This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022 (NCT05573763), a na na study. The primary outcome is Therapeutic Efficacy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05573763 |
| Phase | NA |
| Condition | Obstructive Sleep Apnea |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 40 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fisher and Paykel Healthcare |
| Results posted | Yes |
2. Clinical Question
Population
The condition listed is obstructive sleep apnea. The registry record does not describe eligibility criteria or specify the participant characteristics in more detail; those details are not reported in the registry record. The enrollment was 40.
Intervention
The intervention was the F&P Toffee nasal pillows mask, described as a device. The investigation was intended to evaluate its performance and safety in a home environment.
Comparator
No comparator group is listed. The study is described as single-group, non-randomized, and open-label, so it does not provide a like-for-like control comparison.
Primary question
The primary endpoint was therapeutic efficacy measured using the Apnea-Hypopnea Index (AHI) recorded on PAP therapy machines. The record specifies measurement at baseline and 14±5 days, with the endpoint description referring to AHI after 14 days of use. Numerical AHI results are not reported in the registry record.
In statistical terms, the question is whether the recorded AHI on therapy at the stated follow-up can characterize performance in this group, alongside the safety information recorded during the investigation. Without a control group, any change between baseline and follow-up would be a within-group comparison rather than evidence of a difference relative to another device or treatment. The registry record does not report the participant-level data, a numerical summary of baseline or follow-up AHI, or an analysis of change. It therefore does not allow readers to quantify the observed AHI pattern or its precision.
3. Trial Design
The registry record describes a completed, single-group, non-randomized, open-label device investigation. The intervention was the F&P Toffee nasal pillows mask, and the stated purpose was to evaluate performance and safety in a home environment. The listed condition was obstructive sleep apnea. Enrollment was 40, and the sponsor was Fisher and Paykel Healthcare.
The record lists the start date as 2022-11-14 and primary completion as 2022-12-02. The study status is completed. The phase and allocation are recorded as NA, and masking is listed as none. These entries do not indicate a randomized allocation or a blinded comparison. The arm description likewise characterizes the investigation as single-arm, non-randomized, and open-label.
For a single-group design, the primary endpoint can describe measurements within the enrolled group, but there is no concurrent control group to separate changes associated with the device from other influences over time. This is a general design limitation, not a finding about what caused any particular participant's measurement. The registry record does not report a protocol rationale for selecting the design, a sample-size justification for enrollment, or details of an analysis plan.
Two outcome measures are listed, while no analysis entries are reported. The record does not give numerical efficacy results, confidence intervals, or a statistical test for the primary endpoint. Consequently, the design and intended measurement can be described, but a treatment-effect estimate or its uncertainty cannot be reconstructed from the registry information summarized in the record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Toffee: Nasal Pillows Mask |
|---|---|
| STARTED | 40 |
| COMPLETED | 39 |
| NOT COMPLETED | 1 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | F&P Toffee: Nasal Pillows Mask |
|---|---|---|
| Participants analysed | 39 | |
| Age, Customized: 22+ years of age | Participants | 39 |
| Sex: Female, Male: Female | Participants | 16 |
| Sex: Female, Male: Male | Participants | 23 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 3 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 36 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Therapeutic Efficacy, measured over Baseline and 14±5 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Full Range |
| Unit | events per hour |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is titled therapeutic efficacy and uses the Apnea-Hypopnea Index (AHI), measured in events per hour. The record defines AHI as the sum of apneas and hypopneas divided by hours of sleep. It says AHI is recorded on PAP therapy machines after 14 days of use, with the timeframe listed as baseline and 14±5 days. The endpoint parameter is the mean, and the stated dispersion is the full range.
AHI is used to express the frequency of apneas and hypopneas relative to sleep time. The registry description gives the following usual categories: 5-15/hr as mild, 15-30/hr as moderate, and >= 30/h as severe. These are descriptive thresholds in the endpoint definition; they are not study results. The record does not provide the baseline or follow-up mean, the full range, or a numerical change in AHI.
