Eustachian Tube Dysfunction Assessment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Eustachian Tube Dysfunction Assessment (NCT02667301), a na na study. The primary outcome is Latency Between mLVP and mTVP Signals.

2. Clinical Question

In practical terms, this is a physiological measurement question rather than a treatment-effect question. The registry describes observations intended to characterize muscle activity and tympanic air exchange. It does not specify a treatment assignment, randomized contrast, or clinical outcome comparison. The proposed relationship between muscle timing and tube opening is therefore the subject of measurement, not a result that can be confirmed from the posted numerical data. Details such as the operational definition of functional Eustachian tube status, the recruitment setting, and the criteria used to classify dysfunction are not reported in the registry record.

3. Trial Design

The registry describes a completed, single-group study with enrollment of 55. Allocation is recorded as NA, and masking is recorded as NONE. The study is not a randomized comparison; its arm description names EMG, TAS and tympanometry rather than separate treatment and control groups. The record lists Eustachian Tube Dysfunction as the condition and identifies the study purpose as understanding paratubal muscle activity in patients with functional Eustachian tubes and those with Eustachian tube dysfunction.

The recorded procedures are EMG recording, the Tympanic Cavity Air Exchange Test, and a tympanometer test. The arm description says that the same group of professionals performed the work. It identifies an ENT specialist with 30+ year experience for EMG needle administration, a neurologist with 20+ year experience for EMG recording, and an experienced technician for TAS recording. The description is incomplete, so other details about the procedures and their sequence are not reported in the registry record.

The primary endpoint timeframe is stated as a test conducted within 60 days after enrolling the patient. The start is recorded as 2014-01, primary completion as 2015-11, and status as COMPLETED. The study phase is NA. A protocol-level schedule, planned follow-up beyond the stated endpoint timeframe, and full eligibility criteria are not reported in the registry record.

The design is suited to descriptive physiological observations, but the record does not establish a randomized basis for comparing patients with functional tubes against patients with dysfunction. It also does not describe an allocation method, blinded assessment, or a prespecified comparison between those groups. The reported enrollment should not be interpreted as the denominator for every endpoint or safety measure: the posted serious and other adverse-event counts list 16 at risk in each category, and the reason for that denominator is not reported.

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: 39 enrolled participants were excluded from the study before assignment to the group because of unreliable EMG records generating wrong electrode placement for Tensor Veli Palatini and Levator Veli Palatini muscles in the soft palate.

Overall Study

Reasons for not completing this period:

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.

6. Primary Endpoint

The registry lists the primary outcome as Latency Between mLVP and mTVP Signals, measured over Test is conducted within 60 days after enrolling the patient.

The primary endpoint is titled Latency Between mLVP and mTVP Signals. It measures the time difference between the mLVP and mTVP signals in milliseconds. The registry describes this timing difference as an indication of synchronization of muscle activities. The reported summary type is the mean, with standard deviation as the stated measure of dispersion.

The rationale is mechanistic: if the activities of the recorded muscles are synchronized in a particular way, their timing may help characterize the process associated with Eustachian tube opening. This makes latency a measure of physiological timing, not a direct measure of symptom improvement or treatment benefit. The endpoint alone cannot establish that a tube opened successfully, explain why a participant had dysfunction, or show that one group differed from another.

Some measurement details needed for a fuller interpretation are not reported in the registry record. These include whether the time difference is signed or absolute, how signal onset was defined, how unusable or ambiguous signals were handled, and whether measurements were repeated. The population field for the primary endpoint is blank. A numerical mean, standard deviation, confidence interval, and group-specific result are not reported in the registry record, so the magnitude and precision of the latency cannot be described from the posted results.

In general, a mean describes the central value of a continuous measurement, while a standard deviation describes how spread out participant measurements are around that mean. Neither statistic, by itself, conveys uncertainty in the estimated mean as fully as an appropriate confidence interval would. No confidence interval for this endpoint is reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a continuous timing measure, summarized in the registry as a mean with standard deviation. The endpoint is the time difference between mLVP and mTVP signals, in milliseconds, and is intended to indicate synchronization of muscle activities. The registry record does not provide the numerical mean or standard deviation, nor does it identify an analysis method used to estimate or compare values.

