Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder (NCT02353091), a randomized na study. The primary outcome is Listening Inventory For Education Revised (LIFE-R) - Total Score.

2. Clinical Question

The study asks whether children diagnosed with auditory processing disorder have different listening outcomes after using remote microphone hearing aids than children in a control group without an intervention. The primary outcome is the Listening Inventory For Education Revised total score, a child questionnaire measure of classroom listening. The registry describes its timeframe as baseline to 6 months.

The intervention group received remote microphone hearing aids after baseline testing and used them for 6 months. The control group did not use an intervention. The study was randomized, but masking was listed as none. The registry describes the groups as parallel, meaning the participants were assigned to one group rather than moving between interventions.

The study description also asks whether the devices affect listening in noise, listening in spatialised noise, and auditory attention. Its stated hypotheses anticipated improved classroom listening and speech-in-noise skills after 6 months of device use, while spatialised-noise listening and attention would remain unchanged. These are hypotheses, not reported findings. The listed secondary outcomes include auditory attention measures; the registry record does not provide results for them.

The central statistical question is therefore whether the posted data support a difference in the primary classroom-listening score between the groups over the stated timeframe, and how precisely that difference is estimated. The registry record does not report a numerical comparison, uncertainty interval, or test result for the primary outcome. It consequently does not establish the direction or size of any group difference.

3. Trial Design

The registry describes a completed, randomized, parallel-group study with no masking. The condition was auditory processing disorder, and the intervention was a device: remote microphone hearing aids. The study description says children aged 7-12 with an auditory processing disorder diagnosis were included. It identifies the Great Ormond Street Hospital Audiology clinic as the recruitment setting.

The enrollment entry is 26. The arm descriptions list 13 children in the APD Control Group and 13 in the APD Intervention Group. The control group received no intervention. The intervention group received the devices after baseline testing and used them for 6 months. These are the registry's group descriptions; the record does not provide further detail about adherence, device use between visits, or how group assignment was generated.

The primary outcome timeframe is baseline to 6 months. The study description also refers to hypotheses about listening in noise, spatialised-noise listening, and attention. Four secondary attention outcomes are named, covering sustained auditory attention, divided auditory-visual attention, selective visual attention, and divided auditory attention.

The sponsor is University College, London. The recorded start is 2016-05, primary completion is 2017-09, and status is completed. The registry record does not report the randomization method, allocation concealment, masking procedures beyond the entry of none, visit schedule, or treatment fidelity. It also does not report a detailed protocol or statistical analysis plan. Those omissions limit what can be inferred about the conduct and analysis beyond the design features explicitly recorded.

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

Analysis population for the primary outcome, as defined in the registry: An outlier at the 3-month time-point (at -3.25 SDs) was removed

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 Listening Inventory For Education Revised (LIFE-R) - Total Score, measured over Baseline to 6 months.

The primary endpoint is the Listening Inventory For Education Revised (LIFE-R) total score, measured in units on a scale. The registry describes it as a child questionnaire made up of 9 questions, each rated on a likert scale from 0 to 5. The answers are summed, giving a possible score from 0 to 45. Higher scores mean a better outcome.

This measure was selected as the primary outcome for a study focused on classroom listening. Its questionnaire format captures the child's reported listening experience rather than a laboratory measure alone. In general, a prespecified primary endpoint gives a trial a central outcome to assess, helping distinguish its main question from additional outcomes that may also be of interest. The registry record identifies this score as primary but does not explain the selection process or report evidence about the measure's reliability or validity in this study.

The stated timeframe is baseline to 6 months, corresponding to the intervention period described for the device group. However, the registry record does not give group means, standard deviations, a between-group estimate, a confidence interval, or a statistical test for this endpoint. It therefore does not report how the score changed in either group or how the groups compared. The record notes that an outlier at the 3-month time-point, described as at -3.25 SDs, was removed. It does not explain the removal rule or report how that decision affected the primary comparison.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the study as randomized, unmasked, and parallel-group. Randomization is intended, in general, to make group assignment independent of participants' measured and unmeasured characteristics on average. It does not guarantee that groups will be identical, particularly in a modest study, and the registry record does not describe the assignment sequence or concealment procedures. The entry of no masking means the study was not recorded as masked; the record does not provide further information about who knew group assignments or whether outcome assessment was masked.

A parallel-group design compares participants assigned to different groups over the study period. Here, the recorded comparison is between children receiving remote microphone hearing aids and children in a control group without an intervention. The intervention group used the devices for 6 months after baseline testing. The endpoint timeframe is baseline to 6 months. The registry does not report the statistical model used to account for baseline scores or repeated measurements, so it is not possible to identify whether the primary analysis compared follow-up scores, changes from baseline, or another contrast.

The LIFE-R total score is described as a continuous measure summarized by a mean and standard deviation. In general, a mean describes the average score, while a standard deviation describes how spread out individual scores are around that average. The registry labels the primary parameter as a mean and the dispersion measure as a standard deviation, but does not provide the corresponding values for either group. A mean difference could be used to express a contrast on the scale's units, but no such estimate is reported in the registry record.

In general, a confidence interval communicates uncertainty around an estimate, with wider intervals indicating less precision under the chosen method. It is useful to consider both the estimated magnitude and interval rather than relying on a significance threshold alone. The registry record does not report a confidence interval or describe the method used to calculate one. It also does not report a test statistic or p-value for the primary endpoint.

The record describes a planning illustration based on a fraction of an observed effect. Its stated assumptions are a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. Such illustrations are planning scenarios, not outcomes observed in the trial and not estimates of the probability that a result is true. The registry record does not report the numerical planning results or a sample-size justification used for the trial's design. It is therefore not possible to assess whether the enrolled study was planned around a particular target effect using the available record.

The record notes that an outlier at the 3-month time-point, at -3.25 SDs, was removed. In general, an outlier can have a strong influence on a mean and on methods that assume a particular distribution. Removing an observation may reduce that influence, but can also change the estimate and its uncertainty. The record does not report the rule used to identify the observation, whether the rule was prespecified, the reason for removal, or a sensitivity analysis retaining it. The note does not establish whether the primary 6-month comparison was affected.

Over-dispersion is a general concern when the observed variability is greater than a model assumes; if ignored, uncertainty estimates can be too small. It is not possible to assess over-dispersion in this study from the registry record because the outcome distributions and analysis model are not reported. Likewise, the record does not state whether assumptions were checked or whether an alternative model was used.

Multiplicity arises when many outcomes, time points, or comparisons are examined. In general, a larger family of tests can increase the chance of at least one apparently notable result, so a prespecified analysis plan may define a primary comparison or a method for accounting for multiple tests. The record lists 17 outcome measures and zero analyses, and says the primary outcome has several categories or time points and was not reduced to one comparison. It does not report a multiplicity strategy or identify which contrasts, if any, were treated as confirmatory.

These general explanations do not identify the method used in this trial. The registry record does not report a detailed statistical analysis plan, missing-data method, analysis population, model specification, covariate adjustment, or method for handling repeated measurements. No recalculated treatment estimate is reported, so there is no recalculation to compare with a sponsor analysis.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists 17 outcome measures and zero analyses. The study description names questions about classroom listening, listening in noise, spatialised-noise listening, and auditory attention, while the secondary outcomes include four attention subscales. Examining multiple outcomes or time points can complicate interpretation: in general, the more comparisons considered, the greater the chance that an apparently notable finding occurs by chance. The registry record does not report a method for addressing multiplicity, identify a hierarchy among secondary outcomes, or specify which comparisons were planned as confirmatory.

The record also says the primary outcome has several categories or time points and was not reduced to one comparison. No single numerical primary comparison is reported. The registry does not report whether analyses were planned for each time point separately or how any repeated measurements were to be handled. The sample-size planning assumptions do not resolve these questions, and numerical planning results are not reported.

Missing-data handling is not reported in the registry record. There is no description of the amount or pattern of missing outcome data, any imputation approach, or how participants with incomplete measurements were treated. The analysis population is also not reported: the record does not specify whether analyses followed assigned groups, included only participants with available measurements, or used another population definition.

The registry notes removal of an outlier at the 3-month time-point, at -3.25 SDs, but does not state whether other observations were missing or how the removed observation was treated in analyses at other time points. Without a reported analysis plan and outcome results, the influence of missing data, multiplicity, and the outlier decision cannot be assessed.

11. 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 0% reporting threshold.

The registry reports serious adverse event figures separately for the APD Control Group and the APD Intervention Group. For each group, 13 participants are listed as at risk and 0 as affected by serious adverse events. The record lists 0 deaths in each group. It also lists 13 at risk and 0 affected for other adverse events in each group.

These are the figures recorded for the trial, not a complete description of how safety was monitored. The registry does not report the observation period for adverse events, definitions used, collection procedures, or whether events were actively solicited. It also does not provide details of specific non-serious events; the serious-event terms list is empty.

A count of zero recorded events does not establish that the intervention has no risks. It describes what the registry lists during the reporting period, whose duration and methods are not given. The figures also do not provide a precise estimate of how often an event might occur outside this study. In general, safety interpretation depends on the number of participants monitored, the duration and completeness of follow-up, and the consistency of event ascertainment. The registry record does not provide enough detail to assess those features beyond the at-risk and affected counts.

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

The record describes a randomized comparison of remote microphone hearing aids with no intervention in children diagnosed with auditory processing disorder. It identifies classroom listening, measured by the LIFE-R total score, as the primary outcome and gives a baseline-to-6-month timeframe. It also records the intervention duration and the groups' descriptions. These details clarify the question the study was designed to address.

They do not establish whether the groups differed. The registry record does not report primary-outcome means, a treatment contrast, a confidence interval, or a p-value. It also does not report numerical results for the listening, spatialised-noise, or auditory-attention outcomes named in the study description. The investigators' stated hypotheses should not be treated as observed results. On the available record, neither improvement nor absence of improvement can be concluded.

Even if a numerical difference were available, its interpretation would depend on uncertainty, the scale's meaning, the analysis population, missing-data handling, and the effects of examining multiple outcomes or time points. Those details are not reported in the registry record. The outlier note adds another consideration, but the record does not describe its influence or provide an analysis retaining the observation.

The recorded safety counts show no serious adverse events, other adverse events, or deaths listed as affecting participants in either group. Those counts describe the registry entry; they do not establish absence of risk, particularly because the monitoring period and collection methods are not reported.

Accordingly, the registry record supports a description of the design, endpoint, and recorded adverse-event counts, but not a conclusion about the effect of the devices. A completed trial status indicates that the study is recorded as completed; it does not fill the gap in posted outcome analyses.

13. Why This Trial Matters Statistically

This study is statistically notable as a randomized comparison centered on a patient-reported classroom-listening score in children with auditory processing disorder. The primary endpoint is defined as a summed questionnaire score, and the record states which direction represents a better outcome. These details make the outcome's scale and intended interpretation explicit.

The record also illustrates why design information and findings need to be distinguished. Randomization, parallel groups, and a specified endpoint describe how a study was structured. They do not reveal the observed difference or the precision of that difference. Without group summaries and an inferential comparison, readers cannot judge whether the posted data are compatible with a meaningful benefit, little difference, or another pattern.

Multiplicity is relevant because the study description raises questions across multiple listening and attention domains, while the record lists 17 outcome measures and does not report an analysis. A clear account of which endpoint and contrast are primary, how additional outcomes are interpreted, and how missing observations are handled helps readers distinguish planned evidence from exploratory findings. Those details are not reported in the registry record.

The outlier note also matters statistically. A removed observation can affect estimates, especially for a mean-based outcome, and transparent reporting of the decision and sensitivity checks helps readers understand whether conclusions depend on it. The registry identifies the time point and standardized distance but does not provide that context or a comparison with the observation retained.

Finally, the registry's zero-event safety counts should be read alongside its lack of monitoring details. This record therefore offers useful design and endpoint information, while leaving the central efficacy and precision questions unanswered. That distinction is important for evidence appraisal: a well-defined research question is not itself a reported treatment result.

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 for interpreting this trial from the registry record is the absence of numerical outcome analyses. Although the study is recorded as completed and the primary endpoint is identified, no group-level scores, between-group estimate, confidence interval, or p-value is reported. The record also lists zero analyses. Consequently, the size, direction, and precision of the primary comparison cannot be assessed.

Important analysis details are not reported in the registry record, including the randomization method, allocation concealment, statistical model, analysis population, missing-data strategy, and handling of repeated measurements. The record does not explain how multiplicity was addressed despite listing 17 outcome measures and multiple outcome domains. It also does not report a detailed statistical analysis plan or the numerical results of its sample-size planning illustration.

The registry notes that an outlier at the 3-month time-point, at -3.25 SDs, was removed. It does not state the decision rule, whether removal was planned, the reason for removal, or whether results were checked with that observation retained. This makes the potential effect of the exclusion difficult to judge.

The entry of no masking may allow participants or study personnel to know group assignments, but the registry does not describe who was aware of assignment or how outcomes were collected. Details about device adherence and treatment fidelity are also not reported. For safety, the record gives affected and at-risk counts but not the monitoring period, event definitions, or ascertainment method. These limitations concern what can be learned from the registry record; they do not establish that the trial itself lacked such procedures.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Effects of Remote Microphone Hearing Aids on Children With Auditory Processing Disorder — NCT02353091.
• Registry record last updated 2020-05-05; status last verified 2020-03.
• Results first posted 2020-04-27.
• 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.

18. Record Summary

The registry record describes a completed randomized, unmasked, parallel-group study of remote microphone hearing aids in children diagnosed with auditory processing disorder. Enrollment is listed as 26. The arm descriptions identify 13 children in the control group without an intervention and 13 in the intervention group, which used the devices for 6 months after baseline testing.

The primary endpoint is the LIFE-R total score, a summed child questionnaire measure of classroom listening, with higher scores indicating a better outcome. Its timeframe is baseline to 6 months. The record notes removal of an outlier at the 3-month time-point. It names additional questions and auditory-attention outcomes, but does not report numerical outcome analyses. The record lists zero analyses and does not provide a primary treatment comparison, uncertainty interval, or p-value.

Serious adverse events, other adverse events, and deaths are listed as affecting 0 participants in each group. The safety monitoring period and methods are not reported in the registry record.