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 High Dose Oxytocin Nasal Spray for Treatment of Tinnitus (NCT04210310), a randomized phase 3 study. The primary outcome is Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT04210310 |
| Phase | Phase 3 |
| Condition | Tinnitus |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 33 |
| Arms in the primary outcome | n/a |
| Lead sponsor | NYU Langone Health |
| Results posted | Yes |
2. Clinical Question
Population
People with tinnitus were the intended study population. The registry lists tinnitus as the condition and records enrollment of 33 participants. Further eligibility details are not reported in the registry record.
Intervention
High-dose intranasal oxytocin. The arm description says participants were to use one spray in one nostril four times daily, at 9AM, 1PM, 5PM and 9 PM, throughout the study.
Comparator
A placebo nasal spray, with the same described schedule of one spray in one nostril four times daily throughout the study. The registry does not report further details about the placebo.
Primary question
The intended question was whether tinnitus loudness, rated on a visual analogue scale (VAS), changed from baseline to Week 9 in the oxytocin group compared with the placebo group. The registry states that the study ended prematurely and primary outcome data were not collected, so it does not answer that comparison.
The study title describes a pilot, proof-of-concept, placebo-controlled, parallel study, while the registry classifies its phase as Phase 3. It was randomized and double-masked. Those design features describe how the trial was planned; they do not establish that the planned comparison was completed or that the outcome was measured.
The stated hypothesis was that high-dose intranasal oxytocin could reduce tinnitus severity and disability. The registered primary outcome specifically concerned loudness ratings, not a reported result for severity or disability. The record does not provide outcome data with which to evaluate either the primary question or the broader hypothesis.
3. Trial Design
NCT04210310, titled “High Dose Oxytocin Nasal Spray for Treatment of Tinnitus,” was sponsored by NYU Langone Health. The registry classifies it as Phase 3, randomized, double-masked and parallel-group. Its official title describes a pilot, proof-of-concept, placebo-controlled study. These descriptions are part of the registry record; no further explanation of how the pilot designation relates to the Phase 3 classification is reported.
The intervention was high-dose intranasal oxytocin, compared with a placebo nasal spray. Both arm descriptions specify one spray in one nostril four times daily throughout the study. The placebo description says the spray could be taken with or without food. No additional information about concealment, the identity of masked parties, or the procedures for maintaining masking is reported in the registry record.
The record lists enrollment of 33. It gives a start date of 2020-01-15 and a primary completion date of 2022-05-10, and lists the study status as terminated. The stated reason was that the principal investigator and study team departed the institution. The record does not describe whether participants completed treatment or follow-up before termination, or how enrollment was distributed between arms.
Although the trial was randomized and placebo-controlled, those features cannot compensate for the absence of primary outcome data. The registry records one outcome measure but no analyses. Details such as the randomization method, planned analysis model, sample-size justification, and analysis populations 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.
Before assignment: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available.
Overall Study
| Stage | High-dose Intranasal Oxytocin | Nasal Spray |
|---|---|---|
| STARTED | 32 | 1 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 32 | 1 |
Reasons for not completing this period:
| Reason | High-dose Intranasal Oxytocin | Nasal Spray |
|---|---|---|
| Lost to Follow-up | 32 | 1 |
Analysis population for the primary outcome, as defined in the registry: Study was terminated prematurely due to PI and study team departing the institution. Data were not collected for the primary outcome measure.
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.
| Characteristic | Unit | High-dose Intranasal Oxytocin | Nasal Spray | Total |
|---|---|---|---|---|
| Participants analysed | 32 | 1 | 33 | |
| Age, Continuous | years | 59.9 (SD 11.5) | 66 (SD 0) | 60.1 (SD 11.3) |
| Sex: Female, Male: Female | Participants | 5 | 0 | 5 |
| Sex: Female, Male: Male | Participants | 27 | 1 | 28 |
| Race and Ethnicity Not Collected | Participants | — | — | 0 |
| Region of Enrollment: United States | participants | 32 | 1 | 33 |
6. Primary Endpoint
The registry lists the primary outcome as Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness, measured over Baseline, Week 9.
| Element | Registry entry |
|---|---|
| Result type | N/A |
| Measure of spread | not applicable |
| Unit | not stated |
| Endpoint classification | not reduced to a single comparison |
The primary outcome was change in VAS-rated tinnitus loudness, assessed at baseline and Week 9. Participants rated loudness on an 11-point Likert scale from 0, the minimum, to 10, the maximum; higher scores indicate greater tinnitus loudness. A participant-level change would describe how the rating differed between the two stated assessment times. The registry does not report a group-level change or a comparison between arms.
