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 Caramel Nasal Mask, US, 2023 (NCT06060717), a na na study. The primary outcome is Therapeutic Efficacy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06060717 |
| Phase | NA |
| Condition | Obstructive Sleep Apnea |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 45 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Fisher and Paykel Healthcare |
| Results posted | Yes |
2. Clinical Question
Population
The record identifies obstructive sleep apnea as the condition under study. It describes a home-environment evaluation and reports enrollment of 45. Further details about eligibility, participant characteristics, and the population included in each analysis are not reported in the registry record.
Intervention
The intervention is the F&P Caramel nasal mask, listed as a device. The stated purpose is to evaluate its performance and safety in a home environment. The record does not provide further details about device use, adherence, or how treatment was managed.
Comparator
There is no comparator group. The design is listed as single-group, non-randomised, and open-label. Consequently, the record does not provide a concurrent control against which changes in AHI or adverse events can be compared.
Primary question
The primary outcome is therapeutic efficacy, measured as AHI in events per hour. The registry describes AHI recorded on PAP therapy machines after 14 days of use, with the timeframe stated as “Baseline and14±5 days.” Higher AHI values represent worse outcomes. The numerical outcome results are not reported in the registry record, so the record does not establish the size or precision of any change.
3. Trial Design
This completed investigation is registered as NCT06060717 and is titled “Evaluation of the F&P Caramel Nasal Mask, US, 2023.” The record lists the sponsor as Fisher and Paykel Healthcare, the condition as obstructive sleep apnea, and the intervention as the F&P Caramel device. It reports enrollment of 45. The listed study dates are 2023-11-27 for the start and 2023-12-11 for primary completion.
The design is single-group, non-randomised, and open-label. Allocation and phase are listed as NA. Because there is no control arm, the study is not a randomized comparison and cannot separate changes associated with mask use from changes that might have occurred for other reasons. Open-label conduct also means that masking is not listed; the record does not describe procedures to reduce knowledge of the device among participants or study personnel.
The stated purpose is to evaluate performance and safety in a home environment. The primary outcome is therapeutic efficacy, measured using AHI recorded on PAP therapy machines after 14 days of use. Its timeframe is written as “Baseline and14±5 days.” Although this wording indicates assessment at baseline and around the follow-up period, further measurement and analysis details are not reported in the registry record.
The registry lists two outcome measures and zero analyses. Numerical primary outcome results, participant flow, and analysis-population definitions are not reported in the registry record. The record therefore identifies the intended design and outcome but does not provide the results needed to estimate the observed change in AHI or assess its uncertainty.
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 | Caramel Nasal Mask |
|---|---|
| STARTED | 45 |
| COMPLETED | 43 |
| NOT COMPLETED | 2 |
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.
Population: Participants with obstructive sleep apnea (OSA) that have been been prescribed positive airway pressure (PAP) therapy
| Characteristic | Unit | F&P Caramel: Nasal Mask |
|---|---|---|
| Participants analysed | 43 | |
| Age, Customized | Participants | 43 |
| Sex: Female, Male: Female | Participants | 18 |
| Sex: Female, Male: Male | Participants | 25 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 39 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Therapeutic Efficacy, measured over Baseline and14±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 therapeutic efficacy measured by the Apnea-Hypopnea Index, or AHI, in events per hour. The registry defines AHI as the sum of apneas and hypopneas divided by hours of sleep. Apneas are complete breathing stops, while hypopneas are shallow breathing episodes. The record says AHI is measured using a PAP device or an overnight sleep study and specifies PAP therapy machine recordings after 14 days of use for this investigation.
AHI is used as a rate because it expresses breathing events relative to sleep time. In general, a rate can help distinguish a larger event count associated with longer observation from a larger frequency of events over a given exposure. The registry states that higher AHI values represent worse outcomes and that there is no maximum theoretical index score.
