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Device
Mastoid Oscillator for Meniere's Disease
N/A
Waitlist Available
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 90 days
Awards & highlights
Study Summary
This trial is testing a new device to treat Ménière's disease, to see if it is more effective than current medical treatments.
Who is the study for?
This trial is for adults over 18 with Ménière's disease, who experience spinning vertigo, hearing loss in low frequencies, tinnitus (ringing in the ears), and a feeling of fullness in the ear. They should have tried traditional treatments without success and must speak English well enough to consent.Check my eligibility
What is being tested?
The study tests a mastoid treatment device against a control device to see if it can help manage symptoms of Ménière's disease when standard medical treatments don't work.See study design
What are the potential side effects?
Potential side effects are not specified here but could include discomfort or other sensations around the ear due to the use of the mastoid oscillator or control device.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in the number of monthly vertigo episodes
Secondary outcome measures
Change in Meniere's functional level
Change in average pure tone threshold
Change in word recognition score
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mastoid OscillatorExperimental Treatment1 Intervention
patients with Menieres Disease
Group II: Control devicePlacebo Group1 Intervention
patients with Menieres Disease
Find a Location
Who is running the clinical trial?
University of RochesterLead Sponsor
837 Previous Clinical Trials
518,163 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have Ménière's disease with vertigo, hearing loss, tinnitus, ear fullness, and treatments haven't worked.I have Ménière's disease in both ears.I am 18 years old or older.My diagnosis of Ménière's disease is uncertain.You have a condition called Ménière's disease which causes spinning vertigo, hearing loss, ringing in your ears, and a feeling of fullness in your ear. You have tried traditional medical treatments but they haven't worked. You must be able to speak and understand English well enough to give permission for the study.
Research Study Groups:
This trial has the following groups:- Group 1: Mastoid Oscillator
- Group 2: Control device
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any slots remaining for participants in this experiment?
"Per clinicaltrials.gov, this medical study is not currently recruiting participants. Initially posted on January 29th 2019 and last edited April 8th 2022, the trial has concluded recruitment for now; however there are 16 other trials actively seeking volunteers at present."
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