A self-rating scale is used to capture the participant’s perception of tinnitus loudness, an experience that is not directly represented by an external measurement in this outcome definition. The score makes that rating expressible on a common scale, but it remains a participant-reported measure. A change in score would summarize reported loudness, not every aspect of tinnitus severity, disability, or daily experience.
The registry defines no response to nasal spray as a decrease in VAS score of less than 2 and patient-reported improvement as a decrease of more than 3. Those definitions do not specify how decreases of exactly 2 or exactly 3 are categorized. More importantly, the record says primary outcome data were not collected because the study was terminated prematurely. The endpoint’s scale and interpretation are described, but its observed values and any treatment comparison are not available.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The central statistical fact is that the primary outcome was not collected. The registry therefore contains no VAS change estimate for either arm and no estimate of the difference between oxytocin and placebo. There is no reported confidence interval, test statistic, or p-value for the primary question. Without an outcome estimate, the magnitude and precision of any treatment effect cannot be assessed from the registry record.
This is different from a result showing no change or no difference. A null or near-null estimate would still require collected outcome data and would have a degree of uncertainty. Here, there is no primary outcome result to interpret. The missing result cannot be treated as evidence that the groups were alike, nor can the study’s stated hypothesis be treated as confirmed.
The registry reports 33 participants enrolled and states that termination followed the departure of the principal investigator and study team. It does not say how many participants received each intervention, how many completed follow-up, or whether any partial primary-outcome observations were available. The primary outcome population is explicitly described as having no collected data. The record lists no analyses, so there is no registered analysis result to place alongside the missing endpoint.
The safety record contains adverse-event counts, but these do not fill the efficacy gap. The registry records one serious adverse event in the high-dose oxytocin group, where 32 participants were at risk, and none in the nasal-spray group, where 1 participant was at risk. It records other adverse events in both groups as well. The very different at-risk counts make the groups difficult to compare descriptively, and the registry provides no inferential comparison. These figures should not be used to infer a primary treatment effect or a causal safety difference.
In general, an estimate is more informative when accompanied by an uncertainty interval: the interval conveys how compatible the data are with a range of effects under the analysis assumptions. No such interval for the primary endpoint is reported. Consequently, neither the direction of a VAS effect nor its statistical precision can be described. The registry’s termination status and explanation clarify why the intended question remains unanswered, but they do not supply an alternative outcome estimate.
9. Statistical Methods Explained
The registry describes a randomized, double-masked, parallel study with a placebo comparator. In general, randomization is intended to make treatment groups comparable with respect to measured and unmeasured characteristics, while masking is intended to reduce influences on participant experience, care, and outcome assessment. A parallel design assigns participants to an intervention group that is compared with another group. These are general purposes of the design features; the registry record does not give enough detail to assess how randomization or masking was implemented.
What would the primary comparison estimate?
The outcome was a VAS rating of tinnitus loudness at baseline and Week 9. A treatment comparison would ordinarily summarize change over that interval in each group and compare those changes, or use another prespecified approach to compare the groups at follow-up. The registry does not report the planned statistical model or specify which form of comparison was intended. Since primary outcome data were not collected, no such estimate is available regardless of the method that might have been planned.
In general, a confidence interval describes uncertainty around an estimated effect under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval that includes effects in multiple directions may leave the direction uncertain. These concepts cannot be applied to the primary outcome because the registry reports neither an estimate nor an interval. No p-value for the primary comparison is reported either. The absence of those statistics reflects the missing primary result, not a reported statistical test that failed to reach a threshold.
How should the planning assumptions be read?
The registry describes a planning illustration using a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation. It also describes planning effects as stated fractions of an observed effect. In general, a sample-size calculation estimates how many participants would be needed under chosen assumptions about the effect, variability, allocation, and analysis. Such a calculation is a planning aid, not an observed study result and not evidence that a trial had a particular probability of finding an effect.
The distinction between planning and observed evidence matters especially in this record. The registry says no primary outcome data were collected, so it does not report a primary VAS effect from which readers can judge a treatment estimate. Planning illustrations based on an observed effect should not be mistaken for results from this trial. The record does not report the trial’s sample-size justification or explain whether any planning calculation informed the design.
In general, the normal approximation can be useful when its assumptions adequately represent the data and the target estimate. It may be less suitable when data are sparse, strongly skewed, or otherwise poorly represented by the approximation. These are general considerations, not findings about this study: the missing primary outcome prevents assessment of the observed VAS distribution or its variability.
What can the adverse-event counts establish?