What does the mean describe?

In general, the arithmetic mean combines measurements into a central summary. For a physiological timing measure, it can provide a compact description of the observed latency, but it may be affected by unusually large or small values. A mean is most interpretable alongside the distribution of the measurements and a clear definition of the analysis population. Here, the distribution, participant-level measurements, and primary analysis population are not reported in the registry record.

What does the standard deviation describe?

In general, a standard deviation describes dispersion among observations around the mean. It is not the same as the uncertainty of the mean: uncertainty also depends on the amount of usable information and the analysis design. A small standard deviation does not automatically imply a precise estimate, and a larger one does not by itself establish that groups differ. The registry names standard deviation as the endpoint's dispersion measure but does not report its value.

Why does the design matter?

The study is listed as single group, with no random allocation and no masking. That structure is important when interpreting statistical comparisons. A group contrast would require a clear definition of the groups, an analysis population, and a method for handling differences in participant characteristics or measurement conditions. The record's purpose mentions people with functional Eustachian tubes and people with dysfunction, but the outcome population is blank and no group-specific results are reported. A randomized treatment comparison should not be inferred from this design.

In general, observational contrasts can be influenced by factors associated both with group membership and with the measured outcome. Statistical adjustment can sometimes address measured factors, but it cannot guarantee removal of bias, especially when important factors are unmeasured or poorly recorded. The registry does not report an adjusted analysis, a covariate set, or a statistical model. It is therefore not possible to determine whether any reported contrast was adjusted; in fact, a numerical contrast is not reported.

How should uncertainty be read?

In general, a confidence interval expresses uncertainty around an estimate under a specified statistical model and sampling framework. Its width reflects both the variability of observations and the amount of information used. A confidence interval is not reported for the primary endpoint. Neither a p-value nor a test statistic is reported, and no analyses are listed in the registry record. Without these results, readers cannot assess statistical compatibility with a null hypothesis or the precision of a possible group difference.

Statistical significance and scientific importance are separate questions in general. A small p-value, if one were reported, would not by itself establish that an effect is large, clinically meaningful, or causal. Conversely, an imprecise estimate would not establish absence of a relationship. In this record, the absence of a reported estimate means neither the magnitude nor the uncertainty can be assessed.

What do the planning illustrations mean?

In general, sample-size calculations describe how many observations might be needed under specified assumptions to detect a chosen effect with a chosen error rate and power. The record labels its planning calculations as illustrations based on the observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. These calculations are not the trial's own design justification. The assumptions of two arms and equal allocation do not match the listed single-group design, and no protocol-based sample-size justification is reported. Such illustrations are planning aids, not observed power and not evidence that a study did or did not detect an effect.

In general, a continuous outcome can also be affected by skewness, outliers, repeated measurements, or measurement error. Alternative summaries or models may be appropriate in some circumstances, but the right choice depends on the data and protocol. The registry record does not report the latency distribution, rules for signal quality, repeated-measure structure, or diagnostics. It also does not report whether the analysis used all recorded observations or a subset. No additional statistical method should be attributed to the investigators from the information available.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("EMG, TAS and Tympanometry")
n   <- c(16)
m   <- c(127.26)
sp  <- c(61.028420946845)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  EMG, TAS and Tympanometry  16  127.260  61.028  94.740  159.780

11. Multiplicity, Missing Data and Analysis Populations

The registry lists three outcome measures and identifies latency between mLVP and mTVP signals as the primary endpoint. It also lists a secondary outcome concerning amplitude in mTVP and mLVP in microvolts. The record does not provide the full details of all outcome measures or their results. A prespecified hierarchy, multiplicity adjustment, or plan for interpreting multiple outcomes is not reported in the registry record.

