Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of a Mastoid Device in Subjects With Ménière's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03520322
Recruitment Status : Enrolling by invitation
First Posted : May 9, 2018
Last Update Posted : March 11, 2021
Sponsor:
Information provided by (Responsible Party):
Paul Dutcher, University of Rochester

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

Condition or disease Intervention/treatment Phase
Meniere Disease Device: Mastoid Oscillator Device: Control Device Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mastoid Oscillator
patients with Menieres Disease
Device: Mastoid Oscillator
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.

Placebo Comparator: Control device
patients with Menieres Disease
Device: Control Device
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 Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in average pure tone threshold [ Time Frame: Baseline to 90 days ]
    The audiometric thresholds measured at 500 Hz, 1, 2, & 4 kHz under controlled conditions are averaged together to create the average pure tone threshold

  2. Change in word recognition score [ Time Frame: Baseline to 90 days ]
    A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions

  3. Change in Meniere's functional level [ Time Frame: Baseline to 90 days ]
    A patient reported measure of their overall function from 0 to 6 where 0 corresponds to no symptoms and 6 corresponds to completely debilitated.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520322


Locations
Layout table for location information
United States, New York
2365 S. Clinton Ave
Rochester, New York, United States, 14618
Sponsors and Collaborators
University of Rochester
Layout table for additonal information
Responsible Party: Paul Dutcher, Associate Professor of Clinical Otolaryngology, University of Rochester
ClinicalTrials.gov Identifier: NCT03520322    
Other Study ID Numbers: RSRB 63989
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: March 11, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases