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 Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults (NCT05265260), a registered phase not stated study. The primary outcome is Score of the French MBAA2 Sentence Recognition Test in Quiet.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05265260 |
| Phase | Phase not stated |
| Condition | Sensorineural Hearing Loss, Bilateral |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 32 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cochlear |
| Results posted | Yes |
2. Clinical Question
Population
Adults currently using a Nucleus cochlear implant. The registry lists bilateral sensorineural hearing loss as the condition and records enrollment of 32 participants. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
This is described as a non-interventional feasibility study, so no assigned treatment or intervention is specified. The study aim is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition scores in adults using a Nucleus cochlear implant.
Comparator
No comparator group is specified. The registry does not describe a randomized comparison, and the record indicates that any arms are not a like-for-like control comparison. Details of how participants or measurements might be compared are not reported in the registry record.
Primary question
At 1 month post activation, how many participants meet the registry’s definition of good performance on the French MBAA2 Sentence Recognition Test in Quiet, and how many fall below that threshold? A good performer is defined as scoring ≥90/100 correct sentence; a bad performer is defined as scoring <90/100 correct sentence. The registry does not report the observed counts or the relationship between the other listed domains and the score.
3. Trial Design
The study is registered as a non-interventional feasibility study under the title “Barriers to Early Progress in Cochlear Implant Outcomes: a Non-interventional Feasibility Study.” Its aim is to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition scores among adults currently using a Nucleus cochlear implant. The condition listed is bilateral sensorineural hearing loss.
The registry lists enrollment of 32 and a status of completed. The recorded study start is 2022-04-21, and the primary completion date is 2022-09-20. Cochlear is listed as the sponsor. These record details do not establish how participants were recruited, which measurements were collected, or how they were scheduled; those details are not reported in the registry record.
The study is not described as a randomized comparison. The record explicitly cautions that allocation is not stated and that arms are not a like-for-like control comparison. No assigned intervention or comparator is described. The registry lists 1 outcome measure and no analysis entries. Consequently, the record identifies a study objective and a primary outcome definition, but does not provide a complete account of the analysis plan or results.
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 | Adults Using Currently a Nucleus Cochlear Implant |
|---|---|
| STARTED | 32 |
| COMPLETED | 32 |
| 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 | Adults Using Currently a Nucleus Cochlear Implant |
|---|---|---|
| Participants analysed | 32 | |
| Age, Continuous | years | 70.0 (SD 13.5) |
| Sex: Female, Male: Female | Participants | — |
| Sex: Female, Male: Male | Participants | — |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | — |
| Race (NIH/OMB): Asian | Participants | — |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | — |
| Race (NIH/OMB): Black or African American | Participants | — |
| Race (NIH/OMB): White | Participants | — |
| Race (NIH/OMB): More than one race | Participants | — |
| Race (NIH/OMB): Unknown or Not Reported | Participants | — |
| Region of Enrollment: France | participants | 32 |
6. Primary Endpoint
The registry lists the primary outcome as Score of the French MBAA2 Sentence Recognition Test in Quiet, measured over 1 month post activation.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the count of participants classified by their score on the French MBAA2 Sentence Recognition Test in Quiet. The measurement time is 1 month post activation. The registry defines a good performer as a participant with a score of ≥90/100 correct sentence and a bad performer as a participant with a score of <90/100 correct sentence. This turns a test score into a binary outcome: each participant is assigned to one of the two stated categories according to the cutoff.
A threshold can make an outcome easier to describe in terms of the proportion of participants meeting a prespecified category, if those counts are reported. It also discards distinctions among scores within each category. Participants with different scores can be grouped together when they fall on the same side of the cutoff. The registry record does not report the number in either category, the underlying score distribution, or any analysis relating the endpoint to audiometric, cognitive or electrophysiological results.
The endpoint is relevant to the stated study aim because it records sentence recognition performance at the specified post-activation time. The registry does not explain why this particular cutoff was selected, whether other score summaries were planned, or how the endpoint was to be incorporated into analyses.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes the study’s question and the definition of its primary outcome, but it does not provide the outcome results. It does not report how many participants scored ≥90/100 or how many scored <90/100 on the French MBAA2 Sentence Recognition Test in Quiet at 1 month post activation. There is therefore no posted estimate of the proportion in either category, and no basis in the record for describing the observed distribution of performance.
The record lists 32 participants enrolled, 1 outcome measure and 0 analysis entries. Enrollment alone does not show how many participants had an available endpoint measurement. The number with missing or unevaluable scores is not reported in the registry record. Without outcome counts and a denominator for the endpoint, neither the category frequencies nor their precision can be assessed from the registry record.
