Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
700 participants
OBSERVATIONAL
2017-12-01
2020-12-01
Brief Summary
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Detailed Description
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The 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.
Also the investigators will investigate if communication between cochlea and cerebrospinal fluid is a window to the intracranial pressure.
Background:
CNS 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).
The viability of cochlear hair cells can evaluated by non-invasive measurement of otoacoustic (OAE) emissions which are low-intensity sounds from the cochlea (OAE).
Methods and materials:
The 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.
Expected outcome and perspectives:
From 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort with CNS infections
Otoacoustic emissions (OAE), Wide Band Tympanometry (WBT), Vestibular function tests. Audiometry. MOCA, eGOS are cognitive tests.
Biomarker is a protein found in the inner ear examined in the cerebral fluid.
Vestibular function
Vhit, Caloric test
OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
Biomarker
Biomarker examination
MOCA, eGOS
Cognitive tests
Audiometry
Hearing test
OAE/WBT control: Healthy individuals
Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.
OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
OAE/WBT control: Systemic infection
Otoacoustic emission during admission
OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
OAE/WBT control: ICP changes
Otoacoustic emission on patients without an CNS infection before and after elective lumbare puncture with measurement of intracranial pressure (ICP).
OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
Biomarker control
Inner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation.
Biomarker
Biomarker examination
Interventions
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Vestibular function
Vhit, Caloric test
OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
Biomarker
Biomarker examination
MOCA, eGOS
Cognitive tests
Audiometry
Hearing test
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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Hvidovre University Hospital
OTHER
Nordsjaellands Hospital
OTHER
Responsible Party
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Elisa Skovgaard Jensen
Principal Investigator
Principal Investigators
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Christian Brandt, MD
Role: STUDY_DIRECTOR
Department of infectious diseases
Locations
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Hillerød hospital
Hillerød, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PM52008
Identifier Type: -
Identifier Source: org_study_id
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