CNS Infections Effect on the Inner Ear

October 18, 2018 updated by: Elisa Skovgaard Jensen, Nordsjaellands Hospital
Study on patients with CNS infections.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the hospital with a CNS infection.

Description

Inclusion Criteria:

  • Patients with a CNS infection admitted to the hospital.

Exclusion Criteria:

  • Patients with known hearing loss

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: Vestibular function
Vhit, Caloric test
Diagnostic test: OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
Diagnostic test: Biomarker
Biomarker examination
Diagnostic test: MOCA, eGOS
Cognitive tests
Diagnostic test: Audiometry
Hearing test
OAE/WBT control: Healthy individuals
Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.
Diagnostic test: OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
OAE/WBT control: Systemic infection
Otoacoustic emission during admission
Diagnostic test: 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).
Diagnostic test: 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.
Diagnostic test: Biomarker
Biomarker examination

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cochlear damage
Time Frame: Day1-90
Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.
Day1-90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vestibular function loss
Time Frame: Day 1-90
Assess the frequency of vestibular function loss by using VHit and Caloic tests.
Day 1-90
Identifying biochemical markers in CSF during a CNS infection
Time Frame: Day 1-90
Identify biomarkers, such as Cochlin, in CSF and assess their ability to predict sequelae.
Day 1-90
Cognitive impairment
Time Frame: Day 90
Assess the frequency and serverity of cognitive impariment by using MOCA scores.
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordsjaellands Hospital

Collaborators

Hvidovre University Hospital

Investigators

  • Study Director: Christian Brandt, MD, Department of Infectious Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

June 1, 2018

First Submitted That Met QC Criteria

October 18, 2018

First Posted (ACTUAL)

October 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PM52008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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