Adverse-event counts are descriptive safety information, not a substitute for the primary efficacy outcome. The registry reports serious and other adverse events in groups with markedly different numbers at risk. With limited information about exposure, follow-up, event definitions, and ascertainment, simple counts alone cannot establish comparative risk. The record does not report an inferential safety analysis, adjustment, or causal assessment. General statistical interpretation therefore calls for attention to the at-risk population and follow-up, not just the event totals.
Over-dispersion is a general issue in count data: it occurs when variability exceeds what a simple count model assumes and can make uncertainty estimates too small if ignored. Nothing in this record reports a count model or enough event data to assess over-dispersion. It would be inappropriate to claim that this issue did or did not affect an analysis that the registry does not report.
What analysis details remain unknown?
The registry does not report a prespecified analysis model, an analysis population, handling of missing observations, or adjustment for other variables. It also does not report interim analyses, stopping rules, or a statistical plan. The stated reason for termination is the departure of the principal investigator and study team; the record does not attribute termination to an interim efficacy or safety analysis. Without these details and without primary outcome data, there is no basis for reconstructing an analysis or assessing its assumptions.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, but the outcome description includes two assessment times, baseline and Week 9, and defines more than one category of change. The record’s outcome note says the primary outcome has several categories or time points and was not reduced to one comparison. This means there is no single posted primary comparison to interpret. The intended hierarchy among any outcome categories or time points is not reported in the registry record.
Multiplicity arises in general when multiple hypotheses or outcome comparisons are examined: the chance of obtaining at least one apparently unusual result can increase as the number of comparisons grows. A prespecified testing strategy can address that issue, but no multiplicity procedure is reported. Because the primary outcome data were not collected, the record does not show whether multiple comparisons were tested or how any such tests would have been handled.
For missing data, the registry gives a specific statement: the study was terminated prematurely after the principal investigator and study team departed the institution, and data were not collected for the primary outcome measure. This is not a report of a completed analysis in which some primary observations were missing and modeled or imputed. The extent of any other missing information, the follow-up status of participants, and any missing-data strategy are not reported in the registry record.
Analysis populations are also not described. The record does not say whether analyses were intended to include everyone randomized, only participants who received treatment, or another group. It lists no analyses. Accordingly, neither the population used for an efficacy estimate nor the handling of participants who may not have completed the study can be assessed.
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 |
|---|---|---|---|
| High-dose Intranasal Oxytocin | 1 | 32 | 3.1% |
| Nasal Spray | 0 | 1 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| High-dose Intranasal Oxytocin | 0 of 32 |
| Nasal Spray | 0 of 1 |
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 |
|---|---|
| High-dose Intranasal Oxytocin | 6 of 32 |
| Nasal Spray | 0 of 1 |
Most frequent serious adverse event terms
| Event term | Organ system | High-dose Intranasal Oxytocin | Nasal Spray |
|---|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | 1 of 32 | 0 of 1 |
Most frequent non-serious adverse event terms
| Event term | Organ system | High-dose Intranasal Oxytocin | Nasal Spray |
|---|---|---|---|
| Mild Nasal Congestion | Respiratory, thoracic and mediastinal disorders | 1 of 32 | 0 of 1 |
| Atypical, intermittent chest pain | Cardiac disorders | 1 of 32 | 0 of 1 |
| Mild Headache | Nervous system disorders | 1 of 32 | 0 of 1 |
| Intermittent Dizziness | Nervous system disorders | 1 of 32 | 0 of 1 |
| Bronchitis | Infections and infestations | 1 of 32 | 0 of 1 |
| Diarrhea | Gastrointestinal disorders | 1 of 32 | 0 of 1 |
| Increased urination | Renal and urinary disorders | 1 of 32 | 0 of 1 |
Serious events with the highest arm-level rate: dyspnea (3.1%).
The registry reports serious adverse events separately from other adverse events. In the high-dose intranasal oxytocin group, 32 participants were listed as at risk for serious adverse events and 1 participant was recorded as affected; 32 were listed as at risk for other adverse events and 6 were affected. In the nasal-spray group, 1 participant was listed as at risk in each category, with 0 affected for serious and other adverse events. Deaths were recorded as 0 in both groups.
These are registry counts, not adjusted comparisons. The at-risk group sizes differ substantially, and the record does not explain why the nasal-spray group has 1 participant at risk while the oxytocin group has 32. It does not report event timing, duration of exposure, statistical testing, or whether events were judged related to the intervention. The listed serious-event term Dyspnea is accompanied by 3.1%; the record does not provide further context for that percentage in the listed term.
In general, counts should be read alongside the population at risk and the way events were collected. The figures do not establish a causal effect or support a reliable comparison between groups. They also do not address the missing primary outcome.
