Ignite Creation Date:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT03715569
Status:
UNKNOWN
Last Update Posted:
2018-10-23
First Post:
2018-06-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CNS Infections Effect on the Inner Ear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002494', 'term': 'Central Nervous System Infections'}, {'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}, {'id': 'D007759', 'term': 'Labyrinth Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'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': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014724', 'term': 'Vestibular Function Tests'}, {'id': 'D000074062', 'term': 'Environmental Biomarkers'}, {'id': 'D001299', 'term': 'Audiometry'}], 'ancestors': [{'id': 'D003939', 'term': 'Diagnostic Techniques, Otological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D015415', 'term': 'Biomarkers'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004784', 'term': 'Environmental Monitoring'}, {'id': 'D004781', 'term': 'Environmental Exposure'}, {'id': 'D004787', 'term': 'Environmental Pollution'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D006320', 'term': 'Hearing Tests'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Cerebral fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-18', 'studyFirstSubmitDate': '2018-06-01', 'studyFirstSubmitQcDate': '2018-10-18', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cochlear damage', 'timeFrame': 'Day1-90', 'description': 'Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.'}], 'secondaryOutcomes': [{'measure': 'Vestibular function loss', 'timeFrame': 'Day 1-90', 'description': 'Assess the frequency of vestibular function loss by using VHit and Caloic tests.'}, {'measure': 'Identifying biochemical markers in CSF during a CNS infection', 'timeFrame': 'Day 1-90', 'description': 'Identify biomarkers, such as Cochlin, in CSF and assess their ability to predict sequelae.'}, {'measure': 'Cognitive impairment', 'timeFrame': 'Day 90', 'description': 'Assess the frequency and serverity of cognitive impariment by using MOCA scores.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['CNS Infection', 'Inner Ear Hearing Loss', 'Vestibular Abnormality', 'Inner Ear Inflammation', 'Hearing Loss, Sensorineural']}, 'descriptionModule': {'briefSummary': 'Study on patients with CNS infections.', 'detailedDescription': 'Aims and objectives:\n\nThe present proposal aims to improve the outcome from central nervous system infections (CNS) by improving the understanding of when and why patients develop hearing loss and other neurological sequelae. The investigators will elucidate the temporal development and restitution of a sensorineural hearing loss and will clarify if any therapeutic window exists, where sequelae can be limited.\n\nAlso the investigators will investigate if communication between cochlea and cerebrospinal fluid is a window to the intracranial pressure.\n\nBackground:\n\nCNS infections remain diseases with high mortality and morbidity. Among survivors from bacterial meningitis, 30 % suffer hearing loss or deafness arising from injury to the inner ear - the cochlea. From previous work it is known that brain inflammation, brain edema and subsequent pressure changes can be transduced to the inner ear due to communication between the cochlea and cerebrospinal fluid (CSF).\n\nThe viability of cochlear hair cells can evaluated by non-invasive measurement of otoacoustic (OAE) emissions which are low-intensity sounds from the cochlea (OAE).\n\nMethods and materials:\n\nThe investigators will perform repeated measurements of OAE and Wide Band tympanometry (WBT) in all patients admitted with suspicion of a CNS infection. OAE and WBT will be compared to intracranial pressure (ICP) measured during lumbar puncture as well as clinical-, biochemical- and imaging data. An age-matched control group will be included. At discharge and at follow-up patients will receive a neurological, vestibulare examination, cognitive test and a regular hearing test.\n\nExpected outcome and perspectives:\n\nFrom repeated measures during a course of disease, the investigators will elucidate the development of a hearing loss and clarify if any therapeutic window exists, where sequelae can be limited. This is also an opportunity to assess OAE as a non-invasive measure of intracranial pressure which is believed to be among the clinical complications responsible for a poor outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients admitted to the hospital with a CNS infection.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a CNS infection admitted to the hospital.\n\nExclusion Criteria:\n\n* Patients with known hearing loss'}, 'identificationModule': {'nctId': 'NCT03715569', 'briefTitle': 'CNS Infections Effect on the Inner Ear', 'organization': {'class': 'OTHER', 'fullName': 'Nordsjaellands Hospital'}, 'officialTitle': 'CNS Infections Effect on the Inner Ear', 'orgStudyIdInfo': {'id': 'PM52008'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort with CNS infections', 'description': 'Otoacoustic emissions (OAE), Wide Band Tympanometry (WBT), Vestibular function tests. Audiometry. MOCA, eGOS are cognitive tests.\n\nBiomarker is a protein found in the inner ear examined in the cerebral fluid.', 'interventionNames': ['Diagnostic Test: Vestibular function', 'Diagnostic Test: OAE/WBT', 'Diagnostic Test: Biomarker', 'Diagnostic Test: MOCA, eGOS', 'Diagnostic Test: Audiometry']}, {'label': 'OAE/WBT control: Healthy individuals', 'description': 'Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.', 'interventionNames': ['Diagnostic Test: OAE/WBT']}, {'label': 'OAE/WBT control: Systemic infection', 'description': 'Otoacoustic emission during admission', 'interventionNames': ['Diagnostic Test: OAE/WBT']}, {'label': 'OAE/WBT control: ICP changes', 'description': 'Otoacoustic emission on patients without an CNS infection before and after elective lumbare puncture with measurement of intracranial pressure (ICP).', 'interventionNames': ['Diagnostic Test: OAE/WBT']}, {'label': 'Biomarker control', 'description': 'Inner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation.', 'interventionNames': ['Diagnostic Test: Biomarker']}], 'interventions': [{'name': 'Vestibular function', 'type': 'DIAGNOSTIC_TEST', 'description': 'Vhit, Caloric test', 'armGroupLabels': ['Cohort with CNS infections']}, {'name': 'OAE/WBT', 'type': 'DIAGNOSTIC_TEST', 'description': 'Oto acoustic emissions Wide Band Tympanometry', 'armGroupLabels': ['Cohort with CNS infections', 'OAE/WBT control: Healthy individuals', 'OAE/WBT control: ICP changes', 'OAE/WBT control: Systemic infection']}, {'name': 'Biomarker', 'type': 'DIAGNOSTIC_TEST', 'description': 'Biomarker examination', 'armGroupLabels': ['Biomarker control', 'Cohort with CNS infections']}, {'name': 'MOCA, eGOS', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cognitive tests', 'armGroupLabels': ['Cohort with CNS infections']}, {'name': 'Audiometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Hearing test', 'armGroupLabels': ['Cohort with CNS infections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3400', 'city': 'Hillerød', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Christian Brandt, MD', 'role': 'CONTACT', 'email': 'Christian.thomas.brandt.01@reigonh.dk'}], 'facility': 'Hillerød hospital', 'geoPoint': {'lat': 55.92791, 'lon': 12.30081}}], 'centralContacts': [{'name': 'Elisa Skovgaard Jensen, MD', 'role': 'CONTACT', 'email': 'elisa.skovgaard.jensen@regionh.dk', 'phone': '+4530300969'}, {'name': 'Christian Brandt, MD', 'role': 'CONTACT', 'email': 'christian.thomas.brandt.01@regionh.dk'}], 'overallOfficials': [{'name': 'Christian Brandt, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of infectious diseases'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nordsjaellands Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hvidovre University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Elisa Skovgaard Jensen', 'investigatorAffiliation': 'Nordsjaellands Hospital'}}}}