A Study to Asses Wellness Using a Brain Sensing Device on Physicians: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for A Study to Asses Wellness Using a Brain Sensing Device on Physicians (NCT04743973), a na na study. The primary outcome is Frequency Adherence to Intervention.

2. Clinical Question

The central question is feasibility of physicians using a wearable device during a period described as involving increased workload, patient volume and stressors. The primary outcome focuses on whether and how often the device was used, rather than on a comparison of clinical outcomes between treatment groups. The registry also identifies stress, sleep and quality of life among the conditions of interest and lists score differences for perceived stress, resilience and LASA as secondary outcomes.

The record does not report an estimate of device-use frequency, the variability in that frequency, or results for the secondary outcomes. It therefore does not establish how frequently participants used the device or whether the listed measures changed. Nor does the registry report an analysis of the relationship between device activity states and the other measures. These missing results limit what can be concluded from the clinical question, even though the study is marked completed.

3. Trial Design

This is a completed feasibility study registered as a single-group study. The intervention is the Muse S™ Headband system, and the registry describes a group of practicing physicians at Mayo Clinic. The registered enrollment is 40. Allocation is listed as NA, masking is listed as none, and the study has no like-for-like control arm. Its phase is listed as NA.

According to the arm description, physicians caring for patients during the COVID 19 pandemic were asked to use the headband at least 4 times per week, for a minimum of 10 minutes on each occasion, over 3 months (12 weeks). That is the requested use pattern, not a reported measure of actual adherence. The primary outcome is frequency of use during active study participation, with times used as its unit and mean and standard deviation as the specified summary measures.

The record identifies secondary outcomes as differences in Perceived Stress Scale (PSS) score, resilience score and LASA score. It lists five outcome measures in total, but the registry record does not report outcome estimates or analysis entries. It also does not report the timing or details of assessments beyond the primary outcome’s 3-month timeframe and the intervention period described in the arm.

The design does not support a direct treatment-versus-control comparison because no comparator group is described. A single-group feasibility design can document whether an intervention was used and can describe measurements collected over time, but without a control group it cannot separate changes over time from effects attributable to the intervention. The registry record does not describe a statistical analysis plan, sample-size justification, interim analyses or procedures for selecting the analysis population.

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 Frequency Adherence to Intervention, measured over 3 months.

The primary endpoint is frequency adherence to the intervention, measured as times used during active study participation over 3 months. The registry specifies that the outcome is to be summarized using a mean and standard deviation. It does not report the resulting mean, standard deviation, or other estimate of use frequency.

This endpoint addresses a practical feasibility question: whether participants used the device, and how often, during the study period. The requested use pattern was at least 4 times per week for a minimum of 10 minutes each time over 3 months (12 weeks). The primary endpoint is frequency, however, and the registry description does not state that the endpoint incorporates the duration of each use or evaluates whether every requested use met the minimum duration.

In general, a mean describes the average value in the observed data, while a standard deviation describes how spread out individual observations are around that average. For an adherence measure, the average alone may not describe how consistently participants used the device; variability is relevant to that interpretation. The registry record does not provide either summary statistic, so the degree of use and its variability cannot be assessed from the posted results.

Frequency of use is not itself a measure of stress, sleep, resilience or quality of life. It can describe engagement with the device, but it does not establish whether those other outcomes changed or whether any change was associated with device use. Results for those questions are not reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry describes a continuous primary outcome, with frequency of use measured in times used and summarized by a mean and standard deviation. It does not provide a numerical outcome estimate or an analysis entry. The following concepts explain how those methods would generally be interpreted; they are not claims about analyses performed in this study.

What do the mean and standard deviation describe?

In general, a mean is a measure of the average in a set of observations. For frequency of use, it would describe average use over the defined study period, subject to the way use was recorded and the observations included. The standard deviation describes the spread of observations around the mean. A larger spread indicates more variation in the recorded values, while a smaller spread indicates that values are more closely clustered. Neither statistic alone describes why participants differed in use.

The registry identifies the mean and standard deviation as the primary outcome’s summary measures, but gives neither result. Without the mean, the level of use cannot be described. Without the standard deviation or another measure of spread, consistency of use cannot be assessed. The requested pattern of use is stated in the arm description, but it should not be mistaken for observed adherence.

What would a confidence interval add?

In general, a confidence interval represents uncertainty around an estimate under the assumptions of the statistical method. It helps readers judge how precisely a quantity has been estimated. A narrow interval generally indicates greater precision than a wide interval, but precision is not the same as freedom from bias. A confidence interval cannot compensate for the absence of a comparison group, errors in measurement or an analysis population that differs from the intended population.

