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CNS Infections Effect on the Inner Ear

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StatusRecrutamento
Patrocinadores
Nordsjaellands Hospital
Colaboradores
Hvidovre University Hospital

Palavras-chave

Resumo

Study on patients with CNS infections.

Descrição

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.

datas

Última verificação: 09/30/2018
Enviado pela primeira vez: 05/31/2018
Inscrição estimada enviada: 10/17/2018
Postado pela primeira vez: 10/22/2018
Última atualização enviada: 10/17/2018
Última atualização postada: 10/22/2018
Data real de início do estudo: 11/30/2017
Data Estimada de Conclusão Primária: 11/30/2020
Data Estimada de Conclusão do Estudo: 11/30/2020

Condição ou doença

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

Intervenção / tratamento

Diagnostic Test: Cohort with CNS infections

Diagnostic Test: OAE/WBT

Diagnostic Test: Biomarker

Diagnostic Test: Cohort with CNS infections

Diagnostic Test: Cohort with CNS infections

Fase

-

Grupos de Armas

BraçoIntervenção / tratamento
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: Cohort with CNS infections
Vhit, Caloric test
OAE/WBT control: Healthy individuals
Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions.
OAE/WBT control: Systemic infection
Otoacoustic emission during admission
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).
Biomarker control
Inner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation.

Critério de eleição

Idades qualificadas para estudar 18 Years Para 18 Years
Sexos elegíveis para estudoAll
Método de amostragemNon-Probability Sample
Aceita Voluntários Saudáveissim
Critério

Inclusion Criteria:

- Patients with a CNS infection admitted to the hospital.

Exclusion Criteria:

- Patients with known hearing loss

Resultado

Medidas de Resultado Primário

1. Cochlear damage [Day1-90]

Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.

Medidas de Resultado Secundário

1. Vestibular function loss [Day 1-90]

Assess the frequency of vestibular function loss by using VHit and Caloic tests.

2. 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.

3. Cognitive impairment [Day 90]

Assess the frequency and serverity of cognitive impariment by using MOCA scores.

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