Treating Hearing Loss to Improve Mood and Cognition in Older Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treating Hearing Loss to Improve Mood and Cognition in Older Adults (NCT03321006), a randomized phase 4 study. The primary outcome is Hamilton Rating Score for Depression (HRSD).

2. Clinical Question

The registry record describes a trial in older adults with hearing loss and depression, comparing full-amplification hearing aids with low-amplification sham hearing aids. Participants in both groups also received escitalopram or duloxetine. The clinical question was whether adding full amplification, rather than sham amplification, was associated with a different clinician-rated depression score at 12 weeks.

The trial’s primary measure was the Hamilton Rating Score for Depression (HRSD). The posted comparison is between the mean score for the full-amplification group and the mean score for the sham group. It therefore concerns the contrast between hearing-aid conditions in the setting of antidepressant treatment. It is not a comparison of antidepressant treatment with no antidepressant treatment, and it does not isolate the effect of either escitalopram or duloxetine.

The broader rationale in the registry record concerns age-related hearing loss, social isolation, and late-life depression. The record describes the hypothesis that untreated hearing loss may be a route to late-life depression and notes interest in whether treating hearing loss could affect depressive symptoms. Those statements explain the motivation for the trial; they are not themselves findings from this randomized comparison.

Eligibility details beyond the stated conditions and the described study population are not reported in the registry record. In particular, the exact criteria used to define hearing loss or depression, and the characteristics of participants who entered the trial, are not reported in the registry record. The result should therefore be read as an estimate from the participants represented in the posted outcome data, rather than as a result that necessarily applies to every older adult with hearing loss or depression.

3. Trial Design

This was a randomized, quadruple-masked, parallel-group Phase 4 trial. The registry record lists an enrollment of 25 and a completed status. The study start was 2018-05-30 and primary completion was 2021-05-31. The sponsor was New York State Psychiatric Institute.

The two described groups received the same general antidepressant options—escitalopram or duloxetine—but differed in hearing-aid amplification. One group received full amplification with an active hearing aid; the other received low amplification with a sham hearing aid. The registry describes treatment for 12 weeks. The primary outcome was also assessed at 12 weeks.

Random allocation is intended to make the groups comparable on average at the start of a trial, while masking is intended to limit influences from knowledge of group assignment. The registry identifies the allocation as randomized and the masking as quadruple, but does not report the specific randomization procedure, who was masked, how masking was maintained, or whether masking was assessed. Those design details are not reported in the registry record.

The primary outcome data list 12 participants in the sham group and 11 in the full-amplification group. These are the group counts attached to that outcome, not a reconciliation of every enrollment, treatment, or safety count. The record’s adverse-event counts use different at-risk group sizes. Reasons for differences between outcome counts, enrollment, and safety counts are not reported in the registry record.

The registry does not report the original sample-size justification, the trial’s planned statistical analysis, or whether interim analyses were conducted. The planning illustrations associated with the posted results are separate from the trial’s original design assumptions.

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

Reasons for not completing this period:

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 Hamilton Rating Score for Depression (HRSD), measured over 12 weeks.

The primary endpoint was the Hamilton Rating Score for Depression (HRSD) at 12 weeks. It is a clinician-rated measure: a clinician rates the patient across the 24 dimensions of the 24-item HRSD. The registry describes scores on a 3- or 5-point scale and a maximum score of 74. It identifies scores from 0-7 as normal, 8-16 as suggesting mild depression, 17-23 as moderate depression, and scores over 24 as indicative of severe depression.

A continuous score preserves gradations across participants rather than reducing each result to a category. Comparing group means can therefore describe the average difference in the recorded scale scores, while the individual score ranges give context for what the scale is intended to capture. A group mean does not show how many participants fell into each severity category, nor does it describe the full spread of individual scores. Such category counts and participant-level distributions are not reported in the registry record.

Clinician rating makes the endpoint a structured assessment rather than a direct self-report. It is used to quantify depressive symptom severity over the study period. The posted result is a comparison of group means at the stated assessment time; it does not, by itself, show each participant’s change from baseline. Baseline HRSD values and a change-from-baseline analysis are not reported in the registry record.

The endpoint is relevant to the trial’s stated depression question, but its interpretation depends on the measurement and analysis details. The registry does not report how assessments were scheduled within the 12-week period, how missing endpoint values were handled, or whether the primary comparison was adjusted for baseline score.

