory tract infection in recent two weeks; ⑧ Any other circumstances that researchers think should be excluded from this study;'}, 'identificationModule': {'nctId': 'NCT05600595', 'briefTitle': 'The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring Operation in Children', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'The Evaluation of Eustachian Tube Function and Its Influencing Factors After Snoring in Children', 'orgStudyIdInfo': {'id': 'SYSKY-2022-350-01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Operation for snoring in children', 'type': 'PROCEDURE', 'description': 'Tonsillectomy and/or adenoidectomy'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hao Xiong, doctorate', 'role': 'CONTACT', 'email': 'xiongh7@mail.sysu.edu.cn', 'phone': '13725130384'}], 'facility': 'Sun Yat-sen Memorial Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Hao Xiong', 'role': 'CONTACT', 'email': 'xiongh7@mail.sysu.edu.cn', 'phone': '13725130384'}, {'name': 'Wenting Deng', 'role': 'CONTACT', 'email': 'dengwt23@mail.sysu.edu.cn', 'phone': '15017556968'}], 'overallOfficials': [{'name': 'Hao Xiong', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangzhou Women and Children's Medical Center", 'class': 'OTHER'}, {'name': "Xiaolan People's Hospital of Zhongshan City", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}