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CNS Infections Effect on the Inner Ear

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ClinicalTrials.gov Identifier: NCT03715569
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : October 23, 2018
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Elisa Skovgaard Jensen, Nordsjaellands Hospital

Brief Summary:
Study on patients with CNS infections.

Condition or disease Intervention/treatment
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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CNS Infections Effect on the Inner Ear
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cochlear damage [ Time Frame: Day1-90 ]
    Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.


Secondary Outcome Measures :
  1. Vestibular function loss [ Time Frame: 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 [ Time Frame: Day 1-90 ]
    Identify biomarkers, such as Cochlin, in CSF and assess their ability to predict sequelae.

  3. Cognitive impairment [ Time Frame: Day 90 ]
    Assess the frequency and serverity of cognitive impariment by using MOCA scores.


Biospecimen Retention:   Samples Without DNA
Cerebral fluid


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the hospital with a CNS infection.
Criteria

Inclusion Criteria:

  • Patients with a CNS infection admitted to the hospital.

Exclusion Criteria:

  • Patients with known hearing loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03715569


Contacts
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Contact: Elisa Skovgaard Jensen, MD +4530300969 elisa.skovgaard.jensen@regionh.dk
Contact: Christian Brandt, MD christian.thomas.brandt.01@regionh.dk

Locations
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Denmark
Hillerød hospital Recruiting
Hillerød, Denmark, 3400
Contact: Christian Brandt, MD       Christian.thomas.brandt.01@reigonh.dk   
Sponsors and Collaborators
Nordsjaellands Hospital
Hvidovre University Hospital
Investigators
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Study Director: Christian Brandt, MD Department of infectious diseases

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Responsible Party: Elisa Skovgaard Jensen, Principal Investigator, Nordsjaellands Hospital
ClinicalTrials.gov Identifier: NCT03715569     History of Changes
Other Study ID Numbers: PM52008
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Otitis
Central Nervous System Infections
Ear Diseases
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Labyrinthitis
Inflammation
Pathologic Processes
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Central Nervous System Diseases
Labyrinth Diseases