Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting (NCT06229639), a non-randomized na study. The primary outcome is Heart Rate.

2. Clinical Question

The study concerns nocturnal use of a Passy-Muir Valve (PMV) among patients with tracheostomy in an LTACH setting. The registry record describes a crossover arrangement in which patients receive the PMV during night 1 and a tracheostomy plug during night 2. The main question is whether heart rate, the stated primary outcome, differs across those conditions. The record also lists blood gas measures and sleep quality among secondary outcomes.

This is a question about a physiological measure under two specified nighttime conditions, not a broad assessment of every aspect of safety or sleep. The record lists sleep quality, the Richard Campbell Sleep Questionnaire, pH, PCO2, PO2 and bicarbonate as secondary outcomes. It does not report their outcome values in the information available in the registry record. The available information therefore identifies what the investigators intended to assess, but does not establish the size or direction of any observed difference in heart rate, sleep quality, or other measures.

3. Trial Design

The registry record describes a completed study with non-randomized allocation, no masking and a crossover model. Enrollment is listed as 33. The intervention descriptions assign the Passy-Muir Valve to night 1 and the tracheostomy plug to night 2. Thus, the stated order is fixed rather than randomized. The record does not report whether any other aspects of the sequence varied or whether an interval between the two nights was used.

A crossover design means that participants may be observed under more than one condition, so a comparison can potentially use information from the same person under each condition. In general, this can account for stable differences between people. It does not, by itself, ensure a fair comparison: when condition and study period occur in a fixed order, changes over time, adaptation, carryover, or other night-to-night differences may be difficult to distinguish from a condition effect. These are general design considerations, not claims that any such effect occurred in this study.

The registry record explicitly cautions that this is not a randomized comparison and that the arms are not a like-for-like control comparison. The crossover label and the fixed night assignments should therefore be considered together when interpreting the design. No blinding is reported, and masking is listed as none. The record does not describe allocation procedures beyond the non-randomized designation, nor does it report a washout plan, details of participant flow, eligibility criteria, or reasons for any differences between enrollment and the safety counts.

The study is listed as completed. Its start is recorded as 2016-01 and primary completion as 2018-01. The phase is listed as NA. The sponsor is Gaylord Hospital, Inc. These registry entries describe the study record; they do not supply the missing outcome estimates or explain the analytic choices made for the reported measures.

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 Heart Rate, measured over Night 1 at 22:00, 2:00, 6:00 and night 2 at 22:00, 2:00, 6:00.

The primary outcome is heart rate, defined in the registry record as the number of heart contractions per minute and expressed in beats per minute. Heart rate is a continuous measure: it can take a range of values rather than being limited to categories such as present or absent. The record identifies the reported summary as a mean and its dispersion as a 95% confidence interval.

The timeframe lists observations at 22:00, 2:00 and 6:00 on night 1, and at 22:00, 2:00 and 6:00 on night 2. The description says the measurement is an average calculated by dividing the sum of all three time points by 3, and adds that the respective groups were collected at three time points. This wording does not clarify whether the reported mean is calculated separately for each night or condition, or how all listed time points relate to the primary comparison. That detail is not reported in the registry record.

In general, measuring heart rate at specified times can describe a physiological outcome across a night, while a mean condenses observations into a single summary. That summary is useful for describing an average level but does not, on its own, show fluctuations at individual times or identify unusual readings. The registry record gives the outcome definition and timing but does not report the heart-rate means, confidence interval limits, or a comparison estimate. Consequently, the size and precision of the observed primary outcome cannot be interpreted from the available record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The following concepts are general explanations of statistical methods and design issues relevant to the information recorded for this study. The registry record identifies a mean and 95% confidence interval for the primary outcome, but does not report the analysis procedure or numerical results.

What does a mean describe?

In general, a mean is a way to summarize a set of numerical observations by their average level. It can be useful when the question concerns typical values across measurements. A mean does not show the full spread of the observations, reveal whether values changed substantially over time, or indicate whether a small number of unusual observations influenced the summary. For repeated measurements, it is also important to know exactly which observations were combined and whether the mean represents each condition, each time point, or another grouping.

The registry record describes heart rate as an average calculated from three time points and lists three time points on each of two nights. It does not clarify how the summary is formed across the listed schedule or how it maps to the PMV-versus-plug contrast. That is an important reporting detail because different ways of combining repeated measurements answer different questions. The registry record does not report whether results were summarized separately by night, condition, or time point.

How should a confidence interval be read?

In general, a confidence interval expresses the uncertainty associated with an estimate under a statistical model and its assumptions. It is commonly used to show the range of values that remain reasonably compatible with the observed data and analysis. The interval is not a description of the range of individual participant measurements, and it does not by itself establish whether a difference is important. Its width is informative about precision: greater width generally means less precise estimation, while a narrower interval generally means greater precision.

The primary outcome is described with a 95% confidence interval, but no estimate or interval limits are reported in the registry information. Therefore, the precision cannot be assessed. A significance test or its p-value is also not reported in the information available. Without the estimate, interval and analysis details, it would be inappropriate to infer a finding from the outcome definition alone.

