A Study of a Mastoid Device in Subjects With Ménière's Disease
Status
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to investigate the efficacy of a mastoid treatment device in patients with active Ménière's disease that is not controlled by traditional medical management
Full description
This is a single center, randomized, placebo-controlled trial of mastoid oscillation for treatment of Ménière's disease. Eligible subjects will be randomized using a 1:1 allocation to either mastoid oscillation or placebo (oscillator device that provides the same sound but no vibration of the mastoid) received for 30 minutes at four weekly study visits, with efficacy determination via change in frequency and severity of Ménière's symptoms following the final study visit.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Adults aged 18 and older
- Clinical diagnosis of Ménière's disease, with classical symptoms:
i. Episodic spinning vertigo ii. Fluctuating unilateral low frequency sensorineural hearing loss iii. Tinnitus iv. Aural fullness c. Failure of traditional medical management of Ménière's disease symptoms d. English language skills sufficient to provide informed consent to the study
Exclusion criteria
- Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
- Bilateral Ménière's disease
Trial design
Primary purpose
Allocation
Interventional model
Masking
7 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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