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CNS Infections Effect on the Inner Ear

N

Nordsjaellands Hospital

Status

Unknown

Conditions

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

Treatments

Diagnostic Test: Biomarker
Diagnostic Test: MOCA, eGOS
Diagnostic Test: Vestibular function
Diagnostic Test: Audiometry
Diagnostic Test: OAE/WBT

Study type

Observational

Funder types

Other

Identifiers

NCT03715569
PM52008

Details and patient eligibility

About

Study on patients with CNS infections.

Full 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.

Enrollment

700 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients with a CNS infection admitted to the hospital.

Exclusion criteria

  • Patients with known hearing loss

Trial design

700 participants in 5 patient groups

Cohort with CNS infections
Description:
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.
Treatment:
Diagnostic Test: MOCA, eGOS
Diagnostic Test: Biomarker
Diagnostic Test: OAE/WBT
Diagnostic Test: Vestibular function
Diagnostic Test: Audiometry
OAE/WBT control: Healthy individuals
Description:
Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.
Treatment:
Diagnostic Test: OAE/WBT
OAE/WBT control: Systemic infection
Description:
Otoacoustic emission during admission
Treatment:
Diagnostic Test: OAE/WBT
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).
Treatment:
Diagnostic Test: OAE/WBT
Biomarker control
Description:
Inner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation.
Treatment:
Diagnostic Test: Biomarker

Trial contacts and locations

1

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Central trial contact

Christian Brandt, MD; Elisa Skovgaard Jensen, MD

Data sourced from clinicaltrials.gov

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