Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI): Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI) (NCT04468204), a randomized na study. The primary outcome is Total Symptoms Score (TSS).

2. Clinical Question

The study record lists prevention and symptom severity or duration among its aims, but only one outcome measure is posted. The primary result therefore speaks to the recorded TSS outcome, not to every aim described in the study summary. The record does not report a separate result for the number of infections, duration of illness, or each individual symptom.

3. Trial Design

The study is registered as NCT04468204 and is titled Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI). It is marked completed. The registry lists random allocation, single masking, and a parallel-group model. The sponsor is the Medical University of South Carolina. The recorded start date is 2020-10-01 and the primary completion date is 2021-06-30.

The study summary describes two aims: assessing whether the device decreases the number of URIs during an 8 week fall URI season, and assessing severity and duration of community-acquired viral URIs. For both aims, participants were to use either the active SinuSonic device or the sham device. Each was used for 1 min three times a day for 8 weeks. The active device is described as using positive expiratory pressure and 128 Hz; the sham is described as having no positive expiratory pressure and using 1,000 Hz.

The registry records enrollment of 95. The posted primary outcome results list 39 participants in the active group and 13 in the sham group. The record does not explain the relationship between the enrollment figure and the numbers contributing to these outcome summaries. It does not report the reasons for any difference, the number randomized to each group, or the number with missing primary outcome data.

The primary result is a comparison of group means for TSS at the recorded 60 Days timeframe. Although the study summary refers to an 8 week use period, the record does not provide more detail about the timing of TSS collection or the way repeated symptom assessments, if any, were combined for this result. Details of the randomization procedure, allocation concealment, masking assessment, and protocol deviations are not reported in the registry record.

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

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 Total Symptoms Score (TSS), measured over 60 Days.

The primary outcome is Total Symptom Score (TSS), reported as a continuous measure in scores. The record says that the score is based on the severity of upper respiratory infection symptoms and includes 9 symptoms: lost sense of smell or taste, sneezing, runny nose or thick nasal discharge, nasal obstruction or congestion, sore throat, cough, headache, maliase, and chilliness.

Each symptom is rated from 0 to 3: 0 means not at all, 1 mild symptoms, 2 moderate symptoms, and 3 severe symptoms. The stated minimum total score is 0 and the maximum is 27. Thus, the measure combines severity across symptoms into one overall score. A higher score represents greater summed symptom severity under this scoring system.

A continuous score is commonly analyzed by comparing group means, which describes the average score in each group and the average difference between groups. This is a general statistical explanation; the registry record does not give further detail about how individual symptom ratings were collected, whether scores were averaged across days, or how missing symptom ratings were handled.

The record specifies a 60 Days timeframe for the primary outcome. It does not report a clinically important difference for TSS or explain how a particular mean difference should be interpreted as meaningful to participants. The posted TSS result therefore describes the measured score and its statistical uncertainty, rather than establishing the clinical importance of a difference.

7. Results Posted in the Registry

• SinuSonic Device: mean 0.50 versus 0.84 on control; difference -0.34 (95% CI -0.69 to 0.01), standardized effect d = -0.66; z-test p = 0.055.

8. Statistical Interpretation

9. Statistical Methods Explained

The posted outcome is continuous, and the registry identifies the measure as a mean with standard deviation. A comparison of means summarizes the average score in each group and expresses their contrast on the original score scale. Here, the posted group means are 0.503 for the SinuSonic Device group and 0.843 for the sham group. The reported mean difference is -0.34, with the active group subtracted from the sham group in the order stated by the comparison. A negative value therefore corresponds to a lower observed mean in the active group.

What does the mean difference describe?

A mean is the arithmetic average of the observed scores in a group. It provides a compact summary, but it does not show the distribution of individual participants' scores. Two groups can have similar means while differing in their spread or in the shape of their score distributions. The standard deviations reported are 0.501 for the active group and 0.569 for the sham group. These describe variability in scores within each group; they are not confidence intervals for the means.

The mean difference places the contrast on the TSS scale, whose stated range is 0 to 27. A difference on this scale is not automatically clinically important. The registry record does not give a threshold for clinical importance, nor does it report a validated interpretation of a change of this size. Statistical interpretation should therefore distinguish the estimated group contrast from judgments about its practical meaning.

How should the confidence interval be understood?