7. Results Posted in the Registry

• Antidepressant (AD) + Full Amplification Hearing Aids: mean 13.86 versus 12.04 on control; difference 1.82 (95% CI -2.88 to 6.52), standardized effect d = 0.32; z-test p = 0.448.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Clinical Global Impression Severity and Improvement (CGI)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Antidepressant (AD) + Full Amplification Hearing Aids: mean 3.20 versus 3.17 on control; difference 0.03 (95% CI -0.88 to 0.94), standardized effect d = 0.03; z-test p = 0.949.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Antidepressant (AD) + Full Amplification Hearing Aids and the control. The interval gives the range of effects that remain compatible with the data.

Social Adjustment Scale Self-Report (SAS-SR) Score

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • Antidepressant (AD) + Full Amplification Hearing Aids: mean 2.10 versus 1.96 on control; difference 0.14 (95% CI -0.21 to 0.49), standardized effect d = 0.34; z-test p = 0.429.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Antidepressant (AD) + Full Amplification Hearing Aids and the control. The interval gives the range of effects that remain compatible with the data.

The two posted secondary outcomes address related but distinct aspects of participants’ status: clinical global impression and social adjustment. Their estimates do not present a consistent basis for a firm claim that the amplification groups differed. As with the primary endpoint, the comparisons are based on group means and have uncertainty around them. The overall pattern should be considered alongside the primary HRSD result, not as an independent confirmation of a clear treatment contrast.

These measures may add context because depression severity, a clinician’s overall impression, and social adjustment are not interchangeable constructs. Agreement across different measures can sometimes strengthen a coherent interpretation, while disagreement may reflect differences in what each measure captures. In this record, the secondary comparisons do not remove the uncertainty in the primary result or establish a distinct effect on another outcome.

The registry lists unadjusted p-values for these comparisons and does not list reported analyses. It does not report a multiplicity adjustment, a hierarchy of outcomes, or a prespecified strategy for interpreting secondary endpoints. When multiple outcomes are examined, the chance of obtaining an apparently notable result can increase unless the analysis accounts for that multiplicity. This is a general statistical concern; the record does not state whether an unreported plan existed.

Accordingly, secondary outcomes should carry less weight than a prespecified primary endpoint, particularly when the analysis plan and multiplicity approach are not reported. They can be viewed as descriptive or exploratory evidence, but the registry information does not justify treating them as definitive tests of separate hypotheses. They also cannot compensate for limited precision in the primary estimate or establish effects beyond the specific measures and assessment time listed.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Clinical Global Impression Severity and Improvement (CGI)
• Social Adjustment Scale Self-Report (SAS-SR) Score

9. Statistical Interpretation

10. Statistical Methods Explained

The primary result is a comparison of means for a continuous outcome. A mean is the arithmetic average of the recorded scores in a group. The reported estimate is the full-amplification mean minus the sham-group mean, so a positive value indicates a higher score in the full-amplification group on the recorded scale. The posted values are means at 12 weeks, not reported changes from baseline.

What does the standard error describe?

The registry reports standard errors alongside the group means. A standard error describes the uncertainty in an estimated mean due to sampling variation under the statistical model; it is not the spread of individual participant scores. The standard errors are 1.72 for the sham group and 1.67 for the full-amplification group. A standard error can help characterize precision, but it does not show the full distribution of observed scores. The registry does not also report group standard deviations for the primary outcome as direct summary values.

For a continuous measure, the uncertainty in a difference between means depends on the uncertainty in each group mean and on the analysis assumptions. The posted comparison includes a pooled standard deviation of 5.762 and a standardized difference of 0.316. A pooled standard deviation combines information about spread across groups for a standardized comparison. A standardized difference expresses the mean contrast relative to that pooled spread; it is useful for comparing effect scales, but it is not an additional clinical outcome and does not replace the score-unit difference.

How should the p-value be read?

The unadjusted p-value is 0.448. In general, a p-value describes how compatible the observed data, or data more extreme, are with a specified null model if that model and its assumptions hold. It is not the probability that the null hypothesis is true, and it does not measure the probability that the observed difference occurred by chance. The word “unadjusted” matters: the registry does not report a correction for testing multiple outcomes or comparisons. The p-value should therefore be read as an unadjusted result, not as a multiplicity-controlled finding.

