1. Investigate health care consumption of patients with bilateral vestibulopathy2. Investigate patient expectations of the vestibular implant3. Define inclusion criteria for vestibular implantation4. Define diagnostic approach for patients with…
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. A detailed overview of the health care consumption of patients with
bilateral vestibulopathy
2. A detailed insight in the patient expectations of the vestibular implant
3. Defined strict inclusion criteria for vestibular implantation
4. A defined diagnostic approach for patients with bilateral vestibulopathy
Secondary outcome
not applicable
Background summary
Bilateral vestibular loss (BV) represents a major handicap with strong balance
disturbances, higher risk of fall, visual symptoms (oscillopsia) and a loss of
autonomy.
Prognosis is poor and treatment options are limited. At this moment, the
department of ORL of Maastricht University Medical Center is working on a
vestibular implant. Aim is to (partially) restore vestibular function.
However literature about the costs and burden of BV are scarce. Moreover, there
is no consensus regarding vestibular testing procedures and the characteristics
that define BV. These are all important parameters for the implementation of
the vestibular implant as a regular therapeutic device.
Study objective
1. Investigate health care consumption of patients with bilateral vestibulopathy
2. Investigate patient expectations of the vestibular implant
3. Define inclusion criteria for vestibular implantation
4. Define diagnostic approach for patients with bilateral vestibulopathy
Study design
Observational Study
Study burden and risks
After returning written informed consent, selected patients will undergo:
- Detailed interview (about 1 hour). No burden is expected for the patients,
except time. One could hypothesize a psychological burden since patients will
be interviewed about their past psychological/psychiatric history. However,
this issue has already been addressed during their previous regular visits
(when the diagnosis was made). Until now, no patients have refused or felt
uncomfortable to inform us about their past medical history. If so, these
patients will be excluded and not invited for the study.
- An extensive physical, audiometric and vestibular examination (about 3
hours), which are routinely performed at our ENT-department, to investigate
patients with balance disorders. Due to the nature of their disease (bilateral
vestibulopathy), these patients will not get sick by these tests, compared to
persons with a still (partially) intact vestibular function.
All tests can be performed at one day. The major burden for the patient is
time: one day is spent at our department in Maastricht.
Furstenweg 77a
Innsbruck A-6020
AT
Furstenweg 77a
Innsbruck A-6020
AT
Listed location countries
Age
Inclusion criteria
- Bilateral vestibulopathy, diagnosed at Maastricht University Medical Center
- >18 years old
- Giving informed consent
Exclusion criteria
- Not being able (e.g. mentally disabled) or willing to talk about one of the investigated issues (e.g. psychology/psychiatry, health care utilization
- Not being able or willing to undergo one of the detailed physical, audiometric or vestibular examinations.
- Incapacitated patients
Design
Recruitment
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 | NL52768.068.15 |
| OMON | NL-OMON20731 |