The stated aim concerns relationships between audiometric, cognitive and electrophysiological results and sentence recognition scores. Those domains are mentioned in the study summary, but the record does not report their measurements, associations, estimates, or uncertainty. It is therefore not possible to determine from the posted results whether any relationship was observed, how large it might have been, or how precisely it was estimated. No statistical tests, confidence intervals, or other inferential results are reported.
The outcome is a binary classification based on a stated cutoff, rather than a reported continuous score. Even if the two category counts were available, they would describe the classification, not the full range of test scores. In general, a confidence interval expresses uncertainty around an estimate; no such interval for this endpoint is reported in the registry record. The registry’s completion status does not substitute for posted results, and should not be read as evidence for any particular outcome.
The study is not a randomized comparison, and the registry warns that any arms are not a like-for-like control comparison. No treatment-effect contrast can be interpreted from the information recorded. The available information supports a description of the study objective, cohort context, endpoint definition and reporting gaps, but not a conclusion about performance levels or associations among the named domains.
9. Statistical Methods Explained
What does a binary endpoint represent?
A binary endpoint places each participant into one of two categories. In this study, the categories are good performer and bad performer, defined by whether the French MBAA2 Sentence Recognition Test in Quiet score meets the registry’s cutoff of ≥90/100 correct sentence or is <90/100 correct sentence. A count for each category, together with the number of participants assessed, would allow the category frequencies to be described. Those counts are not reported in the registry record.
Binary classification can simplify communication when the scientific question concerns a particular threshold. It also removes information from the original measurement. Scores within a category are treated alike even though they may differ, and scores close to opposite sides of a cutoff are placed in separate groups. The registry does not report the underlying test scores or the rationale for selecting this cutoff, so the impact of categorization on the interpretation cannot be assessed.
How would uncertainty be described?
In general, an estimate based on a sample is subject to uncertainty because another sample could yield a different result. A confidence interval is a way to express the range of values reasonably compatible with the observed data under a specified statistical method. For a binary outcome, uncertainty depends on the observed category counts and the number assessed. Since neither the endpoint counts nor an interval estimate is posted, the precision of the primary outcome is not available for evaluation.
For association questions, analysis would also require a clear definition of the measurements being related, an estimate of the association, and a description of uncertainty. The summary names audiometric, cognitive and electrophysiological results as domains of interest, but the registry does not report the specific measures, analytical methods, estimates or uncertainty. The record contains no analysis entries, and the statistical plan is not reported in the registry record. It would therefore be inappropriate to attribute any particular test, model, adjustment strategy or hypothesis to the investigators.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability in count data exceeds what a chosen statistical model expects. If over-dispersion is present and ignored, estimated uncertainty can be too small, making results appear more precise than the data support. This concept is relevant to some analyses of counts, but the primary outcome in this record is described as a count of participants classified into categories. The registry reports neither an analysis model nor results that would establish whether over-dispersion was assessed or relevant. No conclusion about its presence can be drawn for this study.
How should planning calculations be read?
Any sample-size figures associated with planning are illustrations rather than observed study results or evidence of the study’s design. The stated planning assumptions use a two-sided significance level of 0.05, equal allocation between two arms and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. The record identifies these as planning illustrations, not the trial’s own design. It also states that time-to-event calculations use total events and other calculations use participants per arm. These conventions do not establish that this non-interventional feasibility study used a two-arm design or that such calculations were part of its protocol. A planning calculation is not observed power and cannot fill in missing endpoint results.
In general, a statistical analysis plan specifies how outcomes and comparisons will be analyzed, including how estimates and uncertainty will be presented. Such a plan can clarify how the investigators intended to handle the data before results are known. The registry record does not report that plan, the method used for the primary endpoint, or the methods used for the stated association questions. The statistical methods that were actually used are therefore not identifiable from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 1 outcome measure and 0 analysis entries. A single listed outcome does not establish that the full study considered only one question or performed only one analysis; the registry’s summary also describes an interest in relationships involving audiometric, cognitive and electrophysiological results. The analysis plan and any approach to multiple comparisons are not reported in the registry record. Without those details, it is not possible to determine whether multiplicity was relevant to the analyses or how it was handled.
Missing-data procedures are also not reported in the registry record. The record does not state how many enrolled participants had an evaluable sentence-recognition score at 1 month post activation, whether any measurements were missing, or whether any imputation or other missing-data method was used. Enrollment of 32 is not by itself an endpoint denominator. Without the number assessed and the handling of missing observations, the completeness of the endpoint data cannot be evaluated.
The population used for analysis is not specified in the registry record. The primary outcome description identifies the participant categories, but it does not define an analysis population or explain exclusions. No details are reported about how unavailable scores, participants with incomplete measurements, or other data issues would be addressed. These gaps limit reproducibility and make it difficult to judge whether any eventual estimate would describe all enrolled participants or a subset.