The registry record does not report the test used to calculate the comparison, the model specification, or whether covariates were included. A simple unadjusted comparison of means is one possible approach, but it should not be asserted as the trial’s actual analysis without a reported statistical plan. The posted estimates can be described as group summaries and a mean contrast; the precise analysis procedure is not reported in the registry record.

Why does the confidence interval matter?

A confidence interval presents a range of values that are compatible with the data and the method used to construct the interval. It conveys uncertainty around the estimated contrast, rather than only indicating whether a test crossed a threshold. For this result, the interval extends from -2.879 to 6.519. Since it includes zero and values on either side, it does not identify a single direction or a narrow magnitude for the group difference. The confidence level and exact interval construction are not reported in the registry record, so those details should not be inferred.

In general, uncertainty is affected by the amount of information and the variability in the outcome. Small outcome groups and variable measurements tend to make estimates less precise. This is a general statistical explanation; the record does not report a trial-specific variance model or the rationale for its sample size.

What do the planning illustrations represent?

The accompanying sample-size planning uses a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers effects equal to the observed effect and stated fractions of it. The figures are participants per arm, not total events. Such calculations illustrate the sample size that would be needed under those assumptions to target a chosen probability of detecting a specified effect if it were present. They are not the trial’s original design calculation, and the registry’s original design assumptions are not reported.

The planning estimates use the observed effect as their reference. Because an observed effect from a small study can be unstable, these illustrations should not be treated as reliable forecasts of a future trial’s true effect. A planning exercise based on a different target effect, variability assumption, analysis method, or allocation would yield different requirements. The registry does not report whether the original trial used these assumptions.

What analysis details remain unknown?

The registry does not report the primary analysis population, handling of missing outcome data, adjustment for baseline HRSD, adherence-based analyses, or protocol deviations. It also does not report a trial statistical analysis plan, or the exact method used to calculate the confidence interval and p-value. These omissions limit assessment of how closely the posted estimates reflect a prespecified analysis and how sensitive they might be to analytic choices.

11. Confidence Intervals and Precision

The primary mean difference was 1.82 points, with a confidence interval from -2.879 to 6.519. The interval is wide enough to include zero and values in both directions. It therefore does not pin down whether the full-amplification group had a lower or higher mean HRSD score than the sham group in the population represented by the comparison. The point estimate is only one value within a broader range of estimates compatible with the data and interval method.

Precision is distinct from statistical significance and from clinical importance. A confidence interval that includes zero does not prove that there is no difference. Conversely, the point estimate alone does not show that there is a meaningful difference. The registry does not report a threshold for a clinically important HRSD difference, so the clinical relevance of the range cannot be judged against a trial-defined criterion.

The outcome-specific counts are 12 for sham and 11 for full amplification. These counts, together with the observed variability, help explain why the estimate may be uncertain, but the registry does not report a detailed precision analysis or the intended detectable effect for the original trial. The standard errors for the group means were 1.72 and 1.67, respectively. They quantify uncertainty around the means, not the range of individual participant scores.

The confidence level and construction method for the posted interval are not reported in the registry record. The interval should be interpreted as the posted uncertainty range without assigning an unreported confidence level. Overall, the posted data support a broad range of possible mean contrasts rather than a precise estimate.

12. Planning a Similar Trial: Sample Size

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

The planning figures are participants per arm. They are not total event counts: this is a continuous-outcome comparison, and the stated planning assumptions specify equal allocation between two arms. The registry’s planning illustration uses a two-sided significance level of 0.05 and a normal approximation. Its effects to detect are expressed as the observed effect, 75% of the observed effect, and 50% of the observed effect.

The 80% power column describes the number of participants per arm that the planning calculation estimates would give an 80% chance of detecting the specified effect under the calculation’s assumptions, if that effect were present. The 90% power column gives the corresponding planning target for a 90% chance. These are design probabilities under assumptions, not guarantees for a particular future study. The registry’s original sample-size assumptions and justification are not reported.

For the primary outcome, the planning estimates rise as the assumed effect becomes smaller. The same pattern appears in the secondary-outcome planning illustrations: detecting a smaller fraction of the observed effect requires more participants per arm under these assumptions. This is a general feature of power calculations: smaller target differences are harder to distinguish from sampling variation, so more information is needed.

