Posterior Nasal Nerve (PNN) Rhinitis Study: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Posterior Nasal Nerve (PNN) Rhinitis Study (NCT03727347), a na na study. The primary outcome is Change in Reflective Total Nasal Symptom Score (rTNSS).

2. Clinical Question

This is a within-group question: it describes how the measured symptom score changed over time among participants in the treatment group. It does not directly estimate how outcomes would compare with no procedure, another treatment, or a sham procedure. Without a concurrent control group, a change between baseline and follow-up cannot by itself distinguish an intervention effect from other possible explanations for change over time.

The registry identifies chronic rhinitis as the condition and describes the intervention as low-power radiofrequency energy applied to the posterior nasal nerve area. The primary measure is patient-reported, covering four nasal symptoms and asking about symptoms reflected or felt over the last 12 hours. The study’s primary question is therefore about change in reported symptom severity at the specified follow-up, not about a comparison between randomized treatment assignments.

3. Trial Design

The registry describes NCT03727347, titled Posterior Nasal Nerve (PNN) Rhinitis Study, as a completed study of the InSeca Stylus device in chronic rhinitis. Its official title describes clinical evaluation of low-power radiofrequency energy applied to the posterior nasal nerve area for symptomatic relief of chronic rhinitis. The listed enrollment is 50, and the intervention is a device.

The design is recorded as single-group, with allocation listed as not applicable and masking listed as none. The treatment group received low-power radiofrequency energy applied to the nasal cavity mucosa overlying the posterior nasal nerve region, specifically the posterior middle meatus and posterior inferior meatus. The registry does not describe a randomized comparator group. Accordingly, the primary endpoint uses a before-and-after comparison within the treatment group rather than a contrast between treatment arms.

The registry lists the study start as 2018-10-16, primary completion as 2020-02-01, and status as completed. The phase is listed as not applicable. These record details describe the registered study; they do not provide a numerical result for the primary endpoint.

The primary outcome is mean change in reflective Total Nasal Symptom Score from baseline to 12 weeks after the procedure. The registry states that the analyzed population excludes a subject who did not complete the 12-week questionnaire because of oversight. It does not report a detailed analysis plan, a sample-size justification, or how the missing questionnaire was handled beyond that exclusion.

This design can describe the course of the recorded symptom score in the treated group. Its single-group structure limits interpretation of that course as an effect attributable to the procedure, because the registry record does not provide a concurrent control comparison.

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: Three potential subjects failed to meet one or more of the inclusion/exclusion criteria.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight.

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 Change in Reflective Total Nasal Symptom Score (rTNSS), measured over Comparison of scores at Baseline and 12 weeks post procedure.

The primary endpoint is mean change in reflective Total Nasal Symptom Score (rTNSS) from baseline to 12 weeks after the study procedure. The registry defines the change as the 12-week score minus the baseline score, with negative values signifying improvement. The measure is recorded in units on a scale, and the planned summary is a mean with standard deviation.

The rTNSS is a patient self-reported questionnaire covering rhinitis, nasal congestion, nasal itching, and sneezing. Participants report symptoms reflected or felt over the last 12 hours. The total score ranges from 0 to 12; a higher score indicates greater symptom severity. A change score provides a way to describe whether the recorded symptom burden is higher or lower at follow-up than at baseline.

Patient-reported symptom measures are relevant when the target of interest is a person’s experience of symptoms. A mean change summarizes the average direction and size of change in the analyzed group, while the standard deviation describes how spread out individual change scores are around that mean. These summaries answer different questions: the mean concerns the group average, and the standard deviation concerns variability among participants.

The numerical mean change and its standard deviation are not reported in the registry record. Thus, the endpoint definition and direction can be interpreted, but the magnitude and precision of the observed change cannot be assessed from the reported endpoint information.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The main endpoint is continuous: it is a numeric score, and the registry specifies a mean as its summary measure. For a continuous outcome, the mean gives the arithmetic average across the observations included in the analysis. It can describe the central tendency of changes, but it does not show whether most individual changes were close to the mean or whether changes varied widely.

What does the standard deviation describe?

The standard deviation describes the spread of observations around their mean. For this endpoint, it would help characterize how much participant-level change scores varied within the analyzed group. It is not the same as the standard error, which describes the precision of an estimated mean. A standard deviation can be substantial even when a mean is estimated precisely in a sufficiently large sample, and a small standard deviation does not itself establish that a mean is estimated precisely.

The registry specifies a mean and standard deviation for the endpoint but does not report their numerical values. It also does not report a confidence interval for the mean change. Consequently, the usual statistical interpretation of the estimate’s size and precision cannot be completed from the registry record.

How should a change score be read?

The endpoint is defined as the follow-up score minus the baseline score. Under that convention, a negative value means the follow-up score is lower than the baseline score, which the registry labels as improvement. A positive value would mean the follow-up score is higher. The score itself reflects symptom severity, with higher total scores indicating more severe symptoms. These directions are important: the sign of a change score has meaning only when the subtraction order and score direction are known.