11. What the Result Does, and Does Not, Mean
The registry record supports a narrow interpretation: the study was designed as a non-interventional feasibility study, and its primary endpoint was a binary classification of sentence recognition performance at 1 month post activation. The record names the French MBAA2 Sentence Recognition Test in Quiet and defines the cutoff for good and bad performance. It also states an aim of examining relationships between audiometric, cognitive and electrophysiological results and sentence recognition scores.
The record does not report the endpoint counts, underlying scores, associations, statistical estimates or uncertainty. It cannot establish the observed proportion of participants in either performance category, how participants’ results varied, or whether the named domains were related to sentence recognition. The completed status does not provide those results. Nor does the record support a causal comparison: the study is non-interventional, no comparator is specified, and the record cautions that any arms are not a like-for-like control comparison.
In general, a threshold-based outcome describes whether participants fall on one side or the other of a cutoff; it does not describe all the information contained in individual scores. A reported category count could address how many meet the definition, but would not by itself establish why scores differ or whether a particular factor caused a difference. The absence of posted results is not evidence that an association was absent, and it is not evidence that the endpoint was uniformly high or low. Any interpretation of the study’s findings must await results and methods that are not reported in the registry record.
12. Why This Trial Matters Statistically
This study is statistically notable for the contrast between a specific measurement question and the limited results recorded in the registry. The endpoint is defined in operational terms: participants are classified using a cutoff on a sentence-recognition test at a stated time after activation. A clear operational definition is important because it makes the intended outcome understandable and potentially reproducible. However, an outcome definition alone does not reveal the observed distribution or the precision of an estimate.
The study aim spans several domains— audiometric, cognitive and electrophysiological results—and asks how they relate to sentence recognition. Such questions require clear definitions of the measures and transparent reporting of estimates and uncertainty. The registry record does not provide those details or any analysis entries. As a result, it is possible to understand the intended broad question but not to evaluate the strength or precision of any association.
The record also illustrates why study design and analysis must be distinguished. The study is described as non-interventional, and no like-for-like control comparison is established. Planning illustrations based on equal allocation between two arms are explicitly not the study’s design. Keeping that distinction clear prevents planning calculations from being mistaken for observed evidence or for proof of a comparison that the record does not document. The study’s statistical contribution cannot be assessed from the registry entry alone because outcome results and analysis details are not reported.
13. 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 leaves important features of this specific study undescribed. It lists adults currently using a Nucleus cochlear implant and bilateral sensorineural hearing loss, but detailed eligibility criteria, participant characteristics, recruitment procedures and the distribution of participants across any groups are not reported in the registry record. The enrollment figure does not show how many participants contributed data to the primary endpoint.
The primary outcome is defined at 1 month post activation, but the record does not describe the timing or completeness of the test assessments, the underlying score distribution, or any procedures for handling unavailable measurements. The rationale for the ≥90/100 cutoff is not reported in the registry record. Because results are not posted, it is also not possible to judge whether the endpoint categories were balanced or whether the threshold captured meaningful variation in participants’ scores.
The study’s stated interest in audiometric, cognitive and electrophysiological results is not accompanied by named measures, analysis methods or association estimates. The statistical plan, analysis population and multiplicity procedures are not reported in the registry record. The non-interventional design and lack of a specified comparator also limit interpretation of any potential between-group differences; the record itself cautions that arms are not a like-for-like control comparison. These are limitations of what can be evaluated from the registry record, not evidence that a particular result or procedure was absent from the study itself.
14. Related Tutorials
15. Related Statistical Calculators
16. Sources
- ClinicalTrials.gov: Factors Affecting Early Progress of Cochlear Implant Outcomes in Adults — NCT05265260.
- Registry record last updated 2024-04-05; status last verified 2023-10.
- Results first posted 2024-04-05.
- 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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17. Record Summary
NCT05265260 is a completed non-interventional feasibility study sponsored by Cochlear. The registry lists enrollment of 32 and bilateral sensorineural hearing loss as the condition. The study concerns adults currently using a Nucleus cochlear implant and aims to understand how audiometric, cognitive and electrophysiological results relate to sentence recognition scores.
The primary outcome is the count of participants classified as good or bad performers on the French MBAA2 Sentence Recognition Test in Quiet at 1 month post activation. The threshold is ≥90/100 correct sentence for good performance and <90/100 for bad performance. The registry lists 1 outcome measure and 0 analysis entries. It does not report outcome counts, statistical estimates, missing-data procedures or the analysis plan. No randomized comparison is described, and the registry cautions that any arms are not a like-for-like control comparison.