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 User Study of the Soniflow System for Nasal Congestion Relief (NCT04910139), a na na study. The primary outcome is Total Nasal Symptom Score.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04910139 |
| Phase | NA |
| Condition | Nasal Congestion |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 50 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Third Wave Therapeutics |
| Results posted | Yes |
2. Clinical Question
Population
Adult subjects with nasal congestion. The registry record lists an enrollment of 50. It does not report further eligibility details, such as how congestion was defined or whether participants had other relevant conditions.
Intervention
The Soniflow System, a device described as an acoustic vibrational headband paired with a smartphone app. The treatment arm is described as treatment using acoustic energy. The registry does not report additional details about how participants used the system.
Comparator
No control arm or like-for-like comparator is reported. This is a single-group study, with allocation listed as NA and masking listed as none. The results therefore cannot be read as a randomized comparison against an untreated, sham, or alternative-treatment group.
Primary question
The primary endpoint is the mean Total Nasal Symptom Score at 20 minutes. The registry describes the score as combining four nasal symptoms, with lower scores indicating a better outcome. However, the registry record does not report the observed mean, its confidence interval, a change from baseline, or an inferential analysis. The study record therefore identifies the outcome being assessed but does not establish what the score was or how it changed.
3. Trial Design
This is a completed, single-group device user study, registered as NCT04910139. The registry lists Third Wave Therapeutics as the sponsor and gives the condition as nasal congestion. The intervention is the Soniflow System, described as an acoustic vibrational headband paired with a smartphone app. The treatment arm is described as using acoustic energy.
The record lists enrollment as 50 and gives the study start as 2020-07-15 and primary completion as 2021-01-26. Its status is completed. The phase is listed as NA, allocation as NA, and masking as none. These entries do not describe a randomized, blinded comparison. The record does not report a control arm, so the design does not provide a like-for-like comparison with a group receiving another intervention or no intervention.
The primary outcome is the mean Total Nasal Symptom Score, assessed at 20 minutes. The registry also lists Visual Analog Scale measures for headache and facial pain as secondary outcomes. Although three outcome measures are reported, the registry lists no analyses. It does not describe an analysis population, participant flow, baseline assessment, or statistical model. Those omissions prevent a detailed reconstruction of how outcomes were collected and analyzed.
A single-group study can describe measurements recorded in participants who used the intervention, but without a comparison group it cannot separate any observed change from other possible explanations, such as natural symptom variation, expectations, or measurement effects. In this case, even the primary outcome result is not reported in the registry record. The design and endpoint are identifiable; the endpoint findings are not.
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
| Stage | Treatment |
|---|---|
| STARTED | 50 |
| COMPLETED | 50 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Adult subjects with nasal congestion
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.
Population: Adult subjects with nasal congestion
| Characteristic | Unit | Treatment |
|---|---|---|
| Participants analysed | 50 | |
| Age, Categorical: Age – <=18 years | Participants | 0 |
| Age, Categorical: Age – Between 18 and 65 years | Participants | 46 |
| Age, Categorical: Age – >=65 years | Participants | 4 |
| Sex: Female, Male: Female | Participants | 20 |
| Sex: Female, Male: Male | Participants | 30 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 46 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 1 |
| Region of Enrollment: United States | participants | 50 |
| Total Nasal Symptom Score | units on a scale | 4.1 (3.5 to 4.6) |
6. Primary Endpoint
The registry lists the primary outcome as Total Nasal Symptom Score, measured over 20 minutes.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | 95% Confidence Interval |
| Unit | score on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Total Nasal Symptom Score (TNSS), recorded as a mean at 20 minutes. The registry defines TNSS as the sum of ratings for rhinorrhea, nasal congestion, nasal itching, and sneezing. Each symptom is rated as none, mild, moderate, or severe, represented by scores from 0 to 3. The total can range from 0 to 12, and the registry states that a lower TNSS means a better outcome.
A combined symptom score is used to represent several related nasal complaints in one measure. That can make it easier to describe the overall symptom burden than presenting each symptom rating alone. It also means interpretation depends on the score’s construction: a total can reflect different combinations of symptom ratings, and the total does not show which individual symptom contributed most.
