Determining a response characteristic of the vestibulocochlear nerve in healthy subjects (e.g. subjects without hearing loss or tinnitus), for the benefit of assessing possible aberrant characteristics in subjects with tinnitus, which data could be…
ID
Source
Brief title
Condition
- Aural disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Response characteristics of the vestibulocochlear nerve, such as latency,
amplitude and morphology.
Secondary outcome
N/a.
Background summary
Tinnitus is a condition for which the pathophysiology is unclear. There are
however a number of putative mechanisms that could explain the cause for (the
onset of) tinnitus. It is thought that the cochlear nucleus - as part of the
vestibulocochlear nerve - has a role in tinnitus-generating signals. The aim of
this study is to determine the response characteristics of the
vestibulocochlear nerve in healthy subjects (i.e. patients without hearing loss
or tinnitus), in order to assess possible aberrant functioning of this
structure in patients with tinnitus in future research projects.
Study objective
Determining a response characteristic of the vestibulocochlear nerve in healthy
subjects (e.g. subjects without hearing loss or tinnitus), for the benefit of
assessing possible aberrant characteristics in subjects with tinnitus, which
data could be gathered in future research projects.
Study design
This is an observational study. Patients undergoing the Jannetta procedure at
the UMCG, who have normal hearing (PTA <= 30 dBnHL) and who do not suffer from
tinnitus are included in this study.
During the Jannetta procedure, the vestibulocochlear nerve is exposed. The
recording electrode is placed on this structure, and the responses to differing
external stimuli are recorded. The external stimuli are provided by insert
earphones, connected to an ABR system, and will range in intensity levels,
rate, stimulus type and presence or absence of masking noise.
Study burden and risks
Before surgery, two tests are performed on a participant. An audiogram is made
and an ABR test is performed. These tests will take 60 minutes of time. The
actual research measurements take place during the surgery, so patients will
not suffer any burden from these measurements. None of the procedures expose
the participants to known risks.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
- Scheduled for a Jannetta procedure at the department of Neurosurgery;
- adult, aged 18 years or older;
- hearing threshold is smaller than or equal to 30 dBHL.
Exclusion criteria
- Non-conformance to any of the inclusion criteria;
- reported suffering from any type of tinnitus.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL58280.042.16 |