Back to resultsA Study of a Mastoid Device in Subjects With Ménière's Disease
Primary Purpose
Meniere Disease
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mastoid Oscillator
Control Device
Sponsored by
About this trial
This is an interventional treatment trial for Meniere Disease
Eligibility Criteria
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
Sites / Locations
- 2365 S. Clinton Ave
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mastoid Oscillator
Control device
Arm Description
patients with Menieres Disease
patients with Menieres Disease
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Change in word recognition score
A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03520322
Brief Title
A Study of a Mastoid Device in Subjects With Ménière's Disease
Official Title
A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
February 1, 2024 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meniere Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mastoid Oscillator
Arm Type
Experimental
Arm Description
patients with Menieres Disease
Arm Title
Control device
Arm Type
Placebo Comparator
Arm Description
patients with Menieres Disease
Intervention Type
Device
Intervention Name(s)
Mastoid Oscillator
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Control Device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the number of monthly vertigo episodes
Description
A patient reported measure of the number of vertigo episodes they have experienced in the past month.
Time Frame
Baseline to 90 days
Secondary Outcome Measure Information:
Title
Change in average pure tone threshold
Description
The audiometric thresholds measured at 500 Hz, 1, 2, & 4 kHz under controlled conditions are averaged together to create the average pure tone threshold
Time Frame
Baseline to 90 days
Title
Change in word recognition score
Description
A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
Time Frame
Baseline to 90 days
Title
Change in Meniere's functional level
Description
A patient reported measure of their overall function from 0 to 6 where 0 corresponds to no symptoms and 6 corresponds to completely debilitated.
Time Frame
Baseline to 90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
2365 S. Clinton Ave
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of a Mastoid Device in Subjects With Ménière's Disease
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