The specified assessment time is 20 minutes, so the endpoint concerns symptoms at that time point. The registry does not report whether a baseline TNSS was collected, whether the reported mean was intended as a post-treatment value or a change, or how missing symptom ratings were handled. It also does not report the observed mean or its stated 95% confidence interval. Thus the endpoint definition clarifies what was meant to be measured, but the posted record does not give the result needed to judge its magnitude or precision.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary endpoint and its assessment time, but does not report the endpoint’s observed value. It specifies a mean TNSS with a 95% confidence interval at 20 minutes, yet the mean and interval themselves are not reported in the registry record. No baseline value, change estimate, test statistic, or p-value is reported either. Consequently, there is no posted primary-outcome estimate to interpret for size, direction, or statistical uncertainty.
The absence of a reported result is different from a result showing no change. It does not establish that symptoms improved, worsened, or remained stable. It also does not establish whether an observed difference, if one was measured, would be large or small. The registry record lists zero analyses, which further limits what can be inferred from its posted results.
Even if a before-and-after TNSS estimate were available, the single-group design would constrain interpretation. A within-group change describes what happened over time among those assessed, but it does not by itself show that the intervention caused the change. Without a reported comparator, changes could also reflect symptom fluctuation, expectation, study participation, or other influences. These are general considerations for interpreting uncontrolled studies, not findings reported for these participants.
A confidence interval, when reported, communicates the precision of an estimated quantity under the analysis assumptions. A narrower interval generally indicates more precision than a wider interval, but it does not resolve design limitations or eliminate bias. Here, no interval limits are reported, so the precision of the mean cannot be evaluated. The registry’s stated endpoint and scale range do not substitute for an observed estimate.
The record does list secondary outcomes for headache and facial pain, but it does not report their results or analyses. Thus neither the primary nor the listed secondary outcomes support a conclusion about the pattern of symptoms in the study. The appropriate reading is limited: the registry documents a completed study, an intended outcome measure, a time point, and safety counts, while leaving the efficacy-related outcome findings not reported in the registry record.
9. Statistical Methods Explained
The statistical description in the registry is limited. It identifies a continuous primary outcome summarized as a mean, with dispersion described as a 95% confidence interval. It does not report an analysis method, an estimate, or an inferential result. The explanations below describe the general meaning of these statistical terms and the limits imposed by the available record.
What does a mean TNSS represent?
A mean is an arithmetic summary of the measured scores in the analysis population. For a continuous measure, it describes the center of the observed values in a way that retains the size of score differences. TNSS is constructed from ratings of four symptoms, with lower totals described as better. A mean alone does not describe how much participants’ scores varied, whether the distribution was symmetric, or whether some participants had substantially different experiences. Those features require additional summaries or individual-level data, which are not reported in the registry record.
The registry specifies a mean at 20 minutes. It does not clarify whether that mean is a follow-up score, a change from baseline, or another summary. Those are distinct quantities: a follow-up mean describes scores at the assessment, while a change measure requires a defined earlier measurement and a method for comparing measurements. The registry record does not report a baseline TNSS or a change estimate, so these interpretations cannot be distinguished.
How should a 95% confidence interval be understood?
In general, a confidence interval gives a range of values compatible with an estimate under the statistical model and its assumptions. Its width conveys precision: more narrow intervals indicate greater precision than wider intervals. The confidence level describes the behavior of the interval-generating procedure over repeated applications, rather than assigning a probability to the particular fixed parameter after the interval has been calculated. This general explanation does not imply that the registry’s interval can be assessed; its endpoints are not reported in the registry record.
An interval should be considered alongside the design and the quantity being estimated. A precise estimate of a single-group mean would still be a single-group estimate. It would not create a comparison group or establish that the intervention caused an outcome. Conversely, a wide interval would indicate uncertainty about the estimated quantity, but the record contains no interval with which to assess that uncertainty.
What can the design estimate?
For a single-group study, a descriptive analysis could summarize the measured scores among participants with available data. If measurements were taken at more than one time, an analysis could also describe within-person changes. The registry does not report that a baseline assessment was collected, nor does it report an analysis of change. It lists allocation as NA and masking as none, and it does not identify a comparator. Therefore, no between-group treatment contrast is available in the registry record.