A mean change summarizes average within-person change when baseline and follow-up observations are paired for the analyzed participants. It is not the same quantity as the difference between two independent groups. Because this study is registered as single-group, the endpoint does not represent a randomized treatment contrast.

What would an interval estimate add?

In general, a confidence interval expresses uncertainty around an estimated quantity under the statistical method used. A narrower interval indicates greater precision than a wider interval, but precision is not the same as clinical importance. The interval’s interpretation also depends on the analysis and its assumptions. No confidence interval is reported for this primary endpoint in the registry record, so the precision of the mean change cannot be judged from that record.

A p-value, if reported, would address compatibility between the observed data and a specified statistical null model; it would not measure the size or importance of a change. No primary-endpoint p-value is reported in the registry record. The absence of a reported p-value is not evidence that a test was or was not performed.

Why does the study design matter?

A before-and-after comparison asks whether the measured score differs over time within the treated group. A randomized comparison instead uses outcome differences between groups assigned to different conditions to estimate a treatment contrast. Randomization can support a causal comparison by balancing factors in expectation, but this registry record describes no randomized control comparison. The reported design therefore supports a descriptive account of change, not a direct randomized estimate of the procedure’s effect relative to a control.

Masking is listed as none. In general, masking can reduce the influence of knowledge about treatment assignment on some aspects of measurement or reporting. For a patient-reported symptom score, participants’ awareness may be relevant to how responses are recorded. The registry field alone does not establish how any such influence affected this study.

What do the planning assumptions mean?

The planning description states that sample-size illustrations are based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It also says the effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not a report of the original design rationale. The registry record does not report the trial’s own sample-size justification.

In general, a planning calculation estimates how many participants per arm might be needed to detect a specified effect under stated assumptions and a selected power target. Such a calculation is not observed power and does not demonstrate that the trial had a particular probability of detecting an effect after its results were observed. The record’s planning description does not supply the numerical inputs or outputs in the endpoint information, so no planning estimate can be interpreted from it.

Normal approximations are methods that use a normal distribution to approximate the sampling behavior of a statistic under specified conditions. Whether such an approximation is suitable depends on the analysis and data. Equal allocation is an assumption for the described planning illustration; it does not change the registered single-group design of this study. The illustration’s two-arm assumptions should not be mistaken for evidence that the clinical study included two randomized arms.

What is not described?

The registry record does not report a detailed statistical analysis plan, a model for the continuous endpoint, an adjustment strategy, or diagnostics for the analysis. It does not report whether any interim analysis was planned or conducted. Those details cannot be inferred from the stated outcome summary type, the count of analyses, or the planning assumptions. More complete statistical reporting would be needed to assess model choices, assumptions, and the robustness of an estimate.

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("InSeca Stylus Treatment Group")
n   <- c(49)
m   <- c(-5.1)
sp  <- c(2.6)
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  InSeca Stylus Treatment Group  49  -5.100  2.600  -5.847  -4.353

11. Multiplicity, Missing Data and Analysis Populations

The registry lists six outcome measures and one analysis, but it does not report a multiplicity strategy. Multiple outcomes can raise the chance of obtaining at least one apparently unusual result when many hypotheses are tested. Statistical approaches can address that issue, but the appropriate interpretation depends on which outcomes were designated primary, which tests were conducted, and what adjustment was prespecified. The registry counts alone do not establish those details. No adjustment method or hierarchy of outcomes is reported in the registry record.

The record identifies change in rTNSS as the primary endpoint. It describes the analyzed population as excluding a subject who did not complete the 12-week rTNSS questionnaire because of oversight. It does not report a numerical endpoint analysis population, an imputation method, or a sensitivity analysis for the missing questionnaire. The stated exclusion is the available description of how that missing endpoint was handled; further procedures should not be assumed.

Missing outcome data can matter because an analysis based only on observed follow-up scores may represent participants with complete observations differently from those without them. The direction and size of any resulting bias depend on the missingness process and the unobserved score. Those cannot be determined from the fact of one incomplete questionnaire alone. The registry does not report information sufficient to assess whether the missing outcome was related to baseline symptoms, follow-up symptoms, or other factors.

The record also does not describe an intention-to-treat approach, a per-protocol approach, or additional analysis populations. It is therefore best to interpret the endpoint as described: an analysis that excludes the participant missing the 12-week questionnaire, with no further missing-data or population details reported.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 4% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: pneumonia (2.0%), acute cholecystitis (2.0%).

The registry reports safety figures for the InSeca Stylus Treatment Group. It lists 50 at risk for serious adverse events and 2 affected, alongside 50 at risk for other adverse events and 31 affected. Deaths are listed as 0. The listed serious adverse event terms are pneumonia and acute cholecystitis, each reported as 2.0%.

These figures are descriptive counts for the study group. They should not be read as a comparison with an untreated group or another intervention: the registered design is single-group and no like-for-like control comparison is described. The counts alone do not establish whether an event was caused by the device or procedure. They also do not describe the full clinical course, timing, duration, or resolution of each event.

The registry record does not provide further context for interpreting these safety figures, such as detailed event narratives or a comparative analysis. A count of zero deaths in the record should be read as the reported death count for this group, not as proof that all possible safety risks are absent. The listed figures characterize what is recorded, while the single-group design limits comparative safety interpretation.

