CNS Infections Effect on the Inner Ear

Sponsor

Nordsjaellands Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03715569

Collaborator

Hvidovre University Hospital (Other)

700

Enrollment

Location

Anticipated Duration (Months)

19.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Study on patients with CNS infections.

Condition or Disease	Intervention/Treatment	Phase
CNS Infection Inner Ear Hearing Loss Vestibular Abnormality Inner Ear Inflammation Hearing Loss, Sensorineural	Diagnostic Test: Vestibular function Diagnostic Test: OAE/WBT Diagnostic Test: Biomarker Diagnostic Test: MOCA, eGOS Diagnostic Test: Audiometry

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 Design

Study Type:

Observational

Anticipated Enrollment :

700 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

CNS Infections Effect on the Inner Ear

Actual Study Start Date :

Dec 1, 2017

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2020

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

Cochlear damage [Day1-90]
Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.

Secondary Outcome Measures

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