Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT06819202
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Hyperbaric Oxygen Therapy(HBOT) on Patients With Sudden Sensorineural Hearing Loss(SSNHL) and Coagulation Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003639', 'term': 'Hearing Loss, Sudden'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1309}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2025-01-25', 'studyFirstSubmitQcDate': '2025-02-04', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hearing recovery rate', 'timeFrame': 'From onset to 3 months after treatment', 'description': 'The rate of hearing recovery in patients with all levels of hearing loss at completion of treatment and at 3 months after termination of treatment was assessed according to the WHO Hearing Loss Rating Criteria 2021 to determine the success of treatment.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sudden Sensorineural Hearing Loss (SSNHL)', 'Hyperbaric Oxygen Therapy']}, 'descriptionModule': {'briefSummary': 'The objective of this observational study was to understand the effect of HBO on patients with SSNHL and its association with coagulation function and prognosis.\n\nThe main question it aims to answer is whether HBO therapy can improve outcomes and coagulation function in patients with SSNHL.\n\nThe prognosis of SSNHL patients receiving HBO and SSNHL patients not receiving HBO were compared'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "From January 2022 to September 2024, in Putuo Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Otolaryngology Hospital Affiliated to Fudan University, Xinhua Hospital affiliated to Shanghai Jiao Tong University or Ninth People's Hospital Affiliated to Shanghai Jiao Tong University, treating patients with sudden sensorineural deafness.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the diagnostic criteria for sudden deafness in the American Academy of Otolaryngology Head and Neck Surgery 2019 Clinical Practice Guidelines for Sudden Deafness;\n* Aged 18-75 years old;\n* Patients with unilateral sudden deafness for the first time, and the onset time is less than 2 weeks.\n\nExclusion Criteria:\n\n* Patients with other ear diseases, such as auditory trauma, barotrauma, retrocochlear disease, bilateral hearing loss, history of chronic otitis media in the same ear, and history of surgery in the same ear;\n* Patients with serious primary diseases such as heart, liver, kidney dysfunction and hematopoietic system diseases;\n* Pregnant and nursing patients;\n* Accompanied by serious mental illness;\n* Patients with incomplete clinical data.'}, 'identificationModule': {'nctId': 'NCT06819202', 'briefTitle': 'Effect of Hyperbaric Oxygen Therapy(HBOT) on Patients With Sudden Sensorineural Hearing Loss(SSNHL) and Coagulation Function', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai University of Traditional Chinese Medicine'}, 'officialTitle': 'Effect of Hyperbaric Oxygen Therapy on Patients With Sudden Sensorineural Hearing Loss and Coagulation Function', 'orgStudyIdInfo': {'id': 'PTEC-A-2025-1(S)-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Hyperbaric oxygen treatment', 'type': 'OTHER', 'description': 'HBO therapy is the process of inhaling 100% pure oxygen in an environment above one atmosphere (pressure range: 2.0-3.0 absolute atmospheres) to treat a disease.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200333', 'city': 'Shanghai', 'state': 'Putuo', 'country': 'China', 'contacts': [{'name': 'Sun YT Sun, PhD student', 'role': 'CONTACT', 'email': 'syt_354@163.com', 'phone': '19821758594'}], 'facility': 'Shanghai University of Traditional Chinese Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Sun Yuting', 'role': 'CONTACT', 'email': 'syt_354@163.com', 'phone': '+89 198 2175 8594'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yuting', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PhD student', 'investigatorFullName': 'Sun Yuting', 'investigatorAffiliation': 'Shanghai University of Traditional Chinese Medicine'}}}}