In general, a mean describes the arithmetic center of observed measurements, while a full range describes the lowest-to-highest span. A range can help convey how widely measurements vary, but it does not by itself show the distribution of observations or the precision of the mean. Without reported endpoint values and participant-level information, neither the mean pattern nor its uncertainty can be assessed for this investigation.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies AHI as the primary endpoint and specifies measurement at baseline and 14±5 days. However, numerical AHI results are not reported in the registry record. There is therefore no posted mean, full range, estimate of change, confidence interval, or test result to interpret. The endpoint definition alone describes what the investigators intended to measure; it does not establish what was observed.
The study has a single group and no listed comparator. In general, a within-group comparison can describe how measurements in a group differ across time, if results are reported. It cannot by itself distinguish a change associated with the device from changes related to other factors that may occur over the same period. This matters particularly when interpreting an uncontrolled investigation: even a numerical difference between baseline and follow-up would not be equivalent to a randomized between-group treatment effect.
The record states that the primary endpoint is a mean with full-range dispersion. A mean offers a compact description of the group, while the range indicates the span of values. Neither quantity is present as a numerical result in the registry record. The record also does not provide a confidence interval or other measure of precision. A confidence interval, in general, expresses uncertainty around an estimate under the assumptions of the analysis; without an estimate and interval, precision cannot be judged.
The safety entries report 0 serious adverse events among 39 at risk, 2 other adverse events among 39 at risk, and 0 deaths. These are the recorded counts. They are not a comparison against another group, and the registry record does not provide event terms for the other adverse events. The counts should be read as limited descriptive reporting rather than as a comparative estimate of risk.
No statistical analyses are listed in the registry record. It does not report a p-value, a model, an adjusted analysis, or an analysis population for the efficacy endpoint. The record also does not report missing-data handling. As a result, readers cannot determine whether all enrolled participants contributed endpoint measurements or how unavailable measurements, if any, were treated.
Overall, the available registry information establishes the design, endpoint definition, and selected safety counts, but not the numerical efficacy findings. It does not support a conclusion about the direction, magnitude, or precision of an AHI change. Nor does the absence of reported efficacy values establish that no change occurred. The appropriate interpretation is limited to the information actually recorded.
9. Statistical Methods Explained
The registry record identifies a mean AHI as the primary endpoint and lists events per hour as its unit. It does not report the statistical analysis used for that endpoint. The explanations below describe general statistical ideas relevant to interpreting this type of measurement; they are not claims about analyses performed in this investigation.
What does a mean describe?
A mean combines the observed measurements into a measure of central location. It can be useful when a group-level summary is the question of interest, but it does not describe every participant's value. The same mean can arise from different patterns of individual observations. The registry lists full range as the dispersion measure, which would communicate the span from the smallest to the largest measurement if the values were reported. A range does not show how observations are distributed within that span and can be strongly affected by extreme values.
For a repeated measurement such as baseline and follow-up AHI, a change score can describe the difference within each participant or a group-level summary of those changes. The registry record does not report a change score or specify whether the analysis compared follow-up values with baseline values. It would be inappropriate to infer a change from the endpoint title or timeframe alone.
What does uncertainty mean?
Statistical precision concerns how much uncertainty surrounds an estimate. A confidence interval is a general way to express that uncertainty, conditional on the data and statistical assumptions used. A narrow interval indicates greater precision than a wide interval, while the interval's location indicates which values remain compatible with the analysis. No confidence interval or numerical AHI estimate is reported in the registry record, so precision cannot be evaluated.
A p-value, in general, describes how compatible the observed data are with a specified null model under the assumptions of a statistical test. It is not a measure of effect size, and it does not by itself indicate whether a result is clinically important. No p-value or test result is reported for the primary endpoint. The registry record also does not specify a null hypothesis or a testing procedure.
Why does the design matter?
In a single-group investigation, measurements can be described within the enrolled group. Without a concurrent comparison group, the design does not directly estimate a difference between the device and an alternative. This limits causal interpretation because other influences on measurements over time are not controlled through a like-for-like comparison. This is a general property of the design, not evidence that any particular influence affected these results.
Randomization, in general, is a way to allocate participants to comparison groups so that known and unknown factors have a chance to be balanced. This investigation is described as non-randomized and single-group, with allocation listed as NA. There is no randomized comparison to interpret. Open-label status and masking listed as none mean that the record does not describe blinding; it does not report whether or how awareness of the intervention was addressed in measurement or analysis.
