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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 : April 11, 2022
Sponsor:
Information provided by (Responsible Party):
Paul Dutcher, University of Rochester

Tracking Information
First Submitted Date  ICMJE April 27, 2018
First Posted Date  ICMJE May 9, 2018
Last Update Posted Date April 11, 2022
Actual Study Start Date  ICMJE January 29, 2019
Estimated Primary Completion Date February 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
  • 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
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of a Mastoid Device in Subjects With Ménière's Disease
Official Title  ICMJE A Prospective, Randomized, Blinded, Placebo-controlled, Single Center, Efficacy Study of a Mastoid Device in Subjects With Ménière's Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Meniere Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Mastoid Oscillator
    patients with Menieres Disease
    Intervention: Device: Mastoid Oscillator
  • Placebo Comparator: Control device
    patients with Menieres Disease
    Intervention: Device: Control Device
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 27, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2025
Estimated Primary Completion Date February 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03520322
Other Study ID Numbers  ICMJE RSRB 63989
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Paul Dutcher, University of Rochester
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Rochester
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Rochester
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP