CNS Infections Effect on the Inner Ear

NCT ID: NCT03715569

Last Updated: 2018-10-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-12-01

Brief Summary

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Study on patients with CNS infections.

Detailed Description

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type DIAGNOSTIC_TEST

Vhit, Caloric test

OAE/WBT

Intervention Type DIAGNOSTIC_TEST

Oto acoustic emissions Wide Band Tympanometry

Biomarker

Intervention Type DIAGNOSTIC_TEST

Biomarker examination

MOCA, eGOS

Intervention Type DIAGNOSTIC_TEST

Cognitive tests

Audiometry

Intervention Type DIAGNOSTIC_TEST

Hearing test

OAE/WBT control: Healthy individuals

Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.

OAE/WBT

Intervention Type DIAGNOSTIC_TEST

Oto acoustic emissions Wide Band Tympanometry

OAE/WBT control: Systemic infection

Otoacoustic emission during admission

OAE/WBT

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Biomarker examination

Interventions

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Vestibular function

Vhit, Caloric test

Intervention Type DIAGNOSTIC_TEST

OAE/WBT

Oto acoustic emissions Wide Band Tympanometry

Intervention Type DIAGNOSTIC_TEST

Biomarker

Biomarker examination

Intervention Type DIAGNOSTIC_TEST

MOCA, eGOS

Cognitive tests

Intervention Type DIAGNOSTIC_TEST

Audiometry

Hearing test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with a CNS infection admitted to the hospital.

Exclusion Criteria

* Patients with known hearing loss
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hvidovre University Hospital

OTHER

Sponsor Role collaborator

Nordsjaellands Hospital

OTHER

Sponsor Role lead

Responsible Party

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Elisa Skovgaard Jensen

Principal Investigator

Responsibility Role 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

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Elisa Skovgaard Jensen, MD

Role: CONTACT

+4530300969

Christian Brandt, MD

Role: CONTACT

Facility Contacts

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Christian Brandt, MD

Role: primary

Other Identifiers

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PM52008

Identifier Type: -

Identifier Source: org_study_id

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