Why does the crossover structure matter?

In general, crossover studies collect observations under multiple conditions, often allowing a within-participant comparison. Because observations from the same person are related, an analysis should account for that relationship rather than treat all condition observations as independent. When a valid paired comparison is possible, stable characteristics of each participant may be controlled by comparing that person with themself. This is a general advantage of the design, not evidence about the analysis used in this study.

There are also design considerations. If the order is fixed, the condition may be mixed with period effects, such as changes that occur simply because a later observation takes place on a different night. Carryover is another general concern: an earlier condition could influence a later measurement. A washout interval or an analysis that addresses order and period may be relevant depending on the study, but the registry record does not report a washout plan or the statistical approach. Since PMV is assigned to night 1 and plug to night 2 in the descriptions, the record's non-randomized designation matters to interpretation.

What does non-randomized allocation imply?

In general, random assignment is intended to make treatment allocation independent of participant characteristics and other influences, on average. A non-randomized comparison does not obtain that protection through randomization. In this study, the stated fixed condition order also means that condition and night are not separated by randomized sequencing in the recorded descriptions. This does not prove that bias occurred, but it means that a difference cannot automatically be attributed to the device condition alone. The registry record itself cautions that the arms are not a like-for-like control comparison.

Masking is listed as none. In general, lack of masking can influence behavior, care, assessment, or reporting, depending on the outcome and study procedures. Heart rate is a physiological measure, but the record does not describe measurement procedures or whether awareness of condition could affect collection or management. No particular influence should be presumed from the masking designation alone.

Why can over-dispersion matter?

In general, over-dispersion occurs when observed variability is greater than a statistical model assumes. It is especially relevant to count outcomes and certain generalized models, where underestimating variation can make uncertainty appear too small. The primary outcome in this study is a continuous mean heart rate, not a count endpoint, and the registry record does not report an over-dispersion assessment or a model for the primary analysis. Over-dispersion therefore cannot be said to have affected this result. More broadly, the appropriate uncertainty calculation depends on the outcome distribution, study design, and analysis method.

What can be learned from the listed analysis counts?

The registry record lists 13 outcome measures and 12 analyses. In general, when multiple outcomes or analyses are considered, the chance of at least one apparently notable result can increase if many tests are conducted without a plan for multiplicity. Adjustments or a prespecified hierarchy can help control that issue, but there is no single approach appropriate to every study. The record does not report whether a multiplicity strategy was used, how the analysis counts correspond to the outcomes, or which outcomes were included in any adjustment. These omissions prevent assessment of how multiple comparisons were handled.

The record also does not report a statistical analysis plan, the specific model, the method for estimating uncertainty, or any handling of missing measurements. These details are needed to assess whether an analysis appropriately reflects the crossover structure and the scheduled repeated measurements. The registry description alone does not support reconstructing an analysis or producing recalculated estimates.

10. Multiplicity, Missing Data and Analysis Populations

The registry record lists 13 outcome measures and 12 analyses, including heart rate as the primary outcome and several secondary physiological and sleep measures. It does not explain the relation between the number of measures and analyses, state which comparisons were conducted, or report a multiplicity strategy. In general, assessing several outcomes or contrasts can raise the chance of false-positive findings if each is interpreted without accounting for the broader set of tests. A prespecified primary outcome, adjustment method, or testing hierarchy can address different aspects of this concern, but the record does not report whether any such approach was used. No conclusion about multiplicity control can be drawn from the analysis counts alone.

Missing-data methods are also not reported in the registry record. The description does not state how many heart-rate observations were available at each scheduled time, whether any measurements were missing, what reasons were recorded for missingness, or how missing values were handled. In a crossover study, incomplete observations can affect the ability to make within-participant comparisons. In general, the consequences depend on the amount and pattern of missingness and on the analysis method; no such pattern or method is available.

The record lists enrollment as 33 and lists 30 at risk for each condition in the adverse-event information. It does not explain how these figures relate, or which participants contributed to the primary and secondary outcome analyses. The analysis populations and any exclusions are not reported in the registry record. It is therefore not possible to determine whether the posted analysis, if any, used all enrolled participants or a subset, or how incomplete data affected estimates.

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 record lists the number at risk for serious and other adverse events as 30 for the tracheostomy plug and 30 for the Passy-Muir Valve. It lists zero affected by serious adverse events, zero affected by other adverse events, and zero deaths for each condition. These are the safety figures recorded for the two intervention entries; the registry information does not provide further event details or terms for serious events.

In general, zero events recorded in a study does not prove that an event is impossible or that risk is absent. It describes what was observed and recorded in the specified study population and period. The ability to detect uncommon events depends on the amount and duration of observation, as well as how events are defined and collected. The registry record does not provide enough information to characterize those aspects of safety follow-up.

The enrollment entry is 33, while the safety entries list 30 at risk for each condition. The relationship between these figures is not reported in the registry record. Because the study is described as a crossover, the same participants may have contributed information under both conditions, but the record does not specify the safety population construction. The at-risk counts should not be added together or interpreted as separate groups of participants. These figures also do not provide the heart-rate or sleep outcome results.

