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 Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients. (NCT05476328), a na na study. The primary outcome is Monosyllabic Word in Quiet Scores..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05476328 |
| Phase | NA |
| Condition | Hearing Loss |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 8 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cochlear |
| Results posted | Yes |
2. Clinical Question
Population
The umbrella investigation concerned adults and paediatric recipients with a CE-approved Nucleus cochlear implant. The registry summary says subjects older than 5 years would be included and that eligible subjects could be recruited sequentially. The registry enrollment is 8. It does not report the ages or other characteristics of the participants in the primary endpoint population.
Intervention
The registry lists SPACE, OPAL-SPACE, ACE and the Cochlear Device Interface tool as device interventions. The arm description identifies ACE as the reference sound-processing strategy and says SPACE and OPAL-SPACE were evaluated in adult recipients. Details of the evaluation for the full umbrella investigation are not reported in the registry record.
Comparator
ACE is described as the reference strategy, with newer strategies evaluated in relation to it. This is not a randomized comparison: allocation is listed as NA, masking as none, and the study model as single group. The registry record therefore does not establish a randomized, like-for-like control comparison.
Primary question
The listed primary outcome is the percentage of monosyllabic words repeated correctly in quiet, assessed at One Day. The registry description says the score can range from 0% to 100% and that higher scores represent better performance on this measure. The registry record does not include observed scores or an analysis comparing strategies, so the effect or precision of any difference cannot be assessed from the record.
3. Trial Design
This completed investigation is described as a prospective, feasibility umbrella study with sequential enrolment and multiple centres. Its scope includes adults and paediatric recipients with CE-approved Nucleus cochlear implants. The brief summary says subjects older than 5 years would be eligible and describes scheduled visits across different sub-studies, with follow-up over a period up to 5 years. That broad description does not establish the follow-up duration for the primary endpoint, whose listed timeframe is One Day.
The study model is single group. Allocation is listed as NA and masking as none. The arm description identifies ACE as a reference strategy and names SPACE and OPAL-SPACE as strategies evaluated in adult recipients. The interventions list also includes the Cochlear Device Interface tool. These details do not make the investigation a randomized head-to-head trial. In particular, the registry record does not report a randomized sequence or a matched control group for the endpoint.
The registry lists enrollment as 8 and status as completed. The study dates are 2020-01-22 for start and 2023-03-17 for primary completion. The summary describes assessments using commercially available sound processors or other listed equipment when required, and says acute testing and take-home use could be used depending on the evaluation. It also describes questionnaires and at-home tests as possible study activities. The registry record does not report which participants completed each sub-study, the number contributing to the primary measure, or the actual assessment schedule for that measure.
The umbrella investigation's stated goals concern measuring hearing outcomes to assess performance or convenience for implant users and hearing care professionals. Those broad aims should not be confused with evidence for a particular strategy on the listed primary endpoint: the registry record contains no observed score results or reported statistical analysis.
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 participant flow includes only one group as this was a repeated measures, single-arm study where all participants were exposed to all sound processing strategies. Data from the same participants was collected multiple times across different conditions. The focus was on assessing effects within the same group under varying conditions, making it a single-arm design with repeated measurements on each participant.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 8 |
| ACE Strategy | 8 |
| SPACE Strategy | 8 |
| OPAL-SPACE Strategy | 8 |
| COMPLETED | 8 |
| NOT COMPLETED | 0 |
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 | All Participants |
|---|---|---|
| Participants analysed | 8 | |
| Age, Continuous | years | 69 (61 to 76) |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 5 |
| Race and Ethnicity Not Collected | Participants | — |
| Clinical Device in Test Ear: N7 CI24RE | Participants | 3 |
| Clinical Device in Test Ear: N7 CI512 | Participants | 5 |
6. Primary Endpoint
The registry lists the primary outcome as Monosyllabic Word in Quiet Scores., measured over One Day.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Percentage of words repeated correctly |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the monosyllabic word in quiet score, expressed as the percentage of words repeated correctly. It is listed as a continuous outcome summarized by a mean and standard deviation, with a timeframe of One Day. The registry description defines the possible score range as 0% to 100% and states that a higher percentage means a better score on this measure.
A word-recognition score provides a direct summary of correct responses during a specified listening task. In general, continuous scores can show gradations of performance rather than reducing outcomes to categories such as success or failure. Reporting the mean describes the average score in the measured group, while the standard deviation describes how spread out individual scores are around that average. The standard deviation is not the same as the uncertainty around the mean.
The endpoint is relevant to an investigation of sound-processing strategies because it measures word repetition in quiet, one of the listening conditions named by the outcome. It does not by itself describe performance in other listening environments, user convenience, or take-home acceptance. The registry record does not report the observed mean, standard deviation, contributing participant count, or a treatment contrast for this endpoint. Consequently, its actual results and their precision cannot be interpreted from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically interpretable outcome and describes the direction of its scale: a higher percentage of monosyllabic words repeated correctly indicates a higher score. However, it does not report any observed endpoint values. There is therefore no registry-reported mean or standard deviation to characterize, and no reported estimate of a difference between ACE, SPACE or OPAL-SPACE. Neither the direction nor size of a strategy effect can be established from the record.
The study's single-group model and lack of masking matter when interpreting its design. ACE is called the reference strategy in the arm description, but the record does not describe a randomized allocation to strategies. The listed strategy evaluations should not be read as a randomized comparison or as evidence that the groups, assessment order, or other conditions were comparable. The registry record does not report the sequence of strategy assessments or how potential order and learning effects were handled.
Precision also cannot be judged from an endpoint estimate because the record gives no estimate, confidence interval, or test result. In general, a confidence interval describes the range of values reasonably compatible with an estimated effect under the analysis assumptions; it is not reported for this endpoint in the registry record. Statistical significance, if reported, would not by itself convey the size or practical relevance of an effect. Here, no p-value or inferential result is reported.
The registry enrollment is 8, and the adverse-event listing records 8 participants at risk in the all-participants group. These figures do not tell how many contributed endpoint data. A denominator for the primary outcome, missing score information, and analysis population are not reported in the registry record. The small enrollment and absence of outcome details leave the endpoint's precision and representativeness unclear; no additional estimate of uncertainty can be derived without inventing data.
The study is described as a feasibility investigation within a broader umbrella program, with several strategies and sub-studies. The primary endpoint record is only one part of that scope. The record does not report a statistical analysis for the endpoint, nor does it state whether other analyses were performed outside the registry. As a result, the posted information supports a description of the planned measure and overall design, but not a conclusion about the comparative performance of the strategies.
9. Statistical Methods Explained
The registry identifies a continuous outcome summarized by a mean and standard deviation. It does not report an analysis for that outcome. The following explains how these statistics are generally used and what can and cannot be inferred from the record.
What does a mean describe?
For a continuous measure, the mean is the arithmetic average of the observed scores in the analysis group. For the word score, it would express average percentage correct. It is a compact description of the group's central level of performance, but it does not reveal whether scores were tightly clustered or widely dispersed. It can also be influenced by unusually high or low observations. The registry record does not give the endpoint mean, so the group's observed level cannot be described.
What does the standard deviation describe?
The standard deviation describes how much individual scores vary around the mean. It is a measure of dispersion among observations, not a measure of how precisely the mean has been estimated. A small standard deviation would indicate less variation in scores within the measured group; a large one would indicate more variation. Those interpretations are general, and no endpoint standard deviation is reported in the registry record.
How is uncertainty about an estimate expressed?
In general, a confidence interval gives a range of values compatible with the observed data and a stated statistical procedure. Its width reflects uncertainty: wider intervals indicate less precision than narrower intervals. A confidence interval for a mean or a difference is not the same as the standard deviation of individual scores. The registry record does not report a confidence interval for the primary endpoint or a strategy contrast. No interval can be reconstructed from the information recorded.
What would a strategy contrast require?
A contrast would quantify how scores differ between strategies under a defined comparison. Interpreting such a contrast depends on how strategies were assigned or ordered, which participants contributed measurements, and what analysis accounted for repeated observations. The registry labels the model as single group and allocation as NA, and describes ACE as a reference strategy. It does not report a randomized allocation, a contrast estimate, or a method for handling repeated measures. Therefore, the label reference should not be taken to imply a randomized control comparison.
Repeated measurements can be statistically dependent because observations from the same person tend to share characteristics. General methods for repeated measures account for that dependence rather than treating every score as independent. The official title describes a repeated-measures investigation, but the registry record does not report the model, covariance assumptions, or analysis used for this endpoint. It is not possible to say how dependence was handled.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. If a model understates variability, its uncertainty estimates can be too small and its intervals or tests may be overly optimistic. This concept is relevant only when the selected model has a dispersion assumption that can be violated. The registry record does not identify a model for the word score or report a dispersion assessment, so no claim about over-dispersion in this study is possible.
What do the planning illustrations mean?
The planning assumptions describe illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is expressed as a fraction of the observed effect. These are planning illustrations, not observed power and not evidence that the trial was designed with those assumptions. The registry record does not report the trial's own sample-size justification. The observed endpoint effect needed to understand the illustrations is not reported in the registry record, so no planning value should be interpreted as a trial result.
In general, a sample-size calculation estimates how many participants per arm a hypothetical future study might require under stated assumptions. It depends on the effect chosen for detection, the outcome variability, the significance level, the desired power, and the analysis design. If the assumed effect is smaller, more participants are generally needed to distinguish it from random variation, all else equal. Such calculations are sensitive to assumptions and should not be confused with the precision or power observed in a completed study. The registry record provides no endpoint estimate with which to assess the realism of the planning effect.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure, but it also describes an umbrella investigation with different sub-studies and several sound-processing strategies. A single listed outcome does not establish that only one statistical comparison or analysis was conducted. The registry record reports 0 analyses and does not describe a multiplicity adjustment, a prespecified testing hierarchy, or how results across strategies or sub-studies were handled. Whether multiple testing was relevant to the sponsor's analyses is not reported in the registry record.
Multiplicity is a general concern when many hypotheses or comparisons are tested: the chance of at least one apparently notable result can increase as the number of tests increases. Statistical approaches can control that risk, but the appropriate method depends on the analysis plan and scientific questions. No multiplicity method is reported for this endpoint.
Missing outcome data also affect interpretation. The registry enrollment is 8, but the number with a recorded primary score and the number included in any analysis are not reported in the registry record. The record does not describe reasons for missing scores, how missing measurements were handled, or whether the analysis used all available observations. In general, excluding participants with missing outcomes can bias an estimate when the likelihood of missingness is related to participant characteristics or outcomes. Methods for incomplete repeated measurements rely on assumptions that should be made explicit; those assumptions and methods are not reported.
The analysis population is not specified. The record does not say whether the endpoint population included all enrolled participants, only those who completed a particular assessment, or another defined group. Therefore, the results cannot be assessed for attrition or alignment with an intended analysis population.
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 |
|---|---|---|---|
| All Participants | 0 | 8 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| All Participants | 0 of 8 |
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 |
|---|---|
| All Participants | 0 of 8 |
The registry adverse-event listing describes an all-participants group with 8 at risk for serious adverse events and 0 affected. It also records 8 at risk for other adverse events and 0 affected, with 0 deaths. These are the counts recorded for this study; they are not comparative rates and do not establish a difference between sound-processing strategies.
In general, an at-risk count is the group size used as the event-reporting denominator, while an affected count indicates how many participants were recorded as having an event in the specified category. A zero affected count means no events in that category were recorded for the listed group. It does not prove that the risk is absent, and it should not be interpreted as a precise estimate of risk without considering study size, follow-up, event definitions, and completeness of reporting.
The registry does not list serious-event terms, and the record does not provide further detail on event definitions, severity, timing, attribution, or duration of safety surveillance. The brief study summary describes assessments over differing schedules across sub-studies, but does not establish the safety follow-up applicable to these counts. These figures should therefore be read as registry-reported counts, not as a complete account of safety or as evidence about comparative safety.
12. What the Result Does, and Does Not, Mean
The registry record establishes that a completed, single-group feasibility investigation listed monosyllabic word in quiet score as its primary outcome. It gives the scale, the direction of better scores, the summary statistics intended for the continuous measure, and the One Day timeframe. It also describes ACE as a reference strategy and lists SPACE and OPAL-SPACE among the strategies evaluated. These details clarify what the outcome was intended to measure and the broad setting in which it was studied.
The record does not report the observed word scores, a mean or standard deviation, a strategy contrast, a confidence interval, a p-value, or an endpoint analysis. It therefore cannot show whether scores differed across strategies, how large any difference may have been, or how precisely an effect was estimated. No conclusion about the effectiveness of any strategy follows from the endpoint description alone.
