Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion (NCT05821842), a randomized na study. The primary outcome is Primary Effectiveness.

2. Clinical Question

The registry describes the study aim as demonstrating the safety and effectiveness of Sonu for people with moderate to severe nasal congestion. The primary outcome is a continuous score, so the posted result summarizes mean change rather than the number of participants who crossed a threshold. A negative mean change indicates a lower score at follow-up than at baseline; because higher scores represent worse outcomes, that direction is consistent with reduced congestion scores on this scale.

The main statistical comparison of interest would be the difference in mean change between Sonu and sham. The registry record posts group-specific means and confidence intervals, but it does not post a two-group comparison for this continuous outcome. Therefore, the group summaries alone do not establish the size or statistical uncertainty of the between-group difference.

3. Trial Design

This is a randomized, double-masked, parallel-group study of Sonu versus a sham control. The registry lists enrollment as 52 and reports 26 participants in each group for the primary outcome. The study is marked completed. The sponsor is Third Wave Therapeutics, and the listed condition is nasal congestion and inflammations.

The Sonu group received acoustic resonance therapy using Sonu. The sham group received non-resonant acoustic energy using Sonu. Both procedures were described as lasting 15 minutes, twice a day, for two weeks. The primary outcome timeframe was 2 weeks. The registry does not explain which people were masked, how masking was maintained, or whether masking was assessed.

Random allocation is intended, in general, to make treatment groups comparable at the point of assignment, while masking can reduce some influences of expectations on treatment and outcome assessment. These are general design purposes, not evidence that every potential source of bias was eliminated in this study. The record does not report the randomization sequence method, allocation concealment, or further operational details.

The registry lists the primary outcome as Primary Effectiveness and names one secondary outcome as Secondary Effectiveness. It reports two outcome measures and no posted outcome analyses. A sample-size justification, prespecified statistical plan, interim analysis plan, and details of the analysis populations are not reported in the registry record. The enrollment figure is not, by itself, evidence that the study had a particular level of statistical power.

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.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Adults (18 years of age or and older) suffering from moderate to severe nasal congestion from rhinitis

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 Primary Effectiveness, measured over 2 weeks.

The primary endpoint is change from baseline in the nasal congestion sub-score at 2 weeks. The score ranges from 0 to 3; 0 is the minimum, 3 is the maximum, and higher scores mean worse outcomes. The registry reports this as a continuous measure and gives a mean change for each group with a 95% confidence interval.

Change from baseline expresses how the score at follow-up differs from the starting score. A negative change is a decrease in the score, which is in the direction of less severe congestion on the registry’s scale. The group means describe average change; they do not show how much individual participants varied or how many experienced a particular degree of change. The registry does not report the distribution of individual changes or a threshold for a clinically meaningful change.

In general, a continuous score can retain more gradation than a simple yes-or-no outcome, allowing the analysis to describe the average amount of change. Its interpretation depends on the scale’s meaning, the timing of measurement, and the quality and completeness of observations. Here, the defined timeframe is 2 weeks. Other measurement details, including the instrument’s validation and procedures for handling missing scores, are not reported in the registry record.

The primary endpoint is relevant to the stated study aim because it measures nasal congestion over the treatment period. However, the group-specific mean changes are not themselves the comparative treatment effect. That effect would require a direct between-group estimate, with its uncertainty, which is not posted for this continuous endpoint.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

For a continuous endpoint, a mean summarizes the central value of the observations. In this study, the reported quantity is mean change from baseline in a score, rather than the mean score at a single time point. The negative group means indicate that, on average, follow-up scores were lower than baseline scores in both groups. Since the scale labels higher scores as worse, the direction corresponds to lower reported congestion scores. This is a description of the posted data, not a conclusion about a causal treatment effect.

What does a confidence interval describe?

In general, a confidence interval expresses the uncertainty associated with an estimated quantity under a statistical model and its assumptions. A narrower interval indicates greater precision for that particular estimate, while a wider interval indicates less precision. A confidence interval is not a range containing every participant’s response, nor does it show how many participants improved. The 95% confidence intervals in this record apply to the group-specific mean changes, not to a direct comparison between groups.

The Sonu group mean change is -0.87, with a 95% confidence interval from -1.11 to -0.62. The sham group mean change is -0.44, with a 95% confidence interval from -0.64 to -0.23. Those intervals describe uncertainty around their respective group means as reported. They cannot be treated as the confidence interval for the difference between groups. A direct contrast would account for uncertainty in both groups, and would require an appropriate estimate and its standard error or equivalent analysis output.

Why is the between-group estimate important?

