This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for A Study of a Mastoid Device in Subjects With Ménière's Disease (NCT03520322), a randomized na study. The primary outcome is Change in the Number of Monthly Vertigo Episodes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03520322 |
| Phase | NA |
| Condition | Meniere Disease |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 7 |
| Arms in the primary outcome | 2 |
| Lead sponsor | University of Rochester |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned people with active Ménière's disease that was not controlled by traditional medical management. The registry lists Meniere Disease as the condition. The endpoint summary includes 3 participants in each arm, while the overall enrollment is listed as 7. The record does not explain the difference between these counts or provide further details about the participants represented in the endpoint summaries.
Intervention
The intervention was a device named Mastoid Oscillator. The registry describes the study as investigating a mastoid treatment device, but does not report further operational details about how the device was used. The posted primary measure concerns the number of vertigo episodes experienced in the past month, assessed from baseline to 90 days.
Comparator
The comparison group received a device named Control Device. The official study title calls the trial placebo-controlled, and the registry lists both devices as interventions. It does not report enough detail to describe the control device's function or distinguish its use from that of the Mastoid Oscillator beyond the arm names.
Primary question
The primary question was whether the number of monthly vertigo episodes changed over the period from baseline to 90 days in participants assigned to the Mastoid Oscillator, compared with those assigned to the Control Device. The outcome is patient-reported and refers to episodes in the past month. The registry posts arm-level summaries but says values were missing or not estimable for a two-arm comparison of this rate endpoint. It therefore does not provide a formal estimate of the difference between assigned groups.
3. Trial Design
The registry identifies NCT03520322 as a prospective, randomized, blinded, placebo-controlled, single-center efficacy study of a mastoid device in subjects with Ménière's disease. Allocation was randomized, masking was listed as triple, and the design was parallel. The registry does not identify which people or roles were masked, or give further details about the randomization or masking procedures. The phase is listed as NA.
The two arms were Mastoid Oscillator and Control Device. Both are recorded as device interventions, and the arm descriptions identify participants in each as having Ménière's disease. The brief summary describes the intended population as patients with active disease not controlled by traditional medical management. The registry does not report additional eligibility criteria or the intended schedule of device use.
The study start date is 2019-01-29, and the primary completion date is 2024-02-14. Its status is TERMINATED. The reason for termination is not reported in the registry record. Enrollment is listed as 7. The primary-outcome summaries list 3 participants for each arm; the record does not explain why those group counts do not account for the full enrollment listing.
The primary outcome is titled Change in the Number of Monthly Vertigo Episodes, with a timeframe of baseline to 90 days. Three secondary outcomes are listed: change in average pure tone threshold, change in percentage of words recognized, and change in Meniere's Functional Level. The registry does not report a statistical analysis plan, the intended enrollment rationale, or further design details that would explain how the study was expected to address its clinical question.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: One subject was consented but not randomized to the intervention.
Overall Study
| Stage | Mastoid Oscillator | Control Device |
|---|---|---|
| STARTED | 3 | 3 |
| COMPLETED | 3 | 3 |
| NOT COMPLETED | 0 | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Mastoid Oscillator | Control Device | Total |
|---|---|---|---|---|
| Participants analysed | 3 | 3 | 6 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 2 | 3 | 5 |
| Age, Categorical: >=65 years | Participants | 1 | 0 | 1 |
| Sex: Female, Male: Female | Participants | 2 | 1 | 3 |
| Sex: Female, Male: Male | Participants | 1 | 2 | 3 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 3 | 6 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): White | Participants | 3 | 3 | 6 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Region of Enrollment: United States | participants | 3 | 3 | 6 |
6. Primary Endpoint
The registry lists the primary outcome as Change in the Number of Monthly Vertigo Episodes, measured over Baseline to 90 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Episodes per month |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is a patient-reported measure of the number of vertigo episodes experienced in the past month. It is framed as change from baseline to 90 days and expressed in episodes per month. Counting episodes focuses on a symptom that is directly relevant to the study's stated question about Ménière's disease, while asking about the past month defines the recall period for each report.
