Meniere DiseaseNCT03520322
A Study of a Mastoid Device in Subjects With Ménière's Disease
A study testing Mastoid Oscillator in people with Meniere Disease, run by University of Rochester at 1 site in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Meniere Disease
- What is being tested?
- Mastoid Oscillator
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2019to 4 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older
- Clinical diagnosis of Ménière's disease, with classical symptoms:
- 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
Who cannot join
- Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
- Bilateral Ménière's disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
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
Read the detailed 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.
- Conditions
- Meniere Disease
- Being tested
- Mastoid Oscillator, Control Device
- Medical subject headings
- Meniere Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mastoid OscillatorDevice
The oscillator will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.
Control DeviceDevice
The control device will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Mastoid Oscillator | Experimental | patients with Menieres Disease Receives: Device: Mastoid Oscillator |
| Control device | Placebo comparator | patients with Menieres Disease Receives: Device: Control Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Number of Monthly Vertigo Episodes
A patient reported measure of the number of vertigo episodes they have experienced in the past month.
Measured: Baseline to 90 days
Secondary outcomes (3)
Change in Average Pure Tone Threshold
The audiometric thresholds measured at 500 Hz, 1, 2, \& 4 kHz under controlled conditions are averaged together to create the average pure tone threshold
Measured: Baseline to 90 days
Change in Percentage of Words Recognized
A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
Measured: Baseline to 90 days
Change in Meniere's Functional Level
A patient reported measure of their overall function from 0 to 6 where 0 corresponds to no symptoms and 6 corresponds to completely debilitated.
Measured: Baseline to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start29 Jan 2019
- Primary completion14 Feb 2024
- Study completion4 Dec 2024
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meniere DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520322
- Sponsor's protocol ID
- RSRB 63989
- Status last verified
- Dec 2024
- First submitted
- 27 Apr 2018
- Last updated
- 12 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
- ClinicalTrials.gov ID
- NCT03520322
- Acronym / sponsor ID
- RSRB 63989
- Conditions
- Meniere Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 29 Jan 2019 (actual)
- Primary completion
- 14 Feb 2024 (actual)
- Study completion
- 4 Dec 2024 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Posted 12 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mastoid Oscillator | Experimental | Device: Mastoid Oscillatorpatients with Menieres Disease |
| Control device | Placebo comparator | Device: Control Devicepatients with Menieres Disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 and older
- Clinical diagnosis of Ménière's disease, with classical symptoms:
- 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
Key exclusion criteria (2 listed)
- Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
- Bilateral Ménière's disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mastoid OscillatorThe oscillator will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes. | Device | Mastoid Oscillator |
| Control DeviceThe control device will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes. | Device | Control device |
Primary outcome
Change in the Number of Monthly Vertigo Episodes
Time frame: Baseline to 90 days
A patient reported measure of the number of vertigo episodes they have experienced in the past month.
3 secondary outcomes
Change in Average Pure Tone Threshold
Time frame: Baseline to 90 days
Change in Percentage of Words Recognized
Time frame: Baseline to 90 days
Change in Meniere's Functional Level
Time frame: Baseline to 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mastoid Oscillator in people with Meniere Disease, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Number of Monthly Vertigo Episodes (time frame: Baseline to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.