Primary objective: to investigate the prevalence of vestibulotoxicity and disturbance of equilibrium as far a Cystic Fibrosis patients with at least one treatment with tobramycin are concerned. Secondary objective: To formulate an advice for…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameter is formulated as whether there is damage to the
vestibulum or there is not.
Secondary outcome
Secundary study parameter is formulated as whether there is disturbance of
equilibrium due to damage of the vestibulum or there is not.
Background summary
Most of the CF patients were treated with repeated therapies of tobramycine.
Known and described are the cochleo-, vestibulo- and nephrotoxicity of
aminoglycoside, of which cochleotoxicity is familiar in clinical practice. CF
patients, like other patients with repeated therapy with aminoglycoside, are
being screened by pure tone audiometry. Research concerning vestibulotoxicty in
vivo, particularly in humans, is not established yet, with the exception of
some case reports.
This study is purposed to investigate the vestibulotoxicity due to
aminoglycoside with a clinical approach. Because CF patients are repeatedly
treated with aminoglycosides as well as frequently screened for hearing loss,
they form an interesting research population.
Our hypothesis is that CF patients with repeated tobramycin therapy do have an
elevated risk on vestibulotoxicity, and, therefore, has to be screened on
vestibular function in addition to screening for cochleotoxicity
Study objective
Primary objective:
to investigate the prevalence of vestibulotoxicity and disturbance of
equilibrium as far a Cystic Fibrosis patients with at least one treatment with
tobramycin are concerned.
Secondary objective:
To formulate an advice for possible screening for vestibulotoxicity with Cystic
Fibrosis patients with at least one treatment with tobramycin are concerned.
Study design
Observational cohort study
Study burden and risks
The burden associated with participation is concerned with an ENG investigation
(45 min.).
Preceding, the patient is asked to complete a questionnaire (5 min.) and the
patient will be seen by an independent ENT doctor. This doctor will have a look
using the microscope to exclude patients with perforation in the tympanic
membrane and will do a ordinary physical examination as far as the equilibrium
is concerned (10 min.).
All investigations are minimal invasive and none of them can harm the patient.
Leyweg 275
2445 CH Den Haag
Nederland
Leyweg 275
2445 CH Den Haag
Nederland
Listed location countries
Age
Inclusion criteria
cystic fibrosis patients currently known in the HAGA hospital who have been treated at least one time with intravenous tobramycin and with an audiogram in medical dossier
Exclusion criteria
patients treated with other intravenous aminoglycoside therapy than tobramycine
patients receiving intravenous aminoglycosides during investigation.
patients with perforation of one of the tympanic membranes.
patients with a radical cave.
Design
Recruitment
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL13333.098.06 |