In general, measuring change over time can describe whether an outcome differs from a participant's starting point. A comparison between randomized groups is needed to distinguish a difference associated with assignment from changes that may occur over time in either group. The registry record provides arm-level mean and standard deviation summaries, but reports that a two-arm comparison was not estimable for this rate endpoint because values were missing or not estimable.
The posted summaries therefore do not establish a comparative change from baseline. The record does not provide a confidence interval or a formal test for the difference between arms, and it does not report individual-level measurements or additional detail about how the monthly episode counts were collected at each assessment.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry posts a primary-outcome mean of 20.8 episodes per month for the Mastoid Oscillator arm and 22.2 episodes per month for the Control Device arm. Each arm's summary is based on 3 participants. The reported standard deviations are 26.0 and 4.8, respectively. These are descriptive arm-level summaries; the record does not provide a formal estimate of the difference between groups.
The outcome is described as change from baseline to 90 days, but the posted arm summaries alone do not show how each participant's value changed or how the groups differed in change. The registry explicitly notes that values were missing or not estimable for a two-arm comparison of the rate endpoint. Consequently, the means should not be treated as a treatment-effect estimate, and they do not answer the comparative primary question on their own.
The standard deviations describe variability among the observations contributing to each arm's summary. The difference in the reported spreads is notable descriptively, but with only 3 participants represented in each arm, these summaries offer limited information about the full variability that might occur in the study population. They also do not indicate why participants' measurements varied. No confidence interval is posted, so the precision of an estimated arm contrast cannot be evaluated from the registry results.
The record lists 7 enrolled participants, while the primary outcome summaries list 3 in each arm. It does not explain the relationship between overall enrollment and the numbers contributing to this endpoint. Nor does it report whether endpoint data were unavailable for particular participants, how missing observations were handled, or which analysis population was intended. Those omissions limit interpretation of both the summaries and the absent comparison.
No analysis results are listed, and no p-value or adjusted estimate is reported. The registry also lists three secondary outcomes, but numerical results for them are not reported in the registry record. Accordingly, the available outcome information is confined to these primary-outcome arm summaries and the stated reason a two-arm comparison could not be estimated. Neither the descriptive means nor the absence of a comparative analysis can establish that the devices differ or are equivalent.
9. Statistical Methods Explained
The registry identifies the primary measure as a mean, with standard deviation as its measure of dispersion, and gives episodes per month as the unit. It also categorizes the endpoint as a rate, meaning an event count per unit of exposure. The posted arm summaries are 20.8 for the Mastoid Oscillator and 22.2 for the Control Device, with standard deviations of 26.0 and 4.8. Each arm summary has 3 participants. The registry says values were missing or not estimable for a two-arm comparison of this rate endpoint.
What does a mean describe?
In general, a mean gives a central summary of observed values in a group. It can be useful for describing the typical level of a measured outcome, but it does not reveal the range or distribution of individual observations. The registry's means summarize the endpoint by arm; they do not, by themselves, quantify the effect of assignment to one device rather than the other. A comparative estimate would need to be calculated using a defined analysis and the relevant participant-level or summary information.
What does a standard deviation describe?
In general, a standard deviation describes how dispersed observations are around their mean. A larger standard deviation indicates more observed spread in that group, while a smaller one indicates less spread in the observed data. It is not the same as a confidence interval and does not directly describe uncertainty about the difference between groups. Here, the reported standard deviations are 26.0 and 4.8. The groups each have only 3 participants in the outcome summaries, so the observed spreads are based on very few observations and may not characterize variability well beyond those participants.
Why is a rate endpoint different?
In general, a rate relates the number of events to an amount of exposure, such as time at risk or time under observation. Comparing rates ordinarily requires information that supports the event count and its exposure denominator, together with a specified statistical model or method. A mean count in episodes per month does not automatically supply all information needed to estimate a comparative rate. The registry's note that a two-arm comparison was not estimable is therefore important: it signals that the posted summaries should not be used to construct an unsupported rate contrast.
What can randomization contribute?