The design also limits causal interpretation. Allocation is NA, masking is none, and the model is single group. The registry description does not establish randomized assignment to the strategies. Without reported allocation and analysis details, any apparent difference—if results were available—could not automatically be attributed to the sound-processing strategy rather than to other aspects of assessment or study conduct.
The umbrella study covers wider goals and activities than the primary word-in-quiet measure. A score in quiet would not, by itself, answer questions about other listening environments, take-home acceptance, or convenience. The registry record does not report findings for those broader aims in the material describing the primary outcome.
The posted information is therefore useful for understanding the intended endpoint and study structure, but insufficient for judging the direction, magnitude, precision, or clinical importance of a treatment effect. The absence of reported endpoint results is not evidence of no effect; it means the effect cannot be assessed from the registry record.
13. Why This Trial Matters Statistically
Feasibility investigations can be statistically informative even when they are not designed as definitive comparative trials. In general, they can describe whether assessments are practicable, identify measurement issues, and help frame later study questions. This record places those aims in the context of an umbrella investigation of sound processing for adult and paediatric cochlear implant recipients. Its primary endpoint is a clearly defined performance measure: the percentage of monosyllabic words repeated correctly in quiet.
The design is important to statistical interpretation. The registry labels the investigation single group, with allocation NA and no masking. That description prevents readers from treating strategy evaluations as randomized comparisons. The study title also identifies a repeated-measures investigation, a design in which observations from one participant may be related. Appropriate analysis of such data depends on the measurement schedule, participant-level records, and statistical model; those details are not reported in the registry record.
The record highlights a recurring distinction in clinical research: a stated outcome and a completed study are not substitutes for reported estimates. Without observed scores, uncertainty measures, and analysis details, neither the size nor precision of the endpoint result can be evaluated. The registry enrollment of 8 makes transparent the scale of the recorded study, but does not establish how many participants contributed to the endpoint or what the outcome showed.
The record also illustrates why safety counts require context. Zero affected participants in the listed categories is a descriptive report, not proof that events cannot occur or a comparison of strategies. More broadly, feasibility, outcome measurement, comparative inference, and safety assessment are related but distinct statistical questions. The registry record supports a careful account of the first and of the measurement plan, while leaving comparative outcome interpretation unresolved.
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 registry record does not provide observed values for the primary endpoint. Without the mean, standard deviation, or participant-level results, readers cannot assess the score distribution, the average performance, or the variation among participants. It also gives no endpoint confidence interval, p-value, effect estimate, or comparison between strategies.
The design is described as single group, with allocation listed as NA and masking as none. The record does not report a randomized comparison, strategy order, or method for addressing possible order or learning effects. The arm description refers to adult recipients for the evaluation of ACE, SPACE and OPAL-SPACE, while the overall investigation includes adults and paediatric recipients. The endpoint population is blank, so the composition of the population contributing to the primary measure is not reported in the registry record.
Although the umbrella summary describes follow-up and multiple sub-studies, it does not give the primary endpoint's analysis population, the number with measured scores, missing-data handling, or the statistical model. The repeated-measures title makes the analysis of within-participant dependence potentially relevant, but the method used is not reported. The registry record also does not describe multiplicity handling across strategies, outcomes, or sub-studies.
The enrollment of 8 limits what can be learned about uncommon events or broad variation, but the registry record does not give enough outcome information to quantify the precision of the primary measure. The adverse-event listing records zero affected participants in its categories, without further detail on event definitions or duration of safety reporting. These registry limitations restrict interpretation and should not be filled by assumptions about the protocol or analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sound Processing Innovations in Adult and Paediatric Cochlear Implant Recipients. — NCT05476328.
- Registry record last updated 2025-02-13; status last verified 2025-02.
- Results first posted 2025-02-13.
- 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
NCT05476328 is listed as a completed, prospective, multicenter feasibility investigation of sound-processing strategies in adult and paediatric cochlear implant recipients. The registry describes a single-group model, allocation NA, and no masking. It lists enrollment as 8, with a start date of 2020-01-22 and primary completion date of 2023-03-17.
The primary outcome is monosyllabic word in quiet score, measured as percentage of words repeated correctly, summarized by mean and standard deviation, with a One Day timeframe. The listed strategies include ACE, SPACE and OPAL-SPACE. The registry record does not report observed endpoint results or a statistical analysis. The adverse-event listing records 0 serious adverse events, 0 other adverse events, and 0 deaths in the all-participants group.