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CNS Infections Effect on the Inner Ear

CNS Infections Effect on the Inner Ear

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03715569
Enrollment
700
Registered
2018-10-23
Start date
2017-12-01
Completion date
2020-12-01
Last updated
2018-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CNS Infection, Inner Ear Hearing Loss, Vestibular Abnormality, Inner Ear Inflammation, Hearing Loss, Sensorineural

Brief summary

Study on patients with CNS infections.

Detailed description

Aims and objectives: 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.

Interventions

DIAGNOSTIC_TESTVestibular function

Vhit, Caloric test

DIAGNOSTIC_TESTOAE/WBT

Oto acoustic emissions Wide Band Tympanometry

DIAGNOSTIC_TESTBiomarker

Biomarker examination

DIAGNOSTIC_TESTMOCA, eGOS

Cognitive tests

DIAGNOSTIC_TESTAudiometry

Hearing test

Sponsors

Hvidovre University Hospital
CollaboratorOTHER
Nordsjaellands Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with a CNS infection admitted to the hospital.

Exclusion criteria

* Patients with known hearing loss

Design outcomes

Primary

MeasureTime frameDescription
Cochlear damageDay1-90Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.

Secondary

MeasureTime frameDescription
Vestibular function lossDay 1-90Assess the frequency of vestibular function loss by using VHit and Caloic tests.
Identifying biochemical markers in CSF during a CNS infectionDay 1-90Identify biomarkers, such as Cochlin, in CSF and assess their ability to predict sequelae.
Cognitive impairmentDay 90Assess the frequency and serverity of cognitive impariment by using MOCA scores.

Countries

Denmark

Contacts

Primary ContactElisa Skovgaard Jensen, MD
elisa.skovgaard.jensen@regionh.dk+4530300969
Backup ContactChristian Brandt, MD
christian.thomas.brandt.01@regionh.dk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026