General statistical comparisons rely on a clearly defined estimand: the quantity the analysis is intended to estimate, such as a mean at a particular time or a mean change. The record names a mean TNSS at 20 minutes, but leaves other analysis details unreported, including the handling of incomplete observations and the population included in the calculation. Without those details or the results, readers cannot assess whether the reported estimate, if one exists outside the record, corresponds to a particular analysis population or method.
What does the planning illustration mean?
The registry’s planning assumptions describe an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is defined as a stated fraction of the observed effect. Such calculations are planning illustrations, not results from participants and not observed power. They do not establish that the completed study was designed around those assumptions. The record explicitly distinguishes the illustration from the trial’s own design. Because the outcome estimate and the resulting planning values are not reported in the registry record, no specific planning quantity can be interpreted.
In general, a planning calculation depends on the assumed effect, variability, analysis, and design. If a hypothetical comparison assumes two arms, that assumption does not change the actual single-group design recorded for this study. The illustration should therefore not be treated as evidence of a randomized comparison or as a substitute for a prespecified sample-size justification. Such a justification is not reported in the registry record.
Why are the analysis details important?
Statistical methods determine how measurements are summarized, which participants contribute to an estimate, and how uncertainty is quantified. A complete interpretation would normally require the analysis population, treatment of missing data, definition of the primary estimand, and the actual estimate with its uncertainty. The registry lists no analyses, and those details are not reported in the registry record. General statistical concepts can explain what the planned measure means, but they cannot recover an unreported result or analysis.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists three outcome measures: the primary TNSS endpoint and secondary Visual Analog Scale measures for headache and facial pain. It does not report results or analyses for these outcomes. The record therefore does not show whether the outcomes were tested, how they were ordered for interpretation, or whether any adjustment for multiple comparisons was used. A multiplicity procedure is not reported in the registry record.
In general, examining multiple outcomes can increase the chance of finding an apparently unusual result when each is considered separately. Prespecified outcome hierarchies or multiplicity adjustments can address that issue, but the registry does not report whether such methods were planned or applied. Since there are no posted analyses, there is no basis for determining whether multiplicity affected interpretation in this study.
Missing-data handling is also not reported in the registry record. The enrollment entry does not indicate how many participants contributed to each endpoint, whether any outcome measurements were incomplete, or how incomplete records were treated. No analysis population is described. Without those details, the denominator behind a mean or confidence interval cannot be verified, and potential differences between participants with and without measured outcomes cannot be assessed.
The record does not report an intention-to-treat approach, a per-protocol approach, or another analysis population definition. These are not interchangeable: each defines which participants and observations contribute to an estimate. The registry also does not report whether any imputation, sensitivity analysis, or other missing-data method was used. These methods must not be assumed from the fact that the study is marked completed. The primary and secondary endpoint estimates, analysis populations, and missing-data procedures are not reported in the registry record.
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 |
|---|---|---|---|
| Treatment | 0 | 50 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Treatment | 0 of 50 |
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 |
|---|---|
| Treatment | 0 of 50 |
The registry lists 50 participants at risk in the treatment group for serious adverse events and records 0 affected. It also lists 50 at risk for other adverse events and records 0 affected. Deaths are recorded as 0. These are the safety counts posted for the treatment group.
These entries should be read as registry-reported counts, not as a complete account of every safety aspect of the study. The record does not report event descriptions, observation duration, severity details beyond the serious-event category, or how adverse events were collected. It also does not list serious-event terms. A count of 0 in the registry does not show what monitoring procedures were used or whether all potential events were captured.
Because the study has no reported comparator, these figures do not provide a comparative estimate of event risk. They describe only the recorded counts in the treatment group. They do not establish that an event is impossible or that the device has no safety risks. The available safety interpretation is limited to the counts and categories entered in the registry record; further details are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that a completed single-group study assessed the Soniflow System in adults with nasal congestion and identified TNSS at 20 minutes as its primary endpoint. It also defines the scale and records safety counts for the treatment group. These registry entries describe the study’s scope and the outcome it was intended to assess.
