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

NCT03520322 | Terminated Results FDA Device

• 1 other identifier: RSRB 63989
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Conditions

Meniere Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Average Pure Tone Threshold

  Baseline to 90 days

• Change in Percentage of Words Recognized

  Baseline to 90 days

• Change in Meniere's Functional Level

  Baseline to 90 days

Study Arms (2)

Mastoid Oscillator

EXPERIMENTAL

patients with Menieres Disease

Device: Mastoid Oscillator

Control device

PLACEBO COMPARATOR

patients with Menieres Disease

Device: Control Device

Interventions

Mastoid Oscillator DEVICE

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.

Mastoid Oscillator

Control Device 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.

Control device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Atypical medical history of Ménière's symptoms and questionable Ménière's diagnosis
• Bilateral Ménière's disease

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

2365 S. Clinton Ave

Rochester, New York, 14618, United States

Location

MeSH Terms

Conditions

Meniere Disease

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Otolaryngology Research Program Manager
• Organization: University of Rochester Medical Center

paul_allen@urmc.rochester.edu

5852751186

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 9, 2018
• Study Start: January 29, 2019
• Primary Completion: February 14, 2024
• Study Completion: December 4, 2024
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)