A confidence interval is a range of values produced by a method designed to have a stated long-run coverage property when its assumptions hold. In general, it communicates the precision of an estimate and the range of effects reasonably compatible with the observed data under the method. It is not a range containing a known true effect with a probability assigned after observing the data. The interval reported for this mean difference runs from -0.687 to 0.007. Because it includes zero, the posted interval does not rule out no mean difference. It also includes negative values, which correspond to a lower mean in the active group under the reported contrast direction, and values just above zero, which correspond to a higher mean in the active group.

What does the p-value add?

The unadjusted p-value is 0.055. In general, a p-value measures how incompatible the data are with a null hypothesis under a specified statistical model. It depends on the model and analysis assumptions, and it does not measure effect size or clinical relevance. It is not the probability that the result is false or the probability that the null hypothesis is true. The registry record does not report the trial's prespecified analysis plan, the hypothesis-testing threshold, or whether any adjustments were intended. The p-value should consequently be considered together with the effect estimate and confidence interval, not used as a binary label for the result.

Why do group sizes and variability matter?

The mean comparison includes 39 participants in the active group and 13 in the sham group. In general, precision depends on both the amount of data and the variability of the outcome. More variable scores and smaller groups tend to leave greater uncertainty around a mean or a difference in means. Unequal group sizes mean that the smaller group can be an important source of uncertainty. The posted group standard deviations describe observed spread, but the record does not report diagnostics for the score distribution or explain any assumptions used to analyze it.

The result is reported as an unadjusted comparison. That term indicates that the posted p-value is not identified as adjusted for multiple comparisons; it does not establish which covariates, if any, were included in the underlying analysis. No adjusted estimate or model description is reported. The record also does not report whether the analysis used an intention-to-treat population, a per-protocol population, or another defined set of participants.

What cannot be inferred from the method details?

The registry reports the mean difference, confidence interval, and unadjusted p-value, but does not describe the calculation method for the interval or test, the handling of missing observations, or whether the analysis accounted for repeated measures. It does not report model diagnostics, sensitivity analyses, subgroup analyses, or an interim analysis plan. These details matter because statistical results depend on how the data were collected and analyzed. Without them, the posted summary supports interpretation of the reported comparison but not independent reconstruction of the full analysis.

General statistical concepts can explain what estimates, variability, intervals, and p-values mean, but they cannot fill gaps in the trial record. The appropriate distinction is between what is posted—the group summaries and comparison—and what is not reported in the registry record, including many choices that would be needed to reproduce or evaluate the analysis in detail.

10. Confidence Intervals and Precision

The reported mean difference is -0.34, and its confidence interval extends from -0.687 to 0.007. The interval is important because it displays uncertainty around the point estimate rather than presenting the estimate as exact. The point estimate is negative, but the interval reaches across zero. The posted result is therefore compatible with no mean difference as well as with differences in either direction under the interval method.

The interval also conveys that estimates nearer to the point estimate are not the only possibilities supported by the data. Its lower endpoint is -0.687 and its upper endpoint is 0.007. The range should not be interpreted as a guarantee that the true difference lies within those endpoints. In general, a confidence interval has a repeated-sampling interpretation: a method with a stated coverage level would capture the target parameter at that rate over repeated use if its assumptions hold. The confidence level and the exact method used for this interval are not reported in the registry record.

The reported group sizes are 39 for the active device and 13 for sham. The smaller sham group contributes less information to the comparison than a larger group might, all else equal. This is a general precision consideration, not an explanation of why those group sizes occurred; that reason is not reported in the registry record. The standard deviations are 0.501 and 0.569, respectively, and describe observed within-group variation.

Precision is distinct from clinical importance. The record does not report a threshold for a meaningful TSS difference, so the interval cannot determine whether any value in its range would matter clinically. It instead shows how uncertain the estimate is on the score scale, subject to the unreported analysis details and assumptions.

11. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning estimates are expressed as participants per arm for this continuous outcome, not as total events. They use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set to the stated fraction of the observed effect. For planning for 100% of the observed effect, the estimates are 37 participants per arm for 80% power and 49 participants per arm for 90% power. For planning for 75% of the observed effect, they are 65 participants per arm for 80% power and 87 participants per arm for 90% power. For planning for 50% of the observed effect, they are 146 participants per arm for 80% power and 196 participants per arm for 90% power.