In general, testing several outcomes can increase the chance of obtaining an apparently unusual result by chance if each is treated as a separate confirmatory test. A prespecified strategy can clarify which outcome is primary and whether secondary analyses are exploratory or adjusted. The registry identifies a primary endpoint, but does not describe a family-wise error approach, adjustment method, or interpretation plan. Since no inferential results are posted, the impact of multiplicity on conclusions cannot be evaluated.

Missing-data handling is also not reported. The record does not say how participants with absent, incomplete, or unusable EMG or air-exchange measurements were handled, whether reasons for missingness were recorded, or whether any imputation or sensitivity analysis was performed. The primary endpoint population field is blank. These omissions matter because the number and characteristics of participants with usable measurements can affect both the estimated mean and its uncertainty.

The record lists enrollment of 55, but gives an at-risk count of 16 for each adverse-event category. It does not explain whether the smaller denominators reflect a subset, a particular follow-up period, or another reporting convention. The number contributing to the primary endpoint is not reported. An analysis population definition—such as all enrolled participants or those with evaluable measurements—is not reported either. No assumptions about missingness or participant inclusion should be inferred from the enrollment figure alone.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent non-serious adverse event terms

The registry lists a single group titled EMG, TAS and Tympanometry. For serious adverse events, 16 participants are listed as at risk and 0 as affected. For other adverse events, 16 are listed as at risk and 1 as affected. The record does not identify the event term for the other adverse event, and no top serious-event terms are listed.

The death count is null in the registry record. That is not the same as a reported count of zero; the number of deaths is not reported in the registry record. The time period and event-collection procedures are also not described in the available safety information.

The at-risk count of 16 should be read as the denominator recorded for these safety categories, not as the total enrollment of 55. The reason that the safety denominator differs from enrollment is not reported. Without that explanation, these counts should not be converted into a whole-study risk estimate or treated as evidence that every enrolled participant was monitored for the same duration.

In general, adverse-event counts describe events recorded under a study's collection and reporting procedures. They do not by themselves establish that an event was caused by a study procedure. The registry record does not report attribution, event timing, severity details for the non-serious event, or the extent of follow-up. The available figures therefore describe only the posted counts and their listed denominators.

13. What the Result Does, and Does Not, Mean

The record describes a study designed to observe paratubal muscle activity and tympanic air exchange in relation to Eustachian tube opening. Its primary measure is the timing difference between mLVP and mTVP signals, summarized as a mean and standard deviation. These details identify the physiological question and the kind of measurement the investigators intended to characterize.

However, a study aim is not an outcome finding. The registry does not report a numerical primary-endpoint result, a group-specific estimate, or a statistical comparison. It therefore does not establish the size or direction of the signal latency, how variable it was, or how precisely it was estimated. The listed purpose includes people with functional Eustachian tubes and people with dysfunction, but the record does not report their separate results.

The design is single group, with no random allocation or masking. This is not a randomized comparison of treatments, and the listed procedures are measurement activities rather than a treatment contrast. Consequently, the record does not establish that an intervention caused a change in muscle activity, tube opening, symptoms, or any clinical outcome. It also does not show whether latency distinguishes functional tubes from dysfunction.

In general, a physiological association can help describe a mechanism, but an association alone does not establish causation. A strong mechanistic interpretation would depend on clear measurement definitions, adequate and relevant observations, a suitable comparison, and transparent analysis. The registry does not provide enough detail to assess several of those elements, including signal-processing rules, endpoint analysis population, missing-data handling, and any adjustment for participant characteristics.

The posted safety figures record 0 serious adverse events among 16 at risk and 1 other adverse event among 16 at risk. The record does not explain why those denominators are smaller than enrollment, identify the non-serious event, or report the death count as a number. These data should be understood as limited registry counts, not a complete characterization of safety.

Overall, the record offers a description of the intended physiological assessment and some procedural details, but not the numerical primary result needed to judge the observed timing pattern. It supports neither a claim of benefit nor a claim of no effect. The absence of a reported estimate is a reporting limitation, not evidence that the underlying biological relationship is absent.