In general, random allocation is intended to make assigned groups comparable with respect to characteristics that could affect outcomes, particularly when the study is adequately implemented and includes enough participants. It does not guarantee that groups will be similar in a small trial, and it cannot remedy missing endpoint information or replace a reported analysis. The registry identifies randomized allocation but does not report the allocation procedure, a statistical plan, or a formal group comparison.
How should uncertainty be assessed?
In general, a confidence interval gives a range of values compatible with the data and the assumptions of the analysis. Its width communicates the precision of the estimate: a wider interval indicates greater uncertainty. A formal test addresses a related question through a p-value, but neither a p-value nor an interval substitutes for an effect estimate and an understanding of the endpoint. The registry does not report a comparative confidence interval, a p-value, or an estimable two-arm result for this primary outcome. Precision about the between-arm effect therefore cannot be judged from the posted arm means and standard deviations alone.
What do planning calculations mean?
In general, a sample-size calculation is a planning exercise based on an assumed effect, variability, statistical method, and error rate. It is distinct from the observed result and does not show that a completed trial had a particular probability of detecting an effect. Any planning illustrations based on an observed effect are especially dependent on the stability of that estimate; they are not evidence of an effect and are not the trial's original design rationale. The registry record does not report the trial's own sample-size justification or a numerical planning result. It also does not report an interim analysis plan or other details needed to describe planned monitoring of efficacy data.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary outcome and three secondary outcomes: change in average pure tone threshold, change in percentage of words recognized, and change in Meniere's Functional Level. It does not report numerical results for those secondary outcomes. The record lists no analyses, and does not report a plan for controlling the chance of false-positive findings when more than one outcome is examined. Without a stated multiplicity strategy or reported analyses, the role of the secondary outcomes in drawing conclusions cannot be assessed.
The registry's reason for not presenting a two-arm comparison is that values were missing or not estimable for the rate endpoint. It does not specify which values were unavailable, why they were unavailable, or how missing data were handled. The overall enrollment is 7, while the primary-outcome summaries include 3 participants in each arm. The record does not explain the difference, identify an analysis population, or describe whether the outcome summaries include all randomized participants.
In general, missing outcome data can affect both the precision and interpretation of a comparison, especially when the reasons for missingness differ across participants or groups. An analysis-population definition and a clear missing-data approach help readers understand which participants contributed and what assumptions support the results. Those details are not reported in the registry record, so it is not possible to determine how missing observations relate to the posted summaries or to reconstruct an analysis of the primary question.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Mastoid Oscillator | 0 | 3 | 0.0% |
| Control Device | 0 | 3 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Mastoid Oscillator | 0 of 3 |
| Control Device | 0 of 3 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Mastoid Oscillator | 0 of 3 |
| Control Device | 0 of 3 |
The registry reports serious adverse event counts for each arm. For the Mastoid Oscillator arm, 3 participants were listed as at risk and 0 were reported as affected by a serious adverse event. For the Control Device arm, 3 were listed as at risk and 0 were reported as affected. Deaths are listed as 0 in each arm. No serious adverse event terms are listed.
These are counts from the registry record, not estimates of comparative safety. With 3 participants listed at risk in each arm, the absence of a reported serious adverse event in these summaries does not establish that such events cannot occur or that the arms have the same safety profile. The record also lists 0 participants affected by other adverse events in each arm, with 3 at risk per arm.
In general, adverse-event counts are interpreted in light of the number of participants observed, the duration and completeness of follow-up, and the way events were collected and classified. The registry does not provide further details about those aspects or list event terms. These figures should therefore be read narrowly as the counts posted for this study, rather than as a complete characterization of risk.
12. What the Result Does, and Does Not, Mean
The available record documents a randomized, triple-masked, parallel study of a Mastoid Oscillator and a Control Device, with a primary endpoint concerning monthly vertigo episodes from baseline to 90 days. It reports mean values of 20.8 and 22.2 episodes per month, with standard deviations of 26.0 and 4.8, respectively. Each arm's outcome summary includes 3 participants. The record does not report an estimable two-arm comparison for this rate endpoint.