These calculations are planning illustrations based on the observed effect, not observed power. They should not be read as a retrospective measure of how likely the completed trial was to detect an effect, nor as evidence that a future study will achieve its target. The observed effect may not represent the effect a future study should target, and different assumptions can change the planning estimates.

13. How the Sample Size Is Derived

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

Formula

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

Worked calculation for this trial

1. Observed difference Δ = 1.820; pooled standard deviation σ = 5.762.
2. n = 2 × (1.96 + 0.842)² × 5.762² / 1.820² = 157.4, rounded up to 158 participants per arm for 80% power.

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

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- 1.82                      # observed difference in means
sigma <- 5.76230691237294                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

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

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3321006)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 158 (80% power), 211 (90% power)
 75% of observed effect: n per arm = 280 (80% power), 375 (90% power)
 50% of observed effect: n per arm = 630 (80% power), 843 (90% power)
power.t.test: 158.3 
Simulated power at n = 158 per arm: 0.799 (20000 replicates)

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

14. Multiplicity, Missing Data and Analysis Populations

The registry identifies an HRSD primary outcome and lists clinical global impression and social adjustment as secondary outcomes. It does not report a statistical analysis plan, a testing hierarchy, or a method for controlling the chance of false-positive findings across outcomes. The posted p-values are unadjusted. Without a reported multiplicity strategy, secondary comparisons should be interpreted cautiously, and a nominal result should not automatically be treated as confirmatory.

Missing-data handling is also not reported in the registry record. The primary endpoint counts are 12 in the sham group and 11 in the full-amplification group, while the secondary outcome counts are 11 in each group. The record does not explain why the counts differ, whether observations were unavailable, or how any missing values were treated. It does not state whether the estimates use all randomized participants, only participants with observed outcomes, or another analysis population.

The registry does not report whether participants were analyzed according to randomized group assignment, whether adherence or treatment received affected inclusion, or whether participants who discontinued treatment remained in the analysis. These distinctions matter because excluding participants or using different analysis populations can affect the comparison and its interpretation. No assumptions about those procedures can be made from the posted record.

Baseline HRSD scores, baseline adjustment, and the handling of protocol deviations are not reported. Nor are sensitivity analyses described. These details would help assess whether conclusions depend on analytic choices, but their absence from the registry record does not prove that no such work was done. It means the posted record does not document it. With no reported multiplicity plan, missing-data method, or analysis population, the comparisons are best interpreted as the posted outcome summaries and estimates, with these methodological uncertainties in view.

15. 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.

Most frequent serious adverse event terms

Serious events with the highest arm-level rate: serious adverse event (9.1%), all cause mortality (7.1%).

The safety record lists serious adverse events affecting 1 participant in the sham group, among 14 at risk, and 1 participant in the full-amplification group, among 11 at risk. It records 1 death in the sham group and 0 in the full-amplification group. These are the registry’s reported counts; they should not be treated as proof that an event was caused by a hearing aid or an antidepressant.

The at-risk counts differ from the primary outcome counts. The registry does not explain the difference, define the relationship between the event categories, or provide event-level details in the posted information. The listed terms include Serious Adverse Event at 9.1% and All Cause Mortality at 7.1%. Those labels should be read as the record’s safety classifications, not as estimates of comparative risk derived from a statistical analysis.

The groups are small, and the record does not report a comparative safety analysis, uncertainty intervals, or attribution of events to specific treatments. The counts therefore describe what was recorded in each group but do not support a precise conclusion about relative safety.

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

The posted result is a comparison of mean clinician-rated depression scores at 12 weeks between participants assigned to full-amplification hearing aids and those assigned to low-amplification sham hearing aids, with both groups also receiving escitalopram or duloxetine. The observed mean difference was 1.82 points, with a confidence interval from -2.879 to 6.519 and an unadjusted p-value of 0.448. The interval includes zero and allows for differences in either direction, so the estimate is uncertain.

This result does not establish that full amplification improves or worsens depression, and it does not establish that the approaches are equivalent. The registry does not report a clinically important difference threshold against which to judge the estimate. The mean scores also do not show how individual participants changed, how many met a particular severity category, or whether outcomes differed across subgroups.

The comparison is not a test of hearing aids against no hearing aid, because the sham group received low amplification. It is also not a test of antidepressants against no antidepressant, because both groups received antidepressant treatment. Since escitalopram or duloxetine could be used, and the record does not report their distribution or separate effects, the posted comparison cannot isolate either drug’s contribution.

