Meniere Disease
Conditions
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.
Interventions
DEVICEMastoid 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.
DEVICEControl 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.
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Number of Monthly Vertigo Episodes | Baseline to 90 days | A patient reported measure of the number of vertigo episodes they have experienced in the past month. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Percentage of Words Recognized | 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 | 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. |
| Change in Average Pure Tone Threshold | 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 |
Countries
United States
Participant flow
Pre-assignment details
One subject was consented but not randomized to the intervention.
Participants by arm
| Arm | Count |
|---|---|
| Mastoid Oscillator patients with Menieres Disease
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. | 3 |
| Control Device patients with Menieres Disease
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. | 3 |
| Total | 6 |
Baseline characteristics
| Characteristic | Mastoid Oscillator | Control Device | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 3 Participants | 6 Participants |
| Region of Enrollment United States | 3 participants | 3 participants | 6 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 3 |
| other Total, other adverse events | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 |
Outcome results
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.
Time frame: Baseline to 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mastoid Oscillator | Change in the Number of Monthly Vertigo Episodes | 20.8 Episodes per month | Standard Deviation 26 |
| Control Device | Change in the Number of Monthly Vertigo Episodes | 22.2 Episodes per month | Standard Deviation 4.8 |
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
Time frame: Baseline to 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mastoid Oscillator | Change in Average Pure Tone Threshold | 6.0 Decibels | Standard Deviation 16.6 |
| Control Device | Change in Average Pure Tone Threshold | 5.4 Decibels | Standard Deviation 7.8 |
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.
Time frame: Baseline to 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mastoid Oscillator | Change in Meniere's Functional Level | -1 Score on a scale | Standard Deviation 0 |
| Control Device | Change in Meniere's Functional Level | 0 Score on a scale | Standard Deviation 0 |
Secondary
Change in Percentage of Words Recognized
A standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
Time frame: Baseline to 90 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mastoid Oscillator | Change in Percentage of Words Recognized | -8.7 percentage of words | Standard Deviation 12 |
| Control Device | Change in Percentage of Words Recognized | 1.3 percentage of words | Standard Deviation 6.5 |