In a randomized comparison, the key effectiveness contrast is generally the difference in outcomes between assigned groups, analyzed according to a prespecified method. A within-group change can reflect the treatment, the passage of time, other influences, and measurement variability. The sham group offers a comparator for interpreting changes over the same period, but the group means alone do not quantify the treatment-versus-sham contrast.

The registry record does not post a two-arm comparison for this continuous outcome. It also notes that values were missing or not estimable for a recalculated two-arm comparison. Consequently, no recalculated contrast or uncertainty interval is presented. Separate confidence intervals should not be compared informally to decide whether the groups differ; that approach does not provide a valid test or direct estimate of the randomized comparison.

What does the scale contribute?

The score runs from 0 to 3, with higher scores indicating worse outcomes. This direction makes the sign of the mean change interpretable: negative values reflect decreases in the recorded congestion sub-score. The numerical scale is bounded, so its possible values are limited. The registry does not describe the distribution of baseline scores, how often scores were at the limits, or whether assumptions for a mean-based analysis were checked. Such details matter when judging how well a mean and its confidence interval represent the observed data.

In general, analyses of continuous outcomes often rely on assumptions about the observations and the sampling distribution of the estimated mean. If data are strongly skewed, clustered, or otherwise depart from the assumptions of a chosen method, the estimated uncertainty may not be well calibrated. The registry record does not report diagnostic checks, transformations, robust methods, or other details that would clarify those issues for this endpoint.

What can sample-size planning show?

The planning illustration is described as using the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is described as a stated fraction of the observed effect. Such calculations are planning illustrations, not observed power and not a report of the trial’s original design justification. The registry record does not report the original sample-size justification or the effect assumed when the study was designed. A calculation based on an observed effect also depends on that estimate, which can be uncertain.

In general, a sample-size calculation describes how many participants per arm might be needed under specified assumptions to target a chosen power for a defined effect. It does not tell whether an effect was actually present, and it cannot replace a treatment-effect estimate with a confidence interval. The listed assumptions do not establish that the study’s actual analysis used the same approach.

How should the posted analysis record be read?

The registry lists no posted outcome analyses. It reports group means and confidence intervals for the primary result, but does not report a direct inferential comparison, a p-value, or an adjusted estimate. The statistical analysis plan, including model specification, covariate adjustment, and handling of repeated or missing measurements, is not reported in the registry record. Without those details, the results should be read as limited descriptive summaries rather than as a complete inferential analysis of the randomized contrast.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists Primary Effectiveness and one secondary outcome, Secondary Effectiveness. It reports two outcome measures, but no outcome analyses are posted. A multiplicity plan describing whether or how statistical testing across outcomes was controlled is not reported in the registry record. The order of the outcomes alone does not establish a testing hierarchy or an adjustment method.

Missing-data handling is also not reported in the registry record. The posted primary group figures do not explain whether all randomized participants contributed data, how incomplete follow-up was handled, or whether any observations were excluded. The analysis population—such as whether the analysis followed randomized assignment—is not reported. These omissions matter because missing outcomes or exclusions can affect both the estimated mean changes and their uncertainty.

The registry record does not state whether an intention-to-treat, per-protocol, or other analysis population was used. It also does not describe imputation, sensitivity analyses, or reasons for missing observations. No assumptions about these methods can be inferred from the group means and confidence intervals alone.

These limits do not prove that the study lacked procedures for multiplicity or missing data; they mean that those procedures are not reported in the registry record. The absence of posted analyses also prevents assessment of how the stated primary and secondary outcomes were analyzed together.

11. 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 0% reporting threshold.

For the Sonu Treatment Group, the registry reports 0 participants affected by serious adverse events, 0 affected by other adverse events, and 0 deaths; 26 participants are listed as at risk for each adverse-event category. For the Sham Control Group, the corresponding figures are also 0 affected, with 26 listed as at risk for each category, and 0 deaths. No serious adverse-event terms are listed.

These figures mean that the registry reports no affected participants in the listed categories for the groups and observation period represented in the record. They do not establish that no event could occur, and they cannot rule out uncommon events. The record does not report the safety observation period in further detail, event definitions, severity grading, relatedness assessments, or the method used to collect adverse events.

Zero reported events should not be interpreted as proof of safety. Safety estimates depend on how events were sought, defined, and recorded, as well as the amount and duration of observation. The registry figures are a limited description of reported events, not a complete assessment of all possible risks.

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

The posted primary outcome indicates that mean nasal congestion sub-scores decreased from baseline in both groups at 2 weeks. The mean change was -0.87 for Sonu and -0.44 for sham, with the stated group-specific 95% confidence intervals. Given the scale direction, both means are consistent with lower congestion scores at follow-up. These summaries describe average changes; they do not show individual response patterns.

