Evaluation of the effect of treatment with the Meniett in patients with unstable Menière*s disease.
ID
Source
Brief title
Condition
- Inner ear and VIIIth cranial nerve disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
frequency of the vertigo spells
Secondary outcome
duration of vertigo spells
functionality level scale
Dizziness Handicap Inventory
Hearing thresholds
Background summary
Menière*s disease is a disorder characterized by recurrent vertigo spells,
tinnitus and loss of hearing. These symptoms have a major impact on daily life
and severely reduce quality of life. Especially the recurrent vertigo spells
are disabling. The cause of Menière*s disease is unknown. However, there are
indications that the underlying pathology is endolymfatic hydrops, which is an
increase of endolymfatic fluid in the scala media of the cochlea.
At present no effective therapy is available. The current treatment of
Menière*s disease is aimed at reducing the endolymfatic hydrops.(diuretics,
salt restriction etc)
Animal studies suggest a hydrops can be reduced by applying positive pulse
pressure therapy to the inner ear. Based on these results a device, called the
Meniett was designed to produce positive pulse pressure waves.
Various clinical trials with the Meniett have been preformed, unfortunatly with
varying results. None of these trials have focused on the effect of the Meniett
in unstable Meniere disease. Theoretically, early treatment of unstable
Meniere's disease, before definite damage to the inner ear has occured,could
stop disease progression.
Study objective
Evaluation of the effect of treatment with the Meniett in patients with
unstable Menière*s disease.
Study design
A randomized dubbel-blind, placebo-controlled prospective cross-over study
Intervention
A tympanic tube will be inserted in all subject under lokal anesthesia. Two
weeks after insertion of the tympanic tube treatment will start. After
randomisation half of the patients will start the treatment with the Meniett,
half of the patients will start with the placebo.
Patients will use the Meniett for at least five minutes three times a day or
more frequently wit a maximum of 10 times a day if so desired. Patients will be
treated for 12 weeks with the Meniett or placebo and after a 2 week interval
cross over to the other treatment arm. There will be a 2 week follow-up period
after the treatment is ended.
Study burden and risks
The main risk in this study is formed by insertion of the tympanic tube.
Insertion of a tympanic tube is concidered a routine procedure in the ENT
practice. Some studies have suggested a positive effect of the tube insertion
in Menière*s disease. However conclusive proof has not been provided.
Treatment with the meniett device is a safe and non-invasive. Previous studies
with the Meniett have shown that no adverse events are to be expected.
This specific patient group continously requests attention from clinical
professionals, but hardly ever gets it. Therefore participants in this sudy
will probably not consider their participation in this study as a burden.
Heidelberglaan 100
3584 CX
NL
Heidelberglaan 100
3584 CX
NL
Listed location countries
Age
Inclusion criteria
defenite Menière acoording to the AAO-HNS:
two or more vertigo spells >20 minutes
audiometrically documented hearing loss at at least one occasion
Tinnitus or aural fullness in the treated ear
Other auses excluded
2. Instable Menière*s disease:
at least 3 vertigo spells en/or fluctuating hearing loss in the three months prior to inclusion
Exclusion criteria
controlateral pathology of the ear
ipsilateral pathology of the middle ear
chirurgic treatment for Menière*s disease
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 | NL16864.041.07 |