To gain information about the characteristics of the oVEMP-response in patients with otosclerosis and to objectify the complaints of dizziness pre- and postoperatively through a dizziness questionnaire.
ID
Source
Brief title
Condition
- Middle ear disorders (excl congenital)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the amplitude and the threshold of the
oVEMP-response.
Secondary outcome
Other characteristics of the oVEMP-response which will be studied are the
latencies of the various peaks in the response. All variables will be studied
in relation to the level of the oVEMP-evoking stimulus. The final variable
that will be studied is the dizzyness questionnaire (Dizzyness Handicap
Inventory) pre- and postoperatively.
Background summary
In patients with otosclerosis hearing loss is the main complaint, but some
patients complain of dizziness. The location of the diseased bone in
otosclerosis at the stapes footplate is in close proximity to the otolithic
organs, and surgery is also performed at this specific location. The original
disease and the surgery itself could influence the function of the otolithic
organs. Because the oVEMP-test is a way of testing the otolith function
possible differences in oVEMP-response in otosclerosis patients will be
compared to our clinical standard.
Study objective
To gain information about the characteristics of the oVEMP-response in patients
with otosclerosis and to objectify the complaints of dizziness pre- and
postoperatively through a dizziness questionnaire.
Study design
A cohort of patients with otosclerosis will be tested and the results will be
compared to our clinical standards (20 healthy volunteers).
Study burden and risks
For this study patients will have to visit the UMCU twice for the oVEMP-test.
Each visit will take less than two hours, thus for the complete study this will
be less than four hours. For the oVEMP-test 5 electrodes will be placed on the
face of the patient and a bone-conducted stimulus will be delivered to the
patient in supine position with raised eyes. The potentials risks of the
oVEMP-test are very small. The bone-conducted stimulus can be experienced as
uncomfortable, but is not painful and will not damage the auditory system.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
Otosclerosis with indication for stapedectomy
Age >= 18 years
Exclusion criteria
An interfering cause of vertigo
History of eye-motility disorders
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 | NL31051.041.09 |