Trial Outcomes & Findings for A Study of a Mastoid Device in Subjects With Ménière's Disease (NCT NCT03520322)
NCT ID: NCT03520322
Last Updated: 2024-12-12
Results Overview
A patient reported measure of the number of vertigo episodes they have experienced in the past month.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
7 participants
Primary outcome timeframe
Baseline to 90 days
Results posted on
2024-12-12
Participant Flow
One subject was consented but not randomized to the intervention.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of a Mastoid Device in Subjects With Ménière's Disease
Baseline characteristics by cohort
| Measure |
Mastoid Oscillator
n=3 Participants
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.
|
Control Device
n=3 Participants
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.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 90 daysA patient reported measure of the number of vertigo episodes they have experienced in the past month.
Outcome measures
| Measure |
Mastoid Oscillator
n=3 Participants
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.
|
Control Device
n=3 Participants
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.
|
|---|---|---|
|
Change in the Number of Monthly Vertigo Episodes
|
20.8 Episodes per month
Standard Deviation 26
|
22.2 Episodes per month
Standard Deviation 4.8
|
SECONDARY outcome
Timeframe: Baseline to 90 daysThe audiometric thresholds measured at 500 Hz, 1, 2, \& 4 kHz under controlled conditions are averaged together to create the average pure tone threshold
Outcome measures
| Measure |
Mastoid Oscillator
n=3 Participants
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.
|
Control Device
n=3 Participants
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.
|
|---|---|---|
|
Change in Average Pure Tone Threshold
|
6.0 Decibels
Standard Deviation 16.6
|
5.4 Decibels
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: Baseline to 90 daysA standard audiological evaluation of the percentage of words recognized from a list of 50 when played under controlled conditions
Outcome measures
| Measure |
Mastoid Oscillator
n=3 Participants
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.
|
Control Device
n=3 Participants
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.
|
|---|---|---|
|
Change in Percentage of Words Recognized
|
-8.7 percentage of words
Standard Deviation 12
|
1.3 percentage of words
Standard Deviation 6.5
|
SECONDARY outcome
Timeframe: Baseline to 90 daysA patient reported measure of their overall function from 0 to 6 where 0 corresponds to no symptoms and 6 corresponds to completely debilitated.
Outcome measures
| Measure |
Mastoid Oscillator
n=3 Participants
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.
|
Control Device
n=3 Participants
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.
|
|---|---|---|
|
Change in Meniere's Functional Level
|
-1 Score on a scale
Standard Deviation 0
|
0 Score on a scale
Standard Deviation 0
|
Adverse Events
Mastoid Oscillator
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Device
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Otolaryngology Research Program Manager
University of Rochester Medical Center
Phone: 5852751186
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place