The registry record does not report a confidence interval for the primary outcome or the secondary outcomes. It is therefore not possible to assess their statistical precision from the posted results. No inferential test or p-value is reported either. A p-value, in general, describes how compatible data are with a specified statistical null model; it is not a measure of the size or clinical importance of an effect. No p-value can be interpreted for this study from the registry record.

Why does the single-group structure matter?

A single-group study can describe use and measurements within the group, but it does not include a concurrent control group for comparison. In general, measurements that differ over time may reflect the intervention, changes in the surrounding circumstances, natural variation, measurement effects or other influences. Without a control comparison or a justified alternative design, those explanations cannot be separated by a simple change score.

Here, the registry identifies a primary frequency outcome and secondary score-difference outcomes, but does not report the score estimates or an analysis method. The record also does not describe whether comparisons would be within-person, how repeated observations would be handled, or how association between device states and other measures would be estimated. Those details are not reported in the registry record and should not be inferred from the outcome labels.

How should the planning illustration be understood?

The sample-size assumptions describe a planning illustration based on an observed effect, not the trial’s own design. The stated assumptions are 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 illustration specifies that time-to-event calculations use a total event count, while other calculations use participants per arm.

These assumptions do not make this study a two-arm trial: its registered design is single-group, with no like-for-like control comparison. The registry record does not report an observed effect on which to base a numerical planning interpretation, and does not report the study’s own sample-size justification. Any sample-size illustration is a planning aid, not observed power and not evidence that the study detected an effect. No numerical sample-size result is reported in the registry record.

What does over-dispersion mean in general?

For count outcomes, a basic statistical model may assume a particular level of variation. Over-dispersion means the data vary more than that model expects. If it is ignored, standard errors may be understated and uncertainty may appear smaller than it is. This general issue can matter for counts, but the registry record does not report an over-dispersion assessment or a model for the frequency endpoint. It would be inappropriate to claim that this issue was evaluated or that a particular count model was used.

Overall, the record gives some outcome definitions and summary specifications, but not the calculations needed to assess estimated values, uncertainty or model adequacy. The analysis methods beyond the stated mean and standard deviation are not reported in the registry record.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Muse-S Group")
n   <- c(40)
m   <- c(57.8)
sp  <- c(30.6)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Muse-S Group  40  57.800  30.600  48.014  67.586

11. Multiplicity, Missing Data and Analysis Populations

The registry lists five outcome measures. It names Perceived Stress Scale (PSS) score difference, resilience score difference and LASA score difference as secondary outcomes, alongside the primary frequency-adherence outcome. The registry record does not report outcome results or analysis entries, and does not explain the role of the remaining listed outcome measure.

When a study evaluates several outcomes or conducts several statistical tests, the chance of at least one apparently notable result can increase. In general, multiplicity procedures can address that issue by adjusting how results are interpreted or by specifying a primary testing strategy in advance. The registry record does not report whether a multiplicity adjustment was planned or used, how outcomes were prioritized, or whether there was a hierarchy of tests. No conclusion about multiplicity handling can therefore be drawn.

The record does not report missing-data counts, reasons for missingness, imputation procedures or sensitivity analyses. It also does not identify an intention-to-treat, per-protocol or other analysis population. Enrollment of 40 is reported, but the number of observations included in any outcome analysis is not reported in the registry record. It is consequently not possible to assess whether missing data affected the results or whether the analyzed participants differed from those enrolled.

The registry lists zero analysis entries. This means the record does not offer an analysis description or numerical result for interpreting multiplicity, missingness or analysis populations. The absence of those details should not be read as proof that no analyses were performed outside the registry; their methods and results are simply not reported in the registry record.

12. 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 non-serious adverse event terms

The registry reports zero serious adverse events among 40 at risk and zero deaths among 40 at risk in the Muse-S group. It reports one other adverse event among 40 at risk. No serious adverse-event terms are listed. These are the safety figures recorded in the registry; the record does not provide further detail about the other adverse event.

In general, an at-risk count is the denominator used for the corresponding safety category in the record. The figures should be read as registry-reported counts, not as a detailed account of timing, severity, relatedness or duration. The registry record does not state whether the other event was considered related to the device, how it was managed, or whether additional events were collected outside the reported categories.

Zero reported serious adverse events does not establish that an intervention is free of risk. Safety interpretation depends on the size and characteristics of the population observed, the length and completeness of follow-up, and how events were defined and collected. Those details are not fully reported in the registry record. The listed counts describe what was posted, without supporting broader conclusions about safety.

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

The registry record establishes that a completed, single-group feasibility study evaluated use of the Muse S™ Headband system among practicing physicians at Mayo Clinic. It describes the requested use pattern and defines frequency of use over 3 months as the primary outcome. It also identifies secondary score-difference outcomes related to perceived stress, resilience and LASA. These details clarify what the study set out to examine.