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

The record establishes that the study evaluated low-power radiofrequency energy applied to the posterior nasal nerve area in people with chronic rhinitis, using change in rTNSS from baseline to 12 weeks as its primary endpoint. It also defines how to interpret the score: higher scores indicate greater symptom severity, and a negative change score is designated as improvement.

Those details do not reveal the numerical result. The mean change and standard deviation are not reported in the registry record, nor is a confidence interval or p-value for the primary endpoint. As a result, the magnitude, variability, and statistical precision of the endpoint cannot be assessed from the record. The endpoint description alone cannot support a conclusion about how much the group’s score changed.

Even if a within-group change estimate were available, the study’s single-group design would remain important. Change between baseline and follow-up can describe the group’s course, but without a concurrent randomized control it cannot show how that course compares with what would have happened under another condition. This limits causal interpretation of an observed change.

The record also identifies a missing 12-week questionnaire and says that the participant was excluded from the analyzed population. It does not report a sensitivity analysis or other details that would show how the missing outcome might affect the estimate. The safety counts likewise describe the treatment group without a comparative control.

Accordingly, the registry record is informative about the intervention, study structure, endpoint definition, and selected safety counts. It is not sufficient to quantify the primary outcome, establish its precision, or make a comparative estimate. These distinctions separate what the registered information documents from conclusions that would require numerical outcome reporting and a suitable comparison.

14. Why This Trial Matters Statistically

This study is statistically notable for the contrast between a clearly defined patient-reported endpoint and a design that supports only a within-group description. The rTNSS captures four nasal symptoms and has a stated direction: higher scores indicate more severe symptoms, while a negative baseline-to-follow-up change is designated as improvement. That explicit measurement definition makes the endpoint interpretable in principle.

At the same time, the record does not report the numerical mean change or its standard deviation. Without those values, readers cannot evaluate the observed average or the variation in participant changes. The absence of a reported confidence interval also leaves precision uncharacterized. Reporting an endpoint’s scale and direction is useful, but it is not a substitute for reporting the estimate and its uncertainty.

The single-group design is another central statistical feature. A before-and-after outcome can describe change over time, but does not provide the direct contrast that a randomized control group would offer. This distinction matters when moving from a descriptive statement about scores to a claim about what caused a change.

The record’s account of an excluded missing questionnaire and its limited multiplicity detail also illustrate why analysis populations and outcome-selection procedures matter. Readers need to know how missing outcomes and multiple analyses were handled to assess how an estimate should be interpreted. Here, the record identifies an exclusion and lists outcome and analysis counts, but does not provide further methods.

These features make the study a useful example of how endpoint definition, design, missing-data reporting, and numerical results jointly shape statistical interpretation. The registry contains meaningful structural information, while leaving key elements needed to evaluate the primary outcome unreported.

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 interpreting the clinical outcome is that the registry record does not report the numerical mean change in rTNSS or its standard deviation. It therefore does not show the size or variability of the primary endpoint. A confidence interval and p-value are also not reported, leaving statistical precision and any test result unavailable.

The study is registered as single-group, with no masking and no randomized comparison. Its baseline-to-12-week endpoint can describe change among treated participants, but it does not estimate a contrast against a concurrent control. The design therefore limits attribution of any change to the procedure. The registry does not report a sham or other comparison group.

The analyzed population excludes a subject who missed the 12-week questionnaire because of oversight. The record does not describe imputation, sensitivity analyses, or additional analysis populations. It is not possible to assess from the record whether the missing outcome could affect the result or how robust the analysis is to its exclusion.

The registry lists six outcome measures and one analysis but does not report a multiplicity strategy or a detailed statistical analysis plan. It also does not report a sample-size justification for the trial, interim analyses, or further model details. Planning assumptions described for sample-size illustrations should not be mistaken for the trial’s own design rationale.

Finally, the adverse-event counts are not comparative, and the record gives limited contextual detail for the listed serious event terms. These limitations do not establish that the study’s results are invalid; they define which conclusions can and cannot be assessed using the registry information.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Posterior Nasal Nerve (PNN) Rhinitis Study — NCT03727347.
• Registry record last updated 2021-06-16; status last verified 2020-09.
• Results first posted 2021-06-16.
• 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

NCT03727347 is a completed, single-group study of the InSeca Stylus device in chronic rhinitis. The device delivered low-power radiofrequency energy to the nasal cavity mucosa overlying the posterior nasal nerve area. The registry lists enrollment of 50, no masking, and no randomized comparison.

The primary endpoint was mean change in reflective Total Nasal Symptom Score from baseline to 12 weeks. Negative change was defined as improvement. The analyzed population excludes a subject who did not complete the 12-week questionnaire because of oversight. The numerical mean change and standard deviation are not reported in the registry record.

The registry lists 50 at risk and 2 affected for serious adverse events, 50 at risk and 31 affected for other adverse events, and 0 deaths. Pneumonia and acute cholecystitis are each listed at 2.0%. The record does not provide a comparative safety analysis or further primary-outcome statistics.