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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03715569
Other study ID # PM52008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 1, 2017
Est. completion date December 1, 2020

Study information

Verified date October 2018
Source Nordsjaellands Hospital
Contact Elisa Skovgaard Jensen, MD
Phone +4530300969
Email elisa.skovgaard.jensen@regionh.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Study on patients with CNS infections.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 700
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Patients with a CNS infection admitted to the hospital.

Exclusion Criteria:

- Patients with known hearing loss

Study Design


Intervention

Diagnostic Test:
Vestibular function
Vhit, Caloric test
OAE/WBT
Oto acoustic emissions Wide Band Tympanometry
Biomarker
Biomarker examination
MOCA, eGOS
Cognitive tests
Audiometry
Hearing test

Locations

Country Name City State
Denmark Hillerød hospital Hillerød

Sponsors (2)

Lead Sponsor Collaborator
Nordsjaellands Hospital Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cochlear damage Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry. Day1-90
Secondary Vestibular function loss Assess the frequency of vestibular function loss by using VHit and Caloic tests. Day 1-90
Secondary Identifying biochemical markers in CSF during a CNS infection Identify biomarkers, such as Cochlin, in CSF and assess their ability to predict sequelae. Day 1-90
Secondary Cognitive impairment Assess the frequency and serverity of cognitive impariment by using MOCA scores. Day 90
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