The record does not report the primary outcome result, secondary outcome estimates, uncertainty measures or analysis entries. It therefore does not show how often the device was used, whether scores changed, or whether device-measured active or calm state duration was associated with quality of life, subjective stress, sleep or resilience. The absence of results must not be interpreted as a finding of no change or no association.

The design also limits what could be inferred from changes even if they were reported. There is no control group, so a within-group difference would not by itself establish that the intervention caused the difference. Other changes over time or contextual influences could contribute. The registry does not report an analysis intended to address those issues.

The record’s safety figures report zero serious adverse events and zero deaths, and one other adverse event in the Muse-S group. These counts are limited to what the registry reports and do not establish the absence of risk.

Accordingly, the posted information supports a description of the study question, design, intervention and registered outcome definitions, but not a conclusion about adherence, clinical outcome changes, association or treatment effect. Results and analysis details are not reported in the registry record.

14. Why This Trial Matters Statistically

This study is statistically informative as an example of the distinction between feasibility questions and clinical outcome questions. Its primary endpoint is frequency of device use, which addresses engagement with the intervention. Its secondary outcomes and study summary concern stress, resilience, sleep and quality of life. These are different types of questions and require results suited to each one; a use-frequency measure cannot stand in for an outcome measure.

The single-group structure is also important. Descriptive information can characterize use in the registered group, but a control comparison is absent. In general, this makes causal interpretation of changes more difficult because time trends and other influences cannot be separated from an intervention effect using a direct between-group contrast. The registry does not report an alternative causal analysis.

Precision and transparency matter as well. Means and standard deviations are specified for the primary endpoint, but the estimates are not reported. The registry provides no analysis entries, confidence intervals, p-values, missing-data procedures or analysis-population definitions. Without those details, readers cannot evaluate the magnitude and uncertainty of outcomes or the robustness of any analysis.

The record does state a planning-illustration framework, but that framework is not the study’s design and is not evidence of observed power. Keeping planning assumptions distinct from analyzed results prevents a hypothetical calculation from being mistaken for a trial finding. Here, the registry does not report numerical outcome results or a numerical sample-size illustration.

These points matter because a completed registration record can document the questions a study addressed without providing the results needed to answer them. For this study, the statistical description supports careful interpretation of its scope and design, while the absence of posted analyses prevents conclusions about the outcomes.

15. 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 report primary or secondary outcome results, despite marking the study completed. This is the central limitation for statistical interpretation: the primary frequency measure cannot be quantified, and the listed score differences cannot be evaluated. There are no reported estimates or uncertainty measures with which to judge magnitude or precision.

The design is single-group, with no like-for-like control comparison. This restricts causal interpretation and means that any within-group change, if available elsewhere, could not automatically be attributed to the intervention. The record does not describe an alternative design or analysis that would address this limitation.

The registered enrollment is 40, but the registry record does not report the analysis population, outcome-specific observations, completion of follow-up or missing-data handling. It also does not describe how device use was recorded, how an active or calm state was defined for analysis, or how measurements were linked to the secondary outcomes. These operational and analytic details are not reported in the registry record.

Other limitations of reporting include the absence of a statistical analysis plan, sample-size justification, multiplicity strategy, interim-analysis information and detailed safety-event descriptions. The presence of a planning illustration does not fill these gaps or establish the trial’s design rationale. The safety counts are limited to the categories and denominators posted in the registry.

Finally, the study concerns practicing physicians at Mayo Clinic during the COVID 19 pandemic. The registry does not provide further population characteristics with which to assess how well the study group represents other physicians or settings. Generalizability therefore cannot be judged in detail from the registry record.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: A Study to Asses Wellness Using a Brain Sensing Device on Physicians — NCT04743973.
• Registry record last updated 2024-12-27; status last verified 2024-12.
• Results first posted 2024-12-27.
• 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.

19. Record Summary

The registry describes a completed, single-group feasibility study of the Muse S™ Headband system in practicing physicians at Mayo Clinic. Enrollment is listed as 40. Physicians were asked to use the device at least 4 times per week for a minimum of 10 minutes per use over 3 months (12 weeks). There is no comparator group, and masking is listed as none.

The primary outcome is frequency of use during the 3-month study period, specified in times used and summarized by mean and standard deviation. Secondary outcomes include Perceived Stress Scale (PSS), resilience and LASA score differences. The registry record does not report outcome estimates or analysis entries. It also does not report the statistical analysis plan, missing-data handling or analysis populations.

For safety, the record lists zero serious adverse events, one other adverse event and zero deaths in the Muse-S group. These registry figures do not support broader safety conclusions. The posted information describes the study and its questions, but does not provide results with which to assess adherence, changes in secondary outcomes, associations or treatment effects.