In plain terms, the 80% power column gives an estimated number of participants per group under the stated assumptions for a design intended to detect the selected effect at that power. The 90% power column gives the corresponding estimate for a design targeting a higher chance of detecting that effect under the same assumptions. These are prospective planning illustrations, not observed power.

The pattern reflects a general principle: smaller effects are harder to distinguish from random variation, so they require more participants for the same target power. These estimates are based on the observed effect in this study and do not document the original trial's design calculation. The original sample-size justification and its assumptions are not reported in the registry record. The planning figures should not be read as evidence that the trial enrolled enough participants to answer its question.

12. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.340; pooled standard deviation σ = 0.518.
2. n = 2 × (1.96 + 0.842)² × 0.518² / -0.340² = 36.5, rounded up to 37 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.34                      # observed difference in means
sigma <- 0.518134538512923                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(4468204)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 37 (80% power), 49 (90% power)
 75% of observed effect: n per arm = 65 (80% power), 87 (90% power)
 50% of observed effect: n per arm = 146 (80% power), 196 (90% power)
power.t.test: 37.4 
Simulated power at n = 37 per arm: 0.794 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

13. Multiplicity, Missing Data and Analysis Populations

The registry record posts one outcome measure and no secondary posted outcomes. The study summary nevertheless describes aims concerning the number of URIs, symptom severity, and symptom duration. The record does not report whether all planned outcomes were registered, whether additional analyses were conducted, or whether there was a prespecified hierarchy among outcomes. The TSS result cannot stand in for unreported results on infection frequency or duration.

Multiplicity arises when several outcomes, time points, groups, or hypotheses are examined. In general, conducting many tests can increase the chance of at least one apparently unusual result, so a statistical plan may specify how to interpret or adjust for multiple comparisons. No multiplicity strategy is reported in the registry record. The posted p-value is identified as unadjusted; no adjusted p-value or multiplicity procedure is posted.

The record does not report an interim analysis plan, stopping rules, or whether interim looks at accumulating data occurred. It also does not describe an analysis population. In particular, it is not reported whether the outcome comparison included everyone randomized, only participants who completed the study, or another subset. Those distinctions can affect how group comparisons are interpreted.

Missing-data handling is not reported. The registry does not state how many participants lacked TSS data, how missing ratings were handled, or whether any imputation or sensitivity analysis was used. The outcome group counts are 39 for the active device and 13 for sham, while the recorded enrollment is 95; the record does not explain this relationship. Without information about missing observations and analysis populations, the posted means cannot be assumed to represent all enrolled or randomized participants.

These omissions do not change the values that are posted, but they limit assessment of how completely the reported comparison reflects the planned study question and how robust it is to alternative analysis choices.

14. 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 2% reporting threshold.

Most frequent non-serious adverse event terms

The serious adverse-event counts are zero in the SinuSonic Device group, among 39 participants at risk, and zero in the sham group, among 13 participants at risk. The record also reports zero deaths in each group. These are event counts in the registry record; they do not establish that no other harms occurred or that the groups had identical safety profiles.

For other adverse events, the record lists 1 affected participant among 39 at risk in the active-device group and 0 among 13 at risk in the sham group. The record does not give a term for that event in the posted summary. Serious and other adverse events are separate categories here, and the zero serious-event counts should not be confused with the other-adverse-event counts.

In general, adverse-event counts need context, including how events were defined, collected, attributed, and followed over time. Those details are not reported in the registry record. The group sizes are also unequal, and a small number of observed events provides limited information about the range of possible event frequencies. These counts describe what was reported; they do not establish comparative safety or prove the absence of risk.

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

The posted primary result describes a lower average TSS in the active-device group than in the sham group: 0.503 versus 0.843. The reported mean difference is -0.34, with a confidence interval from -0.687 to 0.007 and an unadjusted p-value of 0.055. These statistics summarize the observed comparison and its uncertainty. They do not, on their own, establish that the device caused a change in symptoms.

The confidence interval includes zero, so the result does not rule out no mean difference under the reported interval method. It also allows for differences in either direction. The p-value should not be read as the probability that the result is due to chance or as a direct measure of clinical importance. The registry record does not report a clinically important TSS threshold, the confidence level, or enough analysis detail to fully evaluate the calculation.