What can be inferred from event-rate language?
AHI is expressed as events per hour, but the registry defines the endpoint parameter as a mean. A unit expressed per time does not, by itself, specify a statistical model. In general, count or rate data may show over-dispersion when observed variability exceeds what a simple model assumes. Analysts may then consider methods that account for extra variability, but the appropriate method depends on the data and model. The registry record does not report a count model, an over-dispersion assessment, or any statistical method for AHI. It is therefore not possible to say that a particular rate model was used or would be appropriate for these observations.
What do the planning assumptions mean?
The registry record includes planning assumptions for an illustration based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It says the effect to detect is a stated fraction of the observed effect. For time-to-event illustrations, it describes total events using the Schoenfeld approach; other illustrations are expressed as participants per arm. These are planning assumptions, not evidence that the completed investigation used two arms or randomized participants. The actual design is single-group.
The record does not report numerical outputs for those planning illustrations in the information available for interpretation, and it does not report the observed efficacy estimate on which such an illustration would depend. A planning sample size is not observed power. In general, planning calculations depend on assumptions about the effect, variability, significance level, allocation, and analysis method. A sample-size illustration cannot substitute for a reported estimate and uncertainty from the completed study.
Finally, the registry lists no analysis entries. Without a reported analysis, there is no basis for attributing a specific estimator, model, adjustment, missing-data method, or inferential procedure to the trial. General statistical concepts can clarify what would matter, but they cannot fill in methods or results that are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists two outcome measures and no analysis entries. It does not describe a multiplicity plan, such as whether one endpoint was designated for confirmatory testing, how multiple comparisons would be handled, or whether any adjustment was intended. The primary endpoint is identified as therapeutic efficacy, but numerical results and statistical tests are not reported. Without those details, the effect of multiplicity on any inferential conclusion cannot be assessed.
Missing-data methods are also not reported in the registry record. The record does not state whether all enrolled participants had baseline and follow-up AHI measurements, how absent measurements were handled, or whether an analysis population differed from enrollment. It would be unwarranted to assume that all enrolled participants contributed to the endpoint or that missing measurements were handled in a particular way.
In general, missing data can affect both the estimate and its precision, depending on why observations are unavailable and how the analysis addresses them. A complete-case analysis, imputation, or another strategy makes different assumptions; the registry record does not identify one. No analysis population, prespecified statistical plan, interim analysis plan, or sample-size justification is reported in the registry record. These omissions limit assessment of how the efficacy endpoint was analyzed and how robust any unreported finding might be.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| F&P Toffee: Nasal Pillows Mask | 0 | 39 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| F&P Toffee: Nasal Pillows Mask | 0 of 39 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| F&P Toffee: Nasal Pillows Mask | 2 of 39 |
Most frequent non-serious adverse event terms
| Event term | Organ system | F&P Toffee: Nasal Pillows Mask |
|---|---|---|
| Sinus Cold | General disorders | 1 of 39 |
| Muscle soreness | Musculoskeletal and connective tissue disorders | 1 of 39 |
The registry record lists 39 participants at risk for serious adverse events, with 0 affected, and 39 at risk for other adverse events, with 2 affected. It also lists 0 deaths. The record does not provide terms for the other adverse events, and the serious adverse event terms list is empty.
These entries are descriptive counts from the single-group investigation. They do not provide a comparison with another device or a control group. The record does not report event timing, severity details for the other adverse events, or additional information that would explain their clinical context. No rate, percentage, or comparative measure is reported in the registry record, and none can be inferred from these counts alone.
In general, observed event counts describe what was recorded during a study; they do not establish that an intervention caused or prevented an event. The absence of a listed serious event or death is not, on its own, proof that the possibility of such events is excluded. Interpretation is limited by the registry's reported counts and the absence of further event descriptions.
12. What the Result Does, and Does Not, Mean
The record establishes that Fisher and Paykel Healthcare sponsored a completed, single-group evaluation of the F&P Toffee nasal pillows mask in a home environment. The primary endpoint was mean AHI, measured at baseline and 14±5 days, and the stated safety information includes the recorded serious-event, other-event, and death counts. These details describe the intended assessment and the safety entries available in the registry.