The record describes the endpoint as a mean with full-range dispersion and gives the timeframe as “Baseline and14±5 days.” It also provides AHI categories: 5-15/hr is mild, 15-30/hr is moderate, and >= 30/h is severe. These definitions explain the measure; they do not show where participants in this investigation fell within those categories. The numerical endpoint results and the details of how baseline and follow-up values were compared are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a single-group evaluation and identifies AHI as the primary outcome, but it does not report the numerical AHI results. No baseline mean, follow-up mean, change estimate, or measure of uncertainty is available in the record. As a result, the direction and magnitude of any observed change, and how precisely it was estimated, cannot be assessed from the registry information.
The lack of a comparator is central to interpretation. Even if a before-and-after change were reported, a single-group design would describe change over time among participants using the device, not the difference between device use and a concurrent alternative. General statistical reasoning: without a control group, other explanations for change cannot be distinguished from an effect associated with the intervention. The record does not describe adjustment methods that might address this limitation.
The primary endpoint is a mean AHI value, and the record says higher values represent worse outcomes. A mean can describe the average level, but by itself it does not show how participant values are distributed. The record specifies full-range dispersion, but does not provide the numerical mean or range for either assessment. The categories in the endpoint description provide context for AHI interpretation, not evidence about the participants’ observed values.
The registry lists enrollment of 45, while the safety group lists 43 at risk for serious and other adverse events. These figures refer to different record entries; the record does not explain the difference or report participant flow. They should not be combined or treated as interchangeable denominators. The safety entries list 0 under serious adverse events, 4 under other adverse events, and 0 deaths. Those counts do not establish comparative safety because there is no control group, and the record does not report event details or a safety analysis.
In general, statistical uncertainty is conveyed by an interval around an estimate: a narrower interval indicates greater precision under the stated analysis, while a wider interval indicates less precision. No confidence interval or other uncertainty estimate for AHI is reported in the registry record. Thus, the record supports description of the planned endpoint and design, but not a quantitative conclusion about the endpoint result or its precision.
9. Statistical Methods Explained
The registry identifies the primary measure as a mean AHI, in events per hour, with full-range dispersion. A mean is the arithmetic average of the values included in an analysis. Dispersion describes how spread out those values are. Reporting both can give a reader more information than a mean alone, but neither can be interpreted numerically without the actual values. The record does not report the primary outcome results or explain how the full range was calculated or presented.
What does a rate mean?
AHI is defined as apneas and hypopneas divided by hours of sleep. This makes it a rate rather than simply a count: the amount of sleep time is part of the measure. In general, rates can be useful when exposure time differs, because they relate events to the amount of time during which events could be observed. The AHI unit in this record is events per hour. The posted results do not include the event counts, sleep-time values, or participant-level AHI measurements needed to inspect how the rate was obtained.
General statistical explanation: count-based outcomes may vary more than a simple statistical model expects, a feature called over-dispersion. When over-dispersion is present, a model that assumes less variability can produce uncertainty estimates that are too small. Whether over-dispersion was assessed or addressed in this investigation is not reported in the registry record. The listed endpoint is a mean rate, but the record does not report a model, distributional assumption, or method for estimating its uncertainty.
How should a before-and-after outcome be read?
The timeframe is stated as “Baseline and14±5 days,” and the description refers to AHI recorded after 14 days of use. In general, paired measurements can account for the fact that baseline and follow-up values come from the same participant, whereas treating them as unrelated observations would ignore that pairing. The registry record does not say whether the analysis used paired differences, a repeated-measures model, or another approach. It also does not report how measurements outside the stated timeframe were handled.
A change estimate would describe the difference between the baseline and follow-up values under the chosen analysis. An uncertainty interval would indicate the precision of that estimate, subject to the model and data assumptions. Neither a change estimate nor an interval is reported in the registry record. The direction and size of any change therefore cannot be inferred from the endpoint definition.
What does a confidence interval communicate?
In general, a confidence interval is an uncertainty range calculated using a specified method. It describes which effect sizes remain compatible with the data and assumptions at the stated confidence level. It is not a guarantee that the true value lies inside the particular interval, and it does not by itself establish practical importance. The registry record does not provide a confidence interval or specify an interval method for the primary endpoint.
