Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-01-04 @ 6:47 AM
Study NCT ID:
NCT04192656
Status:
RECRUITING
Last Update Posted:
2019-12-10
First Post:
2019-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of PAP on ISSHL Comorbided With OSA
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003639', 'term': 'Hearing Loss, Sudden'}, {'id': 'D020181', 'term': 'Sleep Apnea, Obstructive'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'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'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'C526713', 'term': 'ginaton'}, {'id': 'C063170', 'term': 'Ginkgo biloba extract'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2029-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-09', 'studyFirstSubmitDate': '2019-12-09', 'studyFirstSubmitQcDate': '2019-12-09', 'lastUpdatePostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hearing threshold', 'timeFrame': '3 months after onset of ISSHL', 'description': 'the recovery of hearing threshold which will be measured by pure tone audiometry'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sudden Hearing Loss', 'Obstructive Sleep Apnea']}, 'referencesModule': {'references': [{'pmid': '23710145', 'type': 'BACKGROUND', 'citation': 'Hizli O, Ozcan M, Unal A. Evaluation of comorbidities in patients with OSAS and simple snoring. ScientificWorldJournal. 2013 Apr 18;2013:709292. doi: 10.1155/2013/709292. Print 2013.'}, {'pmid': '25388224', 'type': 'BACKGROUND', 'citation': 'Kayabasi S, Iriz A, Cayonu M, Cengiz B, Acar A, Boynuegri S, Mujdeci B, Eryilmaz A. Vestibular functions were found to be impaired in patients with moderate-to-severe obstructive sleep apnea. Laryngoscope. 2015 May;125(5):1244-8. doi: 10.1002/lary.25021. Epub 2014 Nov 12.'}, {'pmid': '21479758', 'type': 'BACKGROUND', 'citation': 'Casale M, Vesperini E, Potena M, Pappacena M, Bressi F, Baptista PJ, Salvinelli F. Is obstructive sleep apnea syndrome a risk factor for auditory pathway? Sleep Breath. 2012 Jun;16(2):413-7. doi: 10.1007/s11325-011-0517-x. Epub 2011 Apr 9.'}, {'pmid': '30134647', 'type': 'BACKGROUND', 'citation': 'Fu Q, Wang T, Liang Y, Lin Y, Zhao X, Wan J, Fan S. Auditory Deficits in Patients With Mild and Moderate Obstructive Sleep Apnea Syndrome: A Speech Syllable Evoked Auditory Brainstem Response Study. Clin Exp Otorhinolaryngol. 2019 Feb;12(1):58-65. doi: 10.21053/ceo.2018.00017. Epub 2018 Aug 24.'}, {'pmid': '22249630', 'type': 'BACKGROUND', 'citation': 'Sheu JJ, Wu CS, Lin HC. Association between obstructive sleep apnea and sudden sensorineural hearing loss: a population-based case-control study. Arch Otolaryngol Head Neck Surg. 2012 Jan;138(1):55-9. doi: 10.1001/archoto.2011.227.'}]}, 'descriptionModule': {'briefSummary': 'This clinical randomized controlled study is to explore the effect of positive airway pressure(PAP) on patients in Beijing Tsinghua Changgung Hospital diagnosed with both idiopathic sudden sensorineural hearing loss comorbided(ISSHL) and obstructive sleep apnea(OSA) between Dec. 2019 to Dec. 2029.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged \\>= 18 and \\<= 70,\n2. diagnosed with OSA by full-night in-lab or home-stay PSG according to AASM 2012 criteria, and AHI \\> 15/h,\n3. diagnosed with ISSHL by AAO-HNS 2019 criteria,\n4. ISSHL onset within 1 week.\n\nExclusion Criteria:\n\n1. sudden hearing loss with certain causes,\n2. with severe comorbid diseases,\n3. pregnant or breast-feeding women,\n4. AHI \\<= 15/h,\n5. hearing threshold recovered \\> 50% when included,\n6. previously regularly treated with PAP.'}, 'identificationModule': {'nctId': 'NCT04192656', 'briefTitle': 'The Effect of PAP on ISSHL Comorbided With OSA', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'The Effect of Positive Airway Pressure on Idiopathic Sudden Sensorineural Hearing Loss Comorbided With Obstructive Sleep Apnea: A Clinical Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'BTCHENT201901'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PAP plus medication', 'description': 'patients treated by both PAP and medication', 'interventionNames': ['Device: non-invasive positive airway pressure', 'Drug: Methylprednisolone Hemisuccinate', 'Drug: Ginaton']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'medication', 'description': 'patients treated by medication only', 'interventionNames': ['Drug: Methylprednisolone Hemisuccinate', 'Drug: Ginaton']}], 'interventions': [{'name': 'non-invasive positive airway pressure', 'type': 'DEVICE', 'description': 'non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea', 'armGroupLabels': ['PAP plus medication']}, {'name': 'Methylprednisolone Hemisuccinate', 'type': 'DRUG', 'otherNames': ['Methylprednisolone, MP'], 'description': 'Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss', 'armGroupLabels': ['PAP plus medication', 'medication']}, {'name': 'Ginaton', 'type': 'DRUG', 'otherNames': ['Ginkgo biloba extract,GBE'], 'description': 'ginnaton is ginkgo biloba extract', 'armGroupLabels': ['PAP plus medication', 'medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100028', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Cao', 'role': 'CONTACT', 'email': 'caoxin19860201@163.com', 'phone': '86-15810519277'}, {'name': 'Mu He', 'role': 'CONTACT', 'email': 'muhe2009@qq.com', 'phone': '86-15210588954'}], 'facility': 'Beijing Tsinhgua Changgung Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jingying Ye, MD', 'role': 'CONTACT', 'email': 'yejingying@163.vip.com', 'phone': '+86-13701396970'}, {'name': 'Haijin Yi, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Juanjuan Gao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}, {'name': 'jingying Ye, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}, {'name': 'Haijin Yi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}, {'name': 'Mu He, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}, {'name': 'Xin Cao, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}, {'name': 'Xingxing Lu, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}, {'name': 'Sichao Liang, MA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tsinghua Changung Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the dept. of Otolaryngology, Head and Neck Surgery, and Director of the Center of Sleep Medicine', 'investigatorFullName': 'Ye Jingying', 'investigatorAffiliation': 'Beijing Tsinghua Chang Gung Hospital'}}}}