CNS Infections Effect on the Inner Ear

Hearing Loss, Sensorineural Clinical Trial

Official title:

CNS Infections Effect on the Inner Ear

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03715569
• Other study ID #: PM52008
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Central Nervous System Infections
• CNS Infection
• Communicable Diseases
• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Infection
• Inflammation
• Inner Ear Hearing Loss
• Inner Ear Inflammation
• Labyrinthitis
• Otitis
• Vestibular Abnormality

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