The main question for a randomized trial is comparative: whether outcomes differed between assigned groups. A direct estimate of the between-group difference and its uncertainty are not reported for this continuous endpoint. Without that estimate, the posted results do not establish how much the groups differed or how precisely any difference was measured. The separate confidence intervals do not answer that question.

The results do not show that Sonu caused the observed changes, nor do they establish whether the change was clinically meaningful. The registry does not report a threshold for meaningful change, a direct comparative test, or further analysis details needed to assess those conclusions. The randomized, double-masked design is relevant context, but design labels alone do not resolve the limitations of the posted results.

The safety figures report zero affected participants in the listed adverse-event categories and zero deaths in both groups. They are not evidence that no risk exists, particularly because event-collection details and the safety observation period are not reported in the registry record.

Overall, the record supports a descriptive account of group mean changes and reported adverse events. It does not supply a complete statistical comparison of Sonu against sham for the primary continuous outcome. Any interpretation should keep that distinction between descriptive group summaries and a comparative treatment effect clear.

13. Why This Trial Matters Statistically

This study illustrates why the distinction between within-group change and a between-group treatment contrast matters. The posted primary values describe mean change from baseline separately for Sonu and sham. A randomized study’s central comparative question concerns how those changes differ between groups, not whether each group’s mean change is above or below baseline in isolation.

The record also demonstrates that confidence intervals have a target: the intervals posted describe group means. They are useful for understanding precision of those means, but they are not automatically intervals for the treatment contrast. A direct estimate with its own uncertainty is needed to assess the comparative result. That distinction is important for reading clinical trial summaries without overstating what separate arm-level statistics establish.

Another statistical consideration is the relationship between planning and evidence. The record describes sample-size planning illustrations based on an observed effect and specified assumptions. Such illustrations can help explore planning scenarios, but they are not observed power and do not replace the original design rationale or the trial’s outcome analysis. The original sample-size justification is not reported in the registry record.

Finally, the absence of posted analysis details limits assessment of multiplicity, missing data, analysis populations, and the method used to estimate uncertainty. These are not merely technical details: they help readers understand what data were analyzed and how robustly the study addressed its primary question. Clear reporting of the direct contrast and its analysis would be necessary for a fuller statistical interpretation.

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 most important limitation of the posted effectiveness results is the absence of a direct two-arm estimate for the primary continuous outcome. The registry gives a mean change and confidence interval for each group, but does not report a comparative estimate, its confidence interval, or a p-value. The record indicates that a recalculated two-arm comparison was missing or not estimable, so there is no recalculated contrast to interpret.

Additional analysis details are not reported in the registry record. These include the statistical model, any adjustment for baseline score or other variables, assumptions and diagnostic checks, the analysis population, and the handling of missing outcome data. The record does not explain which participants were masked or how the masking process worked.

The endpoint is a score on a 0-3 scale, but the registry does not report baseline distributions, individual-level changes, or a threshold for clinically meaningful change. The posted means therefore do not show the range of responses or how many participants experienced a change considered important. Further detail about outcome measurement and validation is not reported in the registry record.

For safety, the registry lists zero affected participants in the reported categories, but does not provide further details about event definitions, collection methods, relatedness, or the observation period. The original sample-size justification, multiplicity plan, and interim analysis plan are also not reported in the registry record. These gaps constrain interpretation without establishing that the procedures were absent from the conduct of the study.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Sonu Nasal Congestion Relief Study in Patients Suffering From Moderate to Severe Nasal Congestion — NCT05821842.
• Registry record last updated 2024-04-26; status last verified 2023-09.
• Results first posted 2024-04-26.
• 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.

18. Record Summary

The registry describes a completed, randomized, double-masked, parallel-group study of Sonu versus sham in adults with moderate to severe nasal congestion from rhinitis. The Sonu procedure used acoustic resonance therapy; the sham used non-resonant acoustic energy. Both were described as 15 minutes, twice a day, for two weeks.

The primary outcome was change from baseline in nasal congestion sub-score at 2 weeks on a 0-3 scale, where higher scores mean worse outcomes. Mean changes were -0.87 for Sonu and -0.44 for sham, with 95% confidence intervals of -1.11 to -0.62 and -0.64 to -0.23, respectively. A direct comparison of the groups is not reported.

The registry reports zero participants affected by serious or other adverse events and zero deaths in each group. Further statistical, missing-data, analysis-population, and safety-collection details are not reported in the registry record.