The record does not report the observed primary endpoint mean, its 95% confidence interval, a baseline score, or an estimate of change. Nor does it report analyses or results for the secondary headache and facial-pain measures. As a result, the posted data do not show whether the recorded symptoms changed, how large any change was, or how precisely an outcome was estimated. No conclusion about symptom benefit or lack of benefit follows from an unreported endpoint result.
The single-group design also limits causal interpretation. Without a like-for-like comparator, an observed change—if one were reported—could not by itself distinguish an intervention effect from other explanations. This is a general design limitation, not evidence that any particular alternative explanation occurred in this study. The absence of masking, recorded as none, is another design feature that readers should keep in mind when considering subjective symptom ratings; the record does not provide enough detail to quantify its influence.
The posted safety information records no serious adverse events, other adverse events, or deaths in the treatment group. Those counts do not establish the absence of all safety concerns, because the registry does not report event collection details or additional safety context.
In short, the study record describes what was to be measured and gives limited safety counts, but it does not provide the outcome analyses needed to judge the symptom findings. The distinction between an endpoint definition and a reported result is central to interpreting this record.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of why study design and outcome reporting matter alongside a clearly named endpoint. TNSS has an explicit construction, a stated direction of interpretation, and a defined assessment time. Those details allow readers to understand what the primary outcome was intended to represent. Yet without an observed estimate and its uncertainty, the endpoint definition alone cannot answer what the study found.
The single-group design is also important. Descriptive measurements can characterize a group, but a comparator is needed for a direct contrast between intervention and control conditions. Without that contrast, any change over time would have limited causal interpretation. This distinction applies broadly to user studies and other uncontrolled designs: the data may describe participants’ reported experience, while leaving attribution uncertain.
The registry’s explicit listing of no analyses is consequential. Without results, analysis populations, or missing-data methods, readers cannot evaluate the magnitude, precision, or robustness of an outcome estimate. This makes transparent reporting of both estimates and their uncertainty essential, not merely the listing of an outcome name and timeframe.
The safety counts illustrate a related point. A zero count is a report about recorded events in the study group, not proof that no possible risk exists. Interpretation depends on how events were defined, collected, and observed—details not reported in the registry record.
Overall, the record helps distinguish a study’s question from the evidence needed to answer it. It documents the intervention, population, endpoint, and some safety counts, while leaving outcome results unavailable. That distinction is valuable for readers assessing what registry information can and cannot establish.
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.
Several trial-specific limitations follow from the registry record. The study is listed as single-group, with allocation recorded as NA and masking as none. No control arm is reported, so the record does not support a like-for-like comparison. Any outcome change would be difficult to attribute specifically to the intervention without a comparator, and the registry does not report a change estimate in any case.
The primary outcome is defined, but its observed mean and 95% confidence interval are not reported in the registry record. The record also does not report a baseline score or explain whether the intended summary was a follow-up value or a change. This leaves the central efficacy-related result unavailable for interpretation. Although headache and facial pain are listed as secondary outcomes, their results are not reported either.
Analysis details are sparse: the registry lists no analyses and does not report an analysis population, statistical model, missing-data handling, or multiplicity procedure. The enrollment entry alone does not establish how many participants contributed outcome data. The registry also does not report details of intervention use, adherence, or symptom-measurement procedures beyond the TNSS definition and assessment time.
Safety reporting is limited to counts. Event descriptions, collection methods, and the observation period are not reported in the registry record. These limitations concern what can be evaluated from the record; they do not establish that the corresponding procedures or data were absent from the study itself.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A User Study of the Soniflow System for Nasal Congestion Relief — NCT04910139.
- Registry record last updated 2023-10-12; status last verified 2023-10.
- Results first posted 2023-10-12.
- 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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18. Record Summary
NCT04910139 is a completed, single-group user study of the Soniflow System in adults with nasal congestion. The registry lists enrollment as 50, no masking, and no randomized allocation. The primary endpoint is mean TNSS at 20 minutes, defined as a sum of four nasal symptom ratings; lower scores are described as better. Headache and facial-pain Visual Analog Scale measures are listed as secondary outcomes.
The registry record does not report the primary or secondary outcome results, confidence interval limits, or analyses. It records 0 serious adverse events, 0 other adverse events, and 0 deaths in the treatment group. The available record identifies the study question and selected safety counts, but does not provide outcome estimates for assessing symptom results.