To evaluate the vestibular function relating results to surgery, radiotherapy, active surveillance, intratympanic gentamicin, and intratympanic gentamicin followed by active treatment based on objective vestibular testing and dizziness related QoL…
ID
Source
Brief title
Condition
- Other condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Health condition
vestibular function
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The changes in objective vestibular test results and dizziness related QoL
during follow-up.
Secondary outcome
• To correlate the pre-operative vestibular function with the post-operative
patient vestibular disability and handicap.
• To correlate the irradiation dose-volume to the vestibular organs with
vestibulo-toxicity after radiotherapy.
• To correlate the natural development of the vestibular function over time in
active surveillance.
• To determine the effect of ITG in the vestibular function and vestibular
complaints, with objective and subjective vestibular tests.
• To correlate the questionnaires (DHI, PANQOL and SF-36) results with
vestibular function.
Background summary
Vestibular schwannoma (VS) is a rare, benign tumour arising from the Schwann
cells of the vestibular nerve. It is commonly associated with tinnitus and
sensorineural hearing loss. Moreover, it is a tumour that grows in the
vestibular nerve and thus has the ability to affect the vestibular function.
The majority of patients with a vestibular schwannoma will present with
asymmetric hearing loss and/or vestibular complaints such as balance
disturbance or vertigo. It has been demonstrated that the vestibular symptoms
have a major impact on the quality of life of vestibular schwannoma patients.
It is therefore of paramount clinical importance to evaluate vestibular
function in this patient group and gain insight into the progression of these
symptoms over time, in relation to the vestibular schwannoma management
strategy.
Up to now, no prospective study has been performed evaluating vestibular
function in VS patients. The current study will focus on vestibular function in
relation to vestibular schwannoma management strategies: surgery, radiotherapy,
active surveillance (wait and scan policy), or intratympanic gentamicin
followed by active treatment (surgery or radiotherapy). The variables that will
be studied include dizziness, vertigo, hearing loss, cognitive-psychological
function. The primary aim is to evaluate vestibular function and vestibular
compensation processes over time and in relation to treatment strategy and
patient characteristics.
Study objective
To evaluate the vestibular function relating results to surgery, radiotherapy,
active surveillance, intratympanic gentamicin, and intratympanic gentamicin
followed by active treatment based on objective vestibular testing and
dizziness related QoL.
Study design
Prospective observational single-center cohort study.
Study burden and risks
The VS patients will be subjected to standard clinical care and diagnostics,
with the exception of objectibe vestibular function assessments.
The vestibular tests used in this study are well-established, not experimental
in themselves, and do not represent risk for the patient. We consider the risk
of participating in this study to be negligible.
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
• aged 18 years or older
• being diagnosed with unilateral vestibular schwannoma
• with or without active VS treatment indication (i.e. RT, S or AS)
• with or without severe vestibular signs or symptoms
• able to provide a written informed consent
Exclusion criteria
• active additional neuro- otologic disorders
• severe disability (e.g. neurological, cardiovascular, orthopedic,
psychiatric) or
• serious concurrent illness that might interfere with vestibular evaluation
• patients under medical treatment that affects the vestibular function
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL74697.058.20 |
Other | NL9176 |
OMON | NL-OMON27070 |