14. Why This Trial Matters Statistically

This study is statistically interesting because it frames a clinical problem as a question about measurable physiological timing. The endpoint connects EMG signals from mLVP and mTVP with a stated concept—synchronization of muscle activities—and the study also includes tympanic air-exchange and tympanometry procedures. That combination illustrates how clinical measurement studies can define a mechanistic question without testing a treatment.

The record also illustrates why design labels matter. A single-group study can describe measurements in the observed participants, but it does not automatically provide a controlled comparison. The study purpose refers to functional Eustachian tubes and dysfunction, yet no group allocation, group sizes, or group-specific endpoint estimates are reported. Without those details, the proposed contrast cannot be evaluated statistically.

Another important issue is the distinction between enrollment and analysis denominators. Enrollment is listed as 55, whereas the safety categories list 16 at risk. The record does not explain this difference, and the primary endpoint population is blank. Statistical interpretation depends on knowing which participants contributed data and why others might not have contributed. Clear denominator reporting is therefore essential, even when the scientific question is primarily physiological.

In general, a well-defined endpoint does not guarantee that the result will be interpretable. Readers also need the observed estimate, variability, analysis population, uncertainty, and transparent handling of missing observations. Here, the endpoint and its intended meaning are described, but its numerical result is not reported. The gap between a specified outcome and a posted estimate is a useful reminder that registration details and results reporting serve different purposes.

The registry also identifies planning illustrations based on assumptions that describe two arms and equal allocation, while the listed study design is single group. This contrast underlines why planning calculations must be interpreted in the context of the actual design. A hypothetical calculation is not a description of the study's realized analysis or evidence of power. The registry's own sample-size justification is not reported.

15. 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 limitation for interpretation is that no numerical result for the primary endpoint is reported in the registry record. Without the mean latency, standard deviation, and an uncertainty estimate, readers cannot assess the observed timing or its precision. No group-specific estimates or formal comparisons are reported either, despite the study purpose referring to functional and dysfunctional Eustachian tubes.

The registry does not report full eligibility criteria, the basis for classifying functional status, or how many participants were in each clinical group. The population field for the primary endpoint is blank. It is therefore unclear which enrolled participants were intended to contribute to the primary analysis, and whether all participants had measurements that could be used.

Measurement details are incomplete. The record does not define signal onset, clarify whether latency is signed or absolute, describe how low-quality signals were handled, or specify whether observations were repeated. The arm description is truncated after describing the professionals involved. These omissions limit assessment of measurement reproducibility and the meaning of the endpoint.

The study is single group, allocation is NA, and masking is NONE. No like-for-like control comparison is identified. This limits the ability to attribute any observed pattern to a specific cause or to distinguish group differences from other participant or measurement characteristics. The registry does not report an adjustment strategy or statistical model.

Missing-data procedures, analysis populations, multiplicity handling, and a protocol-based sample-size justification are not reported. Safety denominators are listed as 16 at risk for each category despite enrollment of 55, with no explanation. The non-serious event is not identified, and the death count is not reported as a number. These are specific reporting gaps that constrain interpretation of the posted record; they do not establish what the unreported results or procedures were.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Eustachian Tube Dysfunction Assessment — NCT02667301.
• Registry record last updated 2021-04-20; status last verified 2021-04.
• Results first posted 2021-04-20.
• 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.

19. Record Summary

NCT02667301 is a completed, single-group study titled Eustachian Tube Dysfunction Assessment. Enrollment is recorded as 55. The stated purpose is to investigate paratubal muscle activity in patients with functional Eustachian tubes and those with Eustachian tube dysfunction. The listed procedures are EMG recording, Tympanic Cavity Air Exchange Test, and tympanometry.

The primary endpoint is the latency between mLVP and mTVP signals, in milliseconds, summarized as a mean with standard deviation. The stated timeframe is within 60 days after enrolling the patient. The registry does not report a numerical primary-endpoint result, group-specific estimates, or an inferential analysis. Allocation is NA and masking is NONE.

The safety record lists 0 serious adverse events and 1 other adverse event among 16 at risk in each category. The death count and the reason for the safety denominators are not reported. Full analysis populations, missing-data procedures, and the registry's own sample-size justification are not reported in the registry record.