CNS InfectionNCT03715569
CNS Infections Effect on the Inner Ear
An observational study of CNS Infection and Inner Ear Hearing Loss, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
Study on patients with CNS infections. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- CNS Infection, Inner Ear Hearing Loss, Vestibular Abnormality
- What is being tested?
- Vestibular function, OAE/WBT and Biomarker
- How many people
- 700 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Dec 2017to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted to the hospital with a CNS infection.
Who may be able to join
- Patients with a CNS infection admitted to the hospital.
Who cannot join
- Patients with known hearing loss
Trial locations and contacts
1 site in 1 country.
Christian Brandt, MD contact
Denmark1 site, 1 recruiting
- Recruiting
Hillerød hospital
Hillerød, 3400
Christian Brandt, MD, Christian.thomas.brandt.01@reigonh.dk
About this study
Study on patients with CNS infections.
Read the 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.
- Conditions
- CNS Infection, Inner Ear Hearing Loss, Vestibular Abnormality, Inner Ear Inflammation, Hearing Loss, Sensorineural
- Being tested
- Vestibular function, OAE/WBT, Biomarker, MOCA, eGOS, Audiometry
- Medical subject headings
- Central Nervous System Infections, Hearing Loss, Sensorineural, Labyrinth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular functionDiagnostic test
Vhit, Caloric test
OAE/WBTDiagnostic test
Oto acoustic emissions Wide Band Tympanometry
BiomarkerDiagnostic test
Biomarker examination
MOCA, eGOSDiagnostic test
Cognitive tests
AudiometryDiagnostic test
Hearing test
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Vestibular function; Diagnostic Test: OAE/WBT; Diagnostic Test: Biomarker; Diagnostic Test: MOCA, eGOS; Diagnostic Test: Audiometry | |
| OAE/WBT control: Healthy individuals | Otoacoustic emissions in normal position with head. Otoacoustic emission in different head positions. Receives: Diagnostic Test: OAE/WBT | |
| OAE/WBT control: Systemic infection | Otoacoustic emission during admission Receives: Diagnostic Test: OAE/WBT | |
| 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). Receives: Diagnostic Test: OAE/WBT | |
| Biomarker control | Inner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation. Receives: Diagnostic Test: Biomarker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cochlear damage
Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.
Measured: Day1-90
Secondary outcomes (3)
Vestibular function loss
Assess the frequency of vestibular function loss by using VHit and Caloic tests.
Measured: Day 1-90
Identifying biochemical markers in CSF during a CNS infection
Identify biomarkers, such as Cochlin, in CSF and assess their ability to predict sequelae.
Measured: Day 1-90
Cognitive impairment
Assess the frequency and serverity of cognitive impariment by using MOCA scores.
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Dec 2017
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CNS InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hvidovre University Hospital
- Responsible party
- Principal investigator, Elisa Skovgaard Jensen, Nordsjaellands Hospital
- Investigators
- Christian Brandt, MD, Study director, Department of infectious diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715569
- Sponsor's protocol ID
- PM52008
- Status last verified
- Oct 2018
- First submitted
- 1 Jun 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CNS Infections Effect on the Inner Ear
- ClinicalTrials.gov ID
- NCT03715569
- Acronym / sponsor ID
- PM52008
- Conditions
- CNS Infection, Inner Ear Hearing Loss, Vestibular Abnormality, Inner Ear Inflammation, Hearing Loss, Sensorineural
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Hvidovre University Hospital
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study on patients with CNS infections.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort with CNS infections | – | Diagnostic Test: Vestibular function, Diagnostic Test: OAE/WBT, Diagnostic Test: Biomarker, Diagnostic Test: MOCA, eGOS, Diagnostic Test: AudiometryOtoacoustic 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. |
| OAE/WBT control: Healthy individuals | – | Diagnostic Test: OAE/WBTOtoacoustic emissions in normal position with head. Otoacoustic emission in different head positions. |
| OAE/WBT control: Systemic infection | – | Diagnostic Test: OAE/WBTOtoacoustic emission during admission |
| OAE/WBT control: ICP changes | – | Diagnostic Test: OAE/WBTOtoacoustic emission on patients without an CNS infection before and after elective lumbare puncture with measurement of intracranial pressure (ICP). |
| Biomarker control | – | Diagnostic Test: BiomarkerInner ear biomarkers in patients without CNS infection. Inner ear fluid examination from patients that underwent elective cochlea implantation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the hospital with a CNS infection.
Key inclusion criteria (1 listed)
- Patients with a CNS infection admitted to the hospital.
Key exclusion criteria (1 listed)
- Patients with known hearing loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular functionVhit, Caloric test | Diagnostic test | Cohort with CNS infections |
| OAE/WBTOto acoustic emissions Wide Band Tympanometry | Diagnostic test | Cohort with CNS infections, OAE/WBT control: Healthy individuals, OAE/WBT control: ICP changes, OAE/WBT control: Systemic infection |
| BiomarkerBiomarker examination | Diagnostic test | Biomarker control, Cohort with CNS infections |
| MOCA, eGOSCognitive tests | Diagnostic test | Cohort with CNS infections |
| AudiometryHearing test | Diagnostic test | Cohort with CNS infections |
Primary outcome
Cochlear damage
Time frame: Day1-90
Assess the frequency and timely evolution of sensorineural hearing loss by using OAE/WBT and audiometry.
3 secondary outcomes
Vestibular function loss
Time frame: Day 1-90
Identifying biochemical markers in CSF during a CNS infection
Time frame: Day 1-90
Cognitive impairment
Time frame: Day 90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian Brandt, MD contact
Christian Brandt, MD study director
Department of infectious diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CNS Infection and Inner Ear Hearing Loss, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisa Skovgaard Jensen, MD (+4530300969, elisa.skovgaard.jensen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cochlear damage (time frame: Day1-90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.