The result applies to the posted TSS outcome and its recorded 60 Days timeframe. It does not answer every aim described in the study summary. In particular, no result is posted for the number of URIs, duration of illness, or separate symptom components. It also cannot establish how the score changed over time or whether individual participants experienced different patterns, because those details are not reported.

The record identifies random allocation, single masking, and a parallel-group design, but it does not provide detailed information about allocation procedures, masking, missing data, or the analysis population. The observed group summaries should be considered in light of these limitations. The enrollment figure of 95 and the smaller outcome group counts are both recorded, but their relationship is not explained.

The result therefore supports a narrow description: the posted mean TSS was lower in the active group, while the statistical uncertainty includes no difference. It neither proves benefit nor demonstrates no effect. The registry record does not provide enough information to make broader claims about prevention, duration, clinical importance, or all possible safety outcomes.

16. Why This Trial Matters Statistically

This trial illustrates why a point estimate should be read together with its uncertainty. The reported mean difference of -0.34 is easy to interpret in direction, but the confidence interval from -0.687 to 0.007 makes clear that the estimate is not precise enough to exclude no difference. The interval adds information that a single group contrast cannot provide.

It also shows why statistical and clinical interpretations are distinct. TSS is a score with a defined range and symptom-severity components, but the registry record does not identify a threshold for a clinically important difference. Without that context, a numerical contrast cannot be translated directly into a judgment about importance to participants.

The study's listed aims and its posted outcome record do not cover exactly the same scope. The summary refers to infection frequency, severity, and duration, while the registry posts one primary symptom score and no secondary outcomes. This is a useful reminder that conclusions should follow the results actually reported, rather than extend to every aim in a study description.

Finally, the record highlights the role of reporting completeness. Randomized, single-masked, parallel-group design labels provide some structural context, while details about the analysis population, missing data, multiplicity, and sample-size justification are not reported. Those details help readers assess the reliability and limits of a result. Their absence does not invalidate the posted estimates, but it constrains how fully they can be evaluated or generalized.

17. 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 outcome groups contain 39 participants in the active-device arm and 13 in the sham arm, while recorded enrollment is 95. The registry record does not explain the difference or state how many participants were randomized, completed follow-up, or contributed usable TSS data. This limits interpretation of who is represented by the reported means.

The recorded primary outcome timeframe is 60 Days, while the study summary describes use during an 8 week fall URI season. The record does not explain the timing or aggregation of TSS measurements within that period. It also does not state how missing symptom ratings were handled, whether TSS was assessed repeatedly, or which analysis population was used.

The study summary describes aims related to URI frequency, symptom severity, and duration, but only TSS is posted as an outcome measure. No secondary outcome results are posted. The record does not report a clinically important difference for TSS, the original sample-size justification, a detailed statistical analysis plan, or a multiplicity strategy. The exact method and confidence level for the interval are also not reported.

Although random allocation and single masking are recorded, further details about randomization, allocation concealment, the masking process, and protocol deviations are not reported. The registry does not provide subgroup or sensitivity analyses. These limitations restrict assessment of possible bias, robustness, and the extent to which the result represents the full trial population. They also mean that the posted primary comparison should not be extended to outcomes or analysis choices that are not documented.

18. Related Tutorials

19. Related Statistical Calculators

20. Sources

• ClinicalTrials.gov: Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI) — NCT04468204.
• Registry record last updated 2022-12-20; status last verified 2022-11.
• Results first posted 2022-12-20.
• 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.

21. Record Summary

NCT04468204 is a completed randomized, single-masked, parallel-group study sponsored by the Medical University of South Carolina. The registry records enrollment of 95 and describes use of an active or sham SinuSonic device for 1 min three times a day for 8 weeks. The primary outcome is TSS, a continuous symptom-severity score, with a 60 Days timeframe.

The posted mean TSS is 0.503 among 39 participants assigned to the active device and 0.843 among 13 assigned to sham. The reported mean difference is -0.34, with a confidence interval from -0.687 to 0.007 and an unadjusted p-value of 0.055. Serious adverse-event counts and deaths are zero in both groups; one other adverse event is reported in the active group and none in the sham group.

The registry record does not explain the relationship between enrollment and outcome group counts, or report detailed analysis methods, missing-data handling, analysis populations, or a sample-size justification. No secondary outcome results are posted.