Meniere Disease Clinical Trial
Official title:
A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
Verified date | April 2023 |
Source | University of Rochester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Enrolling by invitation |
Enrollment | 30 |
Est. completion date | February 1, 2025 |
Est. primary completion date | February 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Adults aged 18 and older 2. 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: 1. Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis 2. Bilateral Ménière's disease |
Country | Name | City | State |
---|---|---|---|
United States | 2365 S. Clinton Ave | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
University of Rochester |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline to 90 days | |
Secondary | 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 | Baseline to 90 days | |
Secondary | 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 | Baseline to 90 days | |
Secondary | 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. | Baseline to 90 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04835688 -
Ventilation Tube Insertion for Unilateral Menière's Disease
|
N/A | |
Recruiting |
NCT05851508 -
The Effecttiveness of Intratympanic Methylprednisolon Injections Compared to Placebo in the Treatment of Vertigo Attacks in Meniere's Disease
|
Phase 3 | |
Not yet recruiting |
NCT05322538 -
Menier's Disease - Bone Density Study
|
N/A | |
Completed |
NCT05328895 -
Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease
|
N/A | |
Completed |
NCT04569175 -
Non Enhanced Labyrinth Imaging for the Detection of Endolymphatic Hydrops in Meniere's Disease "NELI Study"
|
N/A | |
Not yet recruiting |
NCT05582148 -
Meniere Disease and Hearing Aids
|
N/A | |
Completed |
NCT05844657 -
Comprehensive Evaluation in Patients With Meniere's Disease
|
||
Completed |
NCT04902963 -
What is the Tympanic Membrane Healing Time After Insertion of a Gelfoam PE Tube?
|
N/A | |
Completed |
NCT04686695 -
Transcutaneous Auricular Vagus Nerve Stimulation Treatment on Meniere Disease
|
N/A | |
Recruiting |
NCT04815187 -
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
|
Phase 4 | |
Recruiting |
NCT06278129 -
Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease
|
||
Recruiting |
NCT04766853 -
Verification of the Efficacy/Safety of the Intratympanic Drug Delivery for Hearing Loss
|
Phase 1/Phase 2 | |
Recruiting |
NCT04370366 -
Imaging of Endolymphatic Hydrops at 7T MRI
|
||
Withdrawn |
NCT04674735 -
Safety of APSLXR in Patients Presenting Vertigo of Vestibular Origin or Meniere's Disease
|
Phase 1 | |
Not yet recruiting |
NCT05424302 -
Effect of Peripheral Vestibular Disease Location on Outcomes Following Home-based Virtual Reality Vestibular Therapy
|
N/A | |
Recruiting |
NCT03795675 -
CI Following VS Removal or Labyrinthectomy
|
N/A | |
Completed |
NCT04218123 -
Assessing the Efficacy of a Serotonin and Norepinephrine Reuptake Inhibitor for Improving Meniere's Disease Outcomes
|
Phase 2/Phase 3 | |
Withdrawn |
NCT02371798 -
Unilateral Meniere Disease: Can Double Dose Gadolinium and Delayed Imaging Make the Diagnosis?
|
N/A | |
Completed |
NCT05960786 -
Treating the Symptoms of Vertigo in a Real-world Setting Using the OtoBand
|
N/A | |
Terminated |
NCT02529475 -
Evaluation of Inner Ear and Brain Structures With Contrast-enhanced MRI in Healthy Subjects (HYDROPS)
|
Phase 4 |