1. Define diagnostic approach for patients with bilateral vestibulopathy.2. Define inclusion criteria for vestibular implantation.3. Investigate patient expectations of the vestibular implant. 4. To gain a clear insight into consumption of health…
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 defined diagnostic approach for patients with bilateral vestibulopathy.
2. Defined strict inclusion criteria for vestibular implantation
3. A detailed insight in the patient expectations of the vestibular implant
4. A detailed insight into consumption of health care by patients with
bilateral vestibulopathy
Secondary outcome
Not applicable
Background summary
Bilateral vestibulopathy (BV) represents a major handicap with strong balance
disturbances, higher risk of fall, visual symptoms (oscillopsia) and 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 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. Define diagnostic approach for patients with bilateral vestibulopathy.
2. Define inclusion criteria for vestibular implantation.
3. Investigate patient expectations of the vestibular implant.
4. To gain a clear insight into consumption of health care by patients with
bilateral vestibulopathy.
Study design
Observational study
Study burden and risks
After returning written informed consent, selected patients will undergo:
- Detailed interview (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 visits (when 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 4
hours), which are routinely perfermed 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. One week before
visiting the ENT department, the patient wil wear a motion sensor. This is al
very small en light device en will have no burden for the patient. All test can
be performed at one day. The major burden for the patient is time: one day is
spent at our department in Maastricht.
P. Debeyelaan 25
Maastricht 6202 AZ
NL
P. Debeyelaan 25
Maastricht 6202 AZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Bilateral vestibulopathy, diagnosed at Maastricht University Medical Center
according to the Bárány criteria:
* Horizontal angular VOR gain bilaterally <0.6
* And/or sum of the maximal peak velocities of the slow phase caloric induced
nystagmus (stimulation with warm and cold water) bilaterally <6°/s
* And/or VOR gain <0.1 upon sinusoidal stimulation on torsion swing test
(and/or a phase lead >68 degrees on torsion swing test)
- >18 years old
- Giving informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- 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.
- Not being able to stop medication against anxiety or depression (after
consulting their general practitioner)
- Not wanting to be informed about any incidental findings
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 | NL72200.068.19 |
| OMON | NL-OMON21431 |