12. What the Result Does, and Does Not, Mean
The record documents a randomized, double-masked, placebo-controlled trial intended to examine high-dose intranasal oxytocin for tinnitus. It also documents that the study terminated prematurely after the principal investigator and study team departed the institution. Most importantly for interpreting efficacy, the primary VAS outcome was not collected. The posted results therefore do not show whether tinnitus loudness changed, or whether any change differed between the intervention and placebo groups.
This is an inconclusive record for the primary treatment question, rather than a positive or negative efficacy result. No treatment effect estimate or uncertainty interval is reported. The stated hypothesis is a description of what investigators expected to examine, not evidence that the expected effect occurred. Likewise, the lack of an observed endpoint is not evidence that oxytocin had no effect.
The registry’s safety counts describe recorded adverse events in groups with unequal numbers at risk. They do not establish that the interventions caused or prevented events, and they do not answer the efficacy question. The registry does not report enough information to resolve why the at-risk counts differ or to make a robust comparative safety assessment.
In general, a trial can contribute useful evidence only to the extent that relevant outcomes are collected and reported with enough detail to interpret the estimates. Here, design features and the endpoint definition are available, but the primary result and analysis details are not. The record supports describing the intended comparison and the reason given for termination; it does not support a conclusion about treatment benefit or lack of benefit.
13. Why This Trial Matters Statistically
This trial illustrates an important distinction between a registered design and an interpretable result. Randomization, masking, a placebo comparator, and a clearly described rating scale can support a rigorous comparison when outcomes are collected and analyzed. They do not produce an estimate by themselves. The registry reports that termination occurred before primary outcome data were collected, leaving the central comparison unresolved.
It also demonstrates why enrollment alone is not enough to understand a trial’s statistical information. The record lists 33 participants enrolled, but does not report the number in each planned arm for the primary outcome, a completed follow-up population, or any endpoint estimates. The adverse-event groups have different numbers at risk, which further cautions against treating the recorded counts as a balanced comparison.
For clinical research interpretation, a missing outcome is not interchangeable with a null finding. A null estimate can be evaluated for precision and compatibility with meaningful effects; no estimate cannot. This difference matters when readers encounter a stated hypothesis or a trial design that appears capable of addressing a question. The registry’s explicit statement that primary data were not collected prevents the design from being mistaken for evidence about the outcome.
Finally, the record underscores the value of clear reporting about termination, analysis populations, and missing data. The stated reason for stopping is documented, but the record does not report planned analysis details or interim analyses. Those omissions limit statistical reconstruction and leave the primary efficacy question unanswered.
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 main limitation is that no data were collected for the primary outcome. There is consequently no VAS estimate, no between-group comparison, and no reported uncertainty for the intended efficacy question. The endpoint definition does not change that limitation: it explains how loudness was to be rated, but not what participants reported.
The study terminated prematurely because the principal investigator and study team departed the institution, according to the registry. The record does not describe how many participants completed treatment or follow-up, when participants left the study, or whether any secondary outcome data were collected. It also does not report the allocation of enrolled participants between arms. These gaps make it difficult to describe the extent of participation or the available safety follow-up beyond the adverse-event counts.
The safety counts have unequal numbers at risk across groups, and the record gives no explanation for that difference. It does not report exposure duration, event ascertainment procedures, relatedness assessments, or comparative safety analyses. The serious-event term listing also offers limited context. These details constrain interpretation of the adverse-event information.
Other statistical details are not reported in the registry record, including the sample-size justification, randomization procedures, planned analysis model, analysis populations, handling of missing data, and multiplicity strategy. The record also does not report interim analyses or stopping rules. These limitations do not imply that such procedures were absent from all study materials; they mean they cannot be evaluated from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: High Dose Oxytocin Nasal Spray for Treatment of Tinnitus — NCT04210310.
- Registry record last updated 2022-10-05; status last verified 2022-09.
- Results first posted 2022-10-05.
- 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
NCT04210310, “High Dose Oxytocin Nasal Spray for Treatment of Tinnitus,” was sponsored by NYU Langone Health. The registry describes a randomized, double-masked, parallel, placebo-controlled study and classifies it as Phase 3. Enrollment was 33. The recorded start date was 2020-01-15, and the primary completion date was 2022-05-10. The study status is terminated.
The intended primary outcome was change in VAS-rated tinnitus loudness from baseline to Week 9. The registry states that the study ended prematurely after the principal investigator and study team departed the institution, and that primary outcome data were not collected. No analyses are listed. The record includes serious and other adverse-event counts, but those counts come from groups with different numbers at risk and do not provide an efficacy result.
The registry record therefore describes the intended design and endpoint, but does not report a primary treatment-effect estimate. Further statistical analysis details are not reported in the registry record.