A p-value, when reported, evaluates how compatible data are with a specified null hypothesis under a statistical model. It does not measure the size of an effect or its importance. The registry lists zero analyses and does not report a primary-outcome p-value. The planned significance level described for sample-size planning is not an observed test result.
How do the planning assumptions differ from trial results?
The record describes sample-size planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. These are planning assumptions, not a description of the actual single-group design, which has no two-arm comparison. The illustrations are conditional on the effect used in the planning calculation and should not be read as observed power or as evidence that an effect was detected.
The record does not report a sample-size justification for the trial’s single-group design. It also does not state whether interim analyses were performed, whether any alternative statistical methods were planned, or how departures from model assumptions would be handled. Those details are not reported in the registry record. General statistical principle: an analysis method should match the outcome structure and the study design; without the analysis specification and results, the adequacy of that match cannot be evaluated.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and identifies therapeutic efficacy by AHI as the primary endpoint. It lists zero analyses. The other outcome measure is not described in the available record, and the numerical results for the listed outcomes are not reported in the registry record.
Multiplicity arises when multiple outcomes, time points, or statistical comparisons are tested. In general, the more opportunities there are to identify a result as statistically notable, the more important it is to understand whether and how the analysis accounted for those opportunities. The record does not report a multiplicity strategy, a hierarchy of secondary outcomes, or which comparisons were planned. It is therefore not possible to determine whether any adjustment was intended or needed for the analyses actually conducted.
Missing-data methods are also not reported in the registry record. The record does not state how many participants contributed baseline and follow-up AHI values, how unavailable measurements were handled, or whether the analysis used imputation or a complete-case approach. Participant flow and reasons for missing outcome data are not reported. These omissions matter because the values available for analysis may differ from those of participants with missing measurements.
Analysis-population definitions are not reported in the registry record. It is not specified whether the primary analysis included all enrolled participants, only participants who used the device, or another group. The enrollment figure and the safety group’s at-risk figure should not be taken as proof of which participants contributed to the primary outcome analysis.
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 Caramel: Nasal Mask | 0 | 43 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| F&P Caramel: Nasal Mask | 0 of 43 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| F&P Caramel: Nasal Mask | 4 of 43 |
Most frequent non-serious adverse event terms
| Event term | Organ system | F&P Caramel: Nasal Mask |
|---|---|---|
| Common Cold | Respiratory, thoracic and mediastinal disorders | 4 of 43 |
The registry lists the F&P Caramel: Nasal Mask group with 43 at risk for serious adverse events and 0 recorded under serious adverse events. It also lists 43 at risk for other adverse events and 4 recorded under other adverse events. Deaths are listed as 0. No top serious adverse-event terms are listed.
These are descriptive entries for a single-group study. They do not provide a comparison with another device or with no device, and they do not establish whether an event was caused by the mask. The registry record does not report event descriptions, severity details beyond the serious-versus-other grouping, timing, or the method used to collect adverse events. It also does not explain why the safety group’s at-risk figure differs from the enrollment figure.
In general, a zero count in a registry entry means that no event was recorded in that entry; it does not prove that an event is impossible or that all relevant events were observed. The safety figures should therefore be read as the counts recorded for this group, not as a comparative estimate or a complete characterization of risk.
12. What the Result Does, and Does Not, Mean
The record establishes that this completed investigation evaluated the F&P Caramel nasal mask in a home environment, using a single-group, non-randomised, open-label design. It identifies AHI as the primary outcome and gives the intended measurement timeframe. It also records safety counts for the device group. These details describe the study question and the information entered in the registry.
The record does not report the numerical primary outcome results. Without baseline and follow-up AHI values, an estimated change, and an uncertainty measure, it is not possible to determine what the posted results show about the measured outcome or how precisely any estimate was obtained. The outcome definitions and severity categories explain how AHI is described; they are not substitutes for observed data.