The trial’s stated rationale describes possible links between age-related hearing loss, social isolation, and depression. The posted outcome estimates do not establish those causal pathways. Nor do the results settle questions about longer-term effects: the primary endpoint is reported at 12 weeks, and longer-term outcome estimates are not reported in the registry record.

The most defensible reading is that this completed trial posted a small-sample comparison with a broad range of plausible mean differences and limited reported analysis detail. It offers an estimate for the specific contrast and measure recorded, but it does not support a precise or definitive conclusion about the effect of amplification on depression.

17. Why This Trial Matters Statistically

This trial is statistically instructive because it asks a focused question within a complex treatment context. Both randomized groups received antidepressant treatment, while the hearing-aid amplification condition differed. That design targets an incremental contrast between full and low amplification in the context of antidepressant use; it does not estimate the independent effect of each component.

The primary endpoint is continuous, allowing the comparison to use score differences rather than only classifying participants into broad categories. At the same time, a mean difference alone can hide variation in individual responses and does not indicate how many participants moved between severity categories. The registry reports group means and standard errors, but not the participant-level distribution or a change-from-baseline analysis.

The interval illustrates why estimates should be read for precision, not only by whether a p-value is below a threshold. Here, the interval extends across zero and includes differences in both directions. It signals that the trial’s estimate is not sufficiently narrow to distinguish a small or absent contrast from other plausible values under the interval method.

The record also makes clear that a completed trial and a posted result do not necessarily provide all the information needed for a full statistical audit. The original sample-size rationale, analysis plan, analysis population, and missing-data procedures are not reported. Planning calculations based on observed effects can help illustrate future design choices, but they do not replace the original design rationale and are not observed power.

For clinical researchers, the key lesson is to keep the question, estimate, uncertainty, and reporting gaps distinct. The result addresses a specific randomized contrast at a specific time; it should not be expanded into claims about components, mechanisms, or longer-term outcomes that the posted analyses do not establish.

18. 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 trial-specific details unavailable. Eligibility criteria, participant characteristics, baseline HRSD scores, and the distribution of the two antidepressants are not reported. Without those details, it is difficult to assess the representativeness of the outcome groups or the comparability of treatment exposure beyond the randomized hearing-aid assignment.

The primary outcome counts are 12 for sham and 11 for full amplification, while the adverse-event record uses at-risk counts of 14 and 11. Secondary outcome counts are 11 in each group. The reasons for these differences, the amount and pattern of missing outcome data, and the relation between analyzed and randomized participants are not reported in the registry record.

The registry does not report baseline-adjusted results, within-participant changes, a clinically important difference threshold, or participant-level outcome distributions. It also does not report the statistical analysis plan, confidence-interval construction, multiplicity strategy, or analysis population. These omissions limit assessment of prespecification and the sensitivity of the reported result to analytic choices.

The listed primary assessment is at 12 weeks; longer-term primary outcome results are not reported. The safety information is limited to the posted counts and terms, without event-level descriptions, attribution, or a comparative analysis. The record also does not explain the original sample-size rationale. These limitations do not demonstrate that unreported procedures or information were absent from the trial, but they constrain what can be concluded from the registry record.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Treating Hearing Loss to Improve Mood and Cognition in Older Adults — NCT03321006.
• Registry record last updated 2021-10-04; status last verified 2021-09.
• Results first posted 2021-08-19.
• 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.

22. Record Summary

NCT03321006 is a completed, randomized, quadruple-masked, parallel-group Phase 4 trial sponsored by New York State Psychiatric Institute. It compared antidepressant treatment with full-amplification hearing aids against antidepressant treatment with low-amplification sham hearing aids. The registry lists an enrollment of 25, a study start of 2018-05-30, and primary completion on 2021-05-31.

The primary outcome was clinician-rated HRSD score at 12 weeks. The posted mean difference for full amplification versus sham was 1.82, with a confidence interval from -2.879 to 6.519 and an unadjusted p-value of 0.448. The interval includes zero and spans differences in either direction, leaving the estimated contrast imprecise.

Two secondary outcomes and safety counts are also recorded. The original sample-size justification, statistical analysis plan, missing-data procedures, and analysis populations are not reported in the registry record. The posted findings describe the recorded comparison but do not establish a definitive effect of amplification on depression.