The record does not report numerical AHI findings. It therefore does not show the size or direction of any change, the range of observed values, or the precision of an estimate. It also does not report an inferential analysis. The endpoint definition and study completion status cannot stand in for efficacy results, and the record's silence on numerical findings should not be interpreted as evidence of no change.
Because the study has no listed comparator and is described as non-randomized and open-label, it does not provide a controlled estimate of how the device compares with another intervention. In general, measurements from a single group may be informative descriptively, but they cannot isolate the effect of the device from other changes over time. This limits causal conclusions even if within-group results are available elsewhere; those numerical results are not reported in the registry record.
The safety counts are likewise descriptive and lack a comparator. They do not establish comparative safety, and the registry record gives no terms for the other adverse events. The information can support a limited account of what was recorded, but not a broad conclusion about the likelihood of events.
Accordingly, the registry entry documents a device evaluation and its planned measurement framework, while leaving the central efficacy estimate and its uncertainty unreported. It does not establish that the mask works or does not work, nor does it establish a comparative safety profile. The meaning of the posted record is bounded by its design and the results actually recorded.
13. Why This Trial Matters Statistically
This investigation illustrates an important distinction between a clearly defined endpoint and a reported endpoint result. The registry specifies AHI, its unit, its mean parameter, its dispersion measure, and the intended measurement timeframe. Those details help identify what was meant to be assessed. Yet without numerical baseline and follow-up values, the primary efficacy finding cannot be evaluated statistically.
The single-group design also illustrates why design and interpretation must be considered together. A within-group measurement can describe observations over time, but it is not a controlled comparison. Statistical summaries cannot remove the design limitation created by the absence of a comparator. Readers need both the estimate and an understanding of how the study structure constrains its interpretation.
The safety entries show another useful distinction: counts are not the same as a comparative risk estimate. The registry reports serious adverse events, other adverse events, and deaths descriptively, but does not provide a control group or event terms for the other events. These entries are informative as recorded counts, while remaining limited for broader comparisons.
Finally, the record demonstrates why analysis details and missing-data reporting matter. The registry lists two outcome measures but no analysis entries and does not describe an analysis population, statistical plan, or missing-data method. These gaps make it difficult to assess precision, multiplicity, and the robustness of any efficacy estimate. Clear reporting of numerical results, uncertainty, and analytic decisions is essential for readers to judge what a clinical investigation can support.
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 specific record is that numerical results for the primary AHI endpoint are not reported in the registry record. Baseline and follow-up means, full ranges, a change estimate, and measures of uncertainty are unavailable. This prevents assessment of the observed efficacy pattern and its precision.
The design is single-group, non-randomized, and open-label, with no comparator listed. As a result, the registry record does not support a controlled comparison or a causal estimate relative to another intervention. The record also does not describe eligibility criteria or participant characteristics in detail, limiting assessment of how well the enrolled group represents any broader population.
Although the endpoint timeframe is specified as baseline and 14±5 days, the registry record does not explain the analysis of repeated measurements or report participant-level data. Missing-data handling, the analysis population, and the statistical analysis plan are not reported. The record also does not give a sample-size justification or describe any interim analyses.
Safety information is limited to the recorded counts: 0 serious adverse events among 39 at risk, 2 other adverse events among 39 at risk, and 0 deaths. The other adverse event terms are not listed, and the record offers no comparison group. These limitations constrain interpretation of both the efficacy endpoint and the safety reporting.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022 — NCT05573763.
- Registry record last updated 2025-09-22; status last verified 2025-09.
- Results first posted 2025-09-22.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed, single-group, non-randomized, open-label evaluation of the F&P Toffee nasal pillows mask in a home environment. The listed condition is obstructive sleep apnea, enrollment is 40, and Fisher and Paykel Healthcare is the sponsor. The start date is 2022-11-14, primary completion is 2022-12-02, and the status is completed.
The primary endpoint is mean AHI in events per hour, with full-range dispersion, measured at baseline and 14±5 days. Numerical efficacy findings and statistical analyses are not reported in the registry record. Safety entries list 0 serious adverse events among 39 at risk, 2 other adverse events among 39 at risk, and 0 deaths. The registry record does not report a comparator, detailed event terms for the other adverse events, a missing-data method, or an analysis population.