The single-group design also limits what can be concluded from any change over time. General statistical interpretation: a before-and-after pattern does not by itself demonstrate that the intervention caused the change, because there is no concurrent comparator to represent what might have happened otherwise. The registry does not report a causal analysis or adjustment strategy.
The safety entries report 0 serious adverse events, 4 other adverse events, and 0 deaths for the listed group. These counts do not show relative safety, do not establish causation, and do not describe the details or timing of events. The difference between enrollment and the at-risk figures is not explained in the registry record.
Accordingly, the record supports a description of the design, endpoint, and recorded safety counts. It does not support a numerical estimate of therapeutic efficacy, a precise assessment of uncertainty, or a comparison of safety against another approach. Those conclusions would require outcome and analysis information that is not reported in the registry record.
13. Why This Trial Matters Statistically
This investigation is statistically notable for the gap between a clearly named primary endpoint and the absence of posted numerical results. AHI is defined as a rate, the outcome direction is stated, and a baseline and follow-up timeframe is given. Yet the registry lists zero analyses and does not report the AHI estimates or their uncertainty. Naming an endpoint makes the question identifiable; reporting its results is necessary to evaluate the answer.
The single-group design also illustrates why design and analysis must be interpreted together. A change from baseline can describe what happened among participants in the study, but without a control group it does not estimate how that change compares with an alternative. This limits causal interpretation regardless of whether the observed change is large or small.
The record’s planning assumptions refer to equal allocation between two arms, whereas the registered study is single-group. Such planning calculations are conditional illustrations rather than a description of the actual design or evidence of observed power. Distinguishing planning assumptions from trial results is important when interpreting any sample-size material.
Finally, the separate enrollment and safety at-risk figures, paired with missing participant-flow details, show why analysis populations and denominators need explicit reporting. Without those details, readers cannot determine which observations contributed to the primary outcome or fully reconcile the safety entries. These issues are general lessons in transparent clinical-trial reporting, not evidence for or against the device’s performance.
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.
Several limitations specific to this record constrain interpretation. First, the registry does not report numerical results for the primary AHI outcome, despite identifying its measure and timeframe. Baseline and follow-up values, a change estimate, and an uncertainty measure are not reported. The statistical results therefore cannot be independently interpreted from the registry information.
Second, the single-group, non-randomised, open-label design has no concurrent comparator. Any reported change would be descriptive of the group over time and would not, on its own, establish that the device caused that change. The record does not describe adjustment methods or procedures intended to address this limitation.
Third, the registry lists enrollment of 45 and a safety group with 43 at risk, but does not explain the difference. Participant flow, exclusions, adherence, missing AHI measurements, and analysis-population definitions are not reported in the registry record. The record also does not specify how missing data were handled.
Fourth, safety information is limited to counts for serious adverse events, other adverse events, and deaths. Event descriptions and timing are not reported, and the record does not provide a comparator or a detailed safety analysis. Finally, the method used to analyse the mean AHI, the handling of repeated measurements, and any multiplicity strategy are not reported. These gaps prevent fuller evaluation of the statistical methods and the results.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Evaluation of the F&P Caramel Nasal Mask, US, 2023 — NCT06060717.
- Registry record last updated 2025-09-23; status last verified 2025-09.
- Results first posted 2025-09-23.
- 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
NCT06060717 is a completed, single-group, non-randomised, open-label evaluation of the F&P Caramel nasal mask in a home environment. The registry identifies obstructive sleep apnea as the condition, lists enrollment of 45, and gives the study dates as 2023-11-27 to 2023-12-11. The primary endpoint is mean AHI in events per hour, recorded on PAP therapy machines after 14 days of use, with the timeframe stated as “Baseline and14±5 days.”
The registry lists two outcome measures and zero analyses. Numerical AHI results and analysis details are not reported in the registry record. The safety group lists 43 at risk, 0 serious adverse events, 4 other adverse events, and 0 deaths. The record does not explain the difference between enrollment and the safety at-risk figure.