These descriptive values do not establish how much the outcome changed from baseline in either arm, nor do they quantify a difference in change between arms. The absence of a comparative estimate, confidence interval, and formal test means that the direction and precision of a group-level effect cannot be assessed from the posted primary-outcome information. The small numbers represented in the arm summaries also limit how much can be inferred about variability beyond the observed participants.
The record does not report numerical results for the listed secondary outcomes, explain the relationship between 7 enrolled participants and the 3 participants summarized in each arm, or specify a missing-data approach. It also does not give the reason the study was terminated. Those gaps leave important questions about outcome availability and analysis unresolved.
In general, a registry record can describe a study's design and post outcome summaries, but interpretation depends on the completeness of the results and the methods used to compare groups. The information supports a description of the trial and its posted arm-level primary-outcome summaries. It does not establish whether the devices differ, whether they are equivalent, or what the findings mean for an individual patient.
13. Why This Trial Matters Statistically
This trial is statistically notable because its registry record combines randomized allocation with very limited outcome summaries. Randomization is an important design feature for comparative research, but an interpretable estimate still depends on outcome data and a defined analysis. In this record, the primary endpoint is described, and arm-level means and standard deviations are posted, yet the registry says a two-arm comparison of the rate endpoint was not estimable.
The discrepancy between the overall enrollment listing of 7 and the endpoint summaries of 3 participants per arm is also consequential for statistical interpretation. The record does not explain which participants contributed data or why the group summaries account for fewer people than the enrollment count. Without that context, readers cannot determine whether the reported summaries represent all participants with relevant data or a selected subset.
The outcome is a monthly count of vertigo episodes, categorized as a rate. In general, rate analyses must account for the event count and relevant exposure information. The posted summaries do not enable a comparative rate estimate, and the registry explicitly notes that the comparison was not estimable. This is a useful distinction between seeing group summaries and having evidence about a between-group effect.
Finally, the listed secondary outcomes have no numerical results in the registry record, and no analyses are listed. The study therefore illustrates why design labels and descriptive statistics cannot substitute for a complete report of comparative estimates, their uncertainty, analysis populations, and missing-data handling. Its statistical importance lies in making those limits visible, rather than in supporting a conclusion about the devices.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The primary endpoint is described as change from baseline to 90 days, but the registry does not provide details about the values at each assessment or how change was calculated. It posts arm-level mean and standard deviation summaries, yet says values were missing or not estimable for a two-arm comparison of the rate endpoint. No comparative estimate or confidence interval is reported, limiting assessment of the size and precision of any group difference.
Only 3 participants per arm are included in the primary-outcome summaries, while overall enrollment is listed as 7. The registry does not explain this discrepancy, identify which participants contributed to the outcome summaries, or describe missing observations. The analysis population and missing-data methods are not reported. The reason for termination is also not reported in the registry record.
The registry lists three secondary outcomes but does not report their numerical results. It does not report the statistical analysis plan, a sample-size justification, an interim analysis plan, or a strategy for addressing multiplicity. The single-center design is stated in the official title, but further information about recruitment, eligibility, follow-up, measurement procedures, and device use is not reported in the registry record. These limitations constrain interpretation of both the posted summaries and the study's broader evidential scope.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of a Mastoid Device in Subjects With Ménière's Disease — NCT03520322.
- Registry record last updated 2024-12-12; status last verified 2024-12.
- Results first posted 2024-12-12.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT03520322 is a randomized, triple-masked, parallel, single-center study of a Mastoid Oscillator versus a Control Device in people with Ménière's disease. The registry lists enrollment of 7, a start date of 2019-01-29, a primary completion date of 2024-02-14, and status TERMINATED. The reason for termination is not reported in the registry record.
The primary endpoint concerns change in monthly vertigo episodes from baseline to 90 days. The arm summaries report means of 20.8 and 22.2 episodes per month, with standard deviations of 26.0 and 4.8, and 3 participants per arm. The record states that values were missing or not estimable for a two-arm comparison of this rate endpoint. Three secondary outcomes are listed, but their results are not reported in the registry record. No analyses are listed.