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

The registry record establishes that this completed study examined nocturnal PMV use and a tracheostomy plug condition in an LTACH setting, with heart rate designated as the primary outcome. It also identifies a fixed night sequence, a non-randomized allocation, no masking, and a crossover model. These details allow readers to understand the intended comparison and to consider design features that may affect interpretation.

The record does not report the primary outcome estimate, its confidence interval limits, or a statistical comparison. It also does not report the numerical results for the listed secondary outcomes. Therefore, the available information does not show whether heart rate differed between conditions, how large any difference was, or how precisely it was estimated. It also does not establish whether sleep quality or other physiological measures changed. No conclusion about the direction or importance of an outcome can be drawn from the study description alone.

Even if outcome estimates were available, the non-randomized sequence would call for caution. In general, differences between conditions can reflect the condition itself, changes between nights, or other influences. The registry record does not report how the statistical analysis addressed the paired structure or possible period effects. It explicitly cautions that the arms are not a like-for-like control comparison.

The adverse-event entries report zero serious events, zero other events and zero deaths for each listed condition among the stated at-risk counts. Those figures describe the events recorded in the registry; they do not establish that risk is absent or resolve the unreported relationship between enrollment and the safety populations. Overall, this record supports a description of the research question, design and recorded safety counts, but it does not provide enough outcome information to judge the observed heart-rate or sleep findings.

13. Why This Trial Matters Statistically

This study is statistically instructive because its crossover label does not remove the need to examine allocation and order. A within-participant design can support comparisons that account for stable individual differences, in general, but the stated schedule assigns the PMV to night 1 and the plug to night 2. The registry record also identifies allocation as non-randomized and cautions that the arms are not a like-for-like control comparison. These details illustrate why a design name alone is not enough to determine how strong a comparison is.

The record also shows why outcome definitions and reporting details matter. Heart rate is identified as the primary outcome, with a mean and 95% confidence interval, and the schedule lists measurements at three times on each night. However, the description of averaging refers to three time points without clarifying how the two nights enter the summary. A clear statement of the estimand, the observations included, and the contrast being estimated is needed to interpret a numerical result.

Another statistical issue is the distinction between knowing what was measured and knowing what was found. The registry record names several secondary measures and lists counts of outcome measures and analyses, but it does not report their estimates or explain multiplicity handling. Without results and analysis details, readers cannot assess precision, consistency across outcomes, or the effect of missing measurements.

Finally, the safety entries illustrate that event counts require context. The registry lists zero affected for the event categories in both intervention entries, while the relation of those at-risk counts to enrollment is not reported. Statistical interpretation depends on knowing the population, observation period, and completeness of event collection. This record therefore highlights the value of reporting estimates, uncertainty, analysis populations, and methods alongside design and event counts.

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 principal limitation of interpretation is that the registry record does not report the primary heart-rate results. The mean and 95% confidence interval are specified as the intended summary, but no estimate, interval limits, or comparison result is available. Secondary outcome values are likewise not reported. The record can therefore describe the study question but cannot support assessment of the observed effect or its precision.

The primary endpoint description leaves an important detail unresolved. Its timeframe lists three measurement times on each of two nights, while the description says the mean is calculated from all three time points by dividing their sum by 3. The registry record does not clarify whether this summary is calculated per night, per condition, or in another way. The statistical contrast and exact interpretation of the outcome are consequently unclear.

The allocation is non-randomized, masking is absent, and the condition order is specified as PMV on night 1 and plug on night 2. The record does not report whether the analysis addressed possible period or order effects, how the crossover structure was modeled, or whether a washout interval was used. These issues limit causal interpretation in general and are especially relevant when condition and night occur in a fixed sequence.

Further limitations include unreported analysis methods, missing-data handling, analysis populations, participant flow, and multiplicity strategy. Although the record lists 33 enrolled and safety entries with 30 at risk per condition, it does not explain the relationship between those figures. The observation period and details of adverse-event collection are also not described in the available registry information. These gaps prevent fuller evaluation of the outcome and safety findings.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Safety of the Nocturnal Passy Muir Valve and Impact on Sleep Quality at an LTACH Setting — NCT06229639.
• Registry record last updated 2026-03-11; status last verified 2026-03.
• Results first posted 2026-03-11.
• 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, non-randomized crossover study sponsored by Gaylord Hospital, Inc. It lists an enrollment of 33, a start of 2016-01 and primary completion of 2018-01. The study concerns nocturnal Passy-Muir Valve use and its impact on sleep quality in an LTACH setting. The stated schedule assigns the Passy-Muir Valve to night 1 and a tracheostomy plug to night 2; masking is listed as none.

Heart rate, measured in beats per minute, is the primary outcome, with a mean and 95% confidence interval specified. The record lists pH, PCO2, PO2, bicarbonate and sleep-quality measures as secondary outcomes. It lists 13 outcome measures and 12 analyses. Numerical primary and secondary outcome results, analysis details, missing-data methods and multiplicity handling are not reported in the registry record. The safety entries list zero serious events, zero other events and zero deaths for each condition, with 30 at risk in each entry.