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 Amara View Benchmark Study (NCT06535932), a randomized na study. The primary outcome is Patient Preference on Mask Attributes.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT06535932 |
| Phase | NA |
| Condition | Sleep Apnea Syndromes |
| Allocation | Randomized |
| Design model | Crossover |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Philips Clinical & Medical Affairs Global |
| Results posted | Yes |
2. Clinical Question
Population
The study enrolled 35 participants with Sleep Apnea Syndromes. All 35 participants tried both masks in randomized order. The registry record describes mask use with each participant’s prescribed PAP device, but does not report further eligibility details or participant characteristics.
Intervention
The Amara View Minimal Contact Full Face Mask was used for 15 days during its assigned period. The study examined ratings of mask attributes and usage-related outcomes after participants used the mask.
Comparator
The comparator was the F40 Minimal Contact Full Face Mask, identified in the study title as the ResMed AirFit F40. Participants used it for 15 days during its assigned period. The sequence of the two masks was randomized.
Primary question
The primary question was how participant satisfaction ratings for individual mask attributes compared between the Amara View and AirFit F40. Attributes included fit, comfort, seal maintenance, stability, noise, air venting, breathing comfort, sleep quality, visual appeal, bed partner satisfaction, and overall satisfaction. Each attribute was rated separately on a scale from 0 to 10, with higher scores indicating higher satisfaction. The registry record does not report the comparison results.
3. Trial Design
This was a randomized, unmasked crossover benchmark study sponsored by Philips Clinical & Medical Affairs Global. The registry record lists the study as completed, with 35 participants enrolled. The study began on 2024-07-25 and primary completion was 2024-09-06.
At the first visit, participants were fitted with either the Amara View or the AirFit F40. The order of mask use was randomized. After fitting and completion of informed consent, eligibility, and baseline questionnaires, participants took the first mask home and used it with their prescribed PAP device for 15 days. At the second visit, participants returned the first mask and completed a survey about its attributes. They were then fitted with the other mask and used it at home for 15 days. At the third visit, they returned that mask and completed its attribute survey.
A crossover design means that each participant experiences both study conditions, so the comparison can draw on ratings from the same participants under each mask condition. This differs from a design in which separate groups use separate masks. Randomizing the order helps distribute sequence effects across the two mask sequences. However, the registry record does not report whether the analysis accounted for sequence, period, or possible carryover effects.
Masking was listed as none. The record does not state a sample-size justification, details of the randomization procedure, or a prespecified statistical analysis plan. The study’s benchmark label and its randomized crossover structure describe its purpose and conduct, but do not by themselves establish how the outcome data were analyzed.
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 | Amara View First, Then ResMed AirFit F40 | ResMed AirFit F40 First, Then Philips Amara View |
|---|---|---|
| STARTED | 16 | 19 |
| COMPLETED | 16 | 19 |
| NOT COMPLETED | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: All 35 participants tried both masks in randomized order.
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 | All Participants |
|---|---|---|
| Participants analysed | 35 | |
| Age, Continuous | years | 53.5 (SD 9.3) |
| Sex/Gender, Customized: Male | Participants | 20 |
| Sex/Gender, Customized: Female | Participants | 15 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 33 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race/Ethnicity, Customized: Hispanic or Latino/a | Participants | 1 |
| Race/Ethnicity, Customized: Not Hispanic or Latino/a | Participants | 33 |
| Race/Ethnicity, Customized: Not Known or not reported | Participants | 1 |
| Region of Enrollment: United States | participants | 35 |
6. Primary Endpoint
The registry lists the primary outcome as Patient Preference on Mask Attributes, measured over up to 35 days.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | scores on a scale |
| Endpoint classification | Continuous Endpoint |
The primary outcome was patient preference represented by satisfaction ratings for mask attributes. The attributes covered aspects of the mask experience, including fit, comfort, maintaining a seal, stability, noise, air venting, comfort of breathing, sleep quality, visual appeal, bed partner satisfaction, and overall satisfaction. Each attribute was rated separately on a scale from 0 to 10, where 0 indicates the lowest satisfaction and 10 indicates the highest. The scores were not totaled across attributes.
The registry record identifies the mean as the outcome measure and standard deviation as its dispersion measure. A mean describes the average rating for an attribute, while a standard deviation describes how spread out ratings are around that average. Looking at attributes separately preserves the possibility that participants’ impressions differ across mask features rather than treating them as a single combined score.
Preference ratings are relevant to a benchmark comparison because the question concerns participants’ reported experience with each mask. The rating scale gives a structured way to record that experience. It does not, on its own, show the size or certainty of a difference between masks. The registry record does not report attribute-level means, standard deviations, comparisons, confidence intervals, or p-values. It therefore does not establish whether ratings differed or how precisely any difference was estimated.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available registry information describes the study design and the outcomes it intended to assess, but it does not include numerical findings for the primary comparison. The registry record specifies mean satisfaction ratings for individual attributes and gives the scale’s range and direction. It does not report the observed ratings for either mask, the difference between ratings, an uncertainty interval, or a test result. Consequently, the evidence posted in the registry record does not establish the direction, size, or precision of a preference difference.
The distinction between a planned outcome and a reported finding matters. Listing satisfaction attributes explains what participants were asked to rate; it does not indicate how they responded. The statement that all 35 participants tried both masks in randomized order describes the study population and exposure sequence, but does not show whether every rating was available or included in an analysis. The registry record does not report missingness or the analysis population for the primary outcome.
In general, an estimated mean difference would describe the average contrast in ratings between masks for an attribute. A confidence interval would express the uncertainty around that estimate under the statistical method used. A p-value would address compatibility with a specified null hypothesis under its model assumptions; it would not measure the probability that one mask is preferred or establish clinical importance. These general interpretations cannot be applied to this study’s primary outcome because the registry record does not report estimates or inferential results.
The crossover structure is useful to understand when interpreting any future or separately posted results. In a within-participant comparison, ratings from the same person under both masks are related. A suitable analysis would usually need to account for that pairing rather than treating ratings as if they came from unrelated participants. The record does not report the method used, so it is not possible to determine whether the posted registry entry reflects a paired analysis, an adjustment for sequence or period, or another approach. No such method should be assumed.
The registry record lists secondary outcomes involving leak, residual apnea hypopnea index, air pressure, and adherence to PAP therapy. It also lists eight outcome measures overall. But it reports zero analyses, and the primary outcome is not reduced to a single comparison because it includes several attributes. These details underscore why the stated study question should not be mistaken for a numerical answer. The registry entry is informative about what was assessed and how the study was structured; it is not a report of the primary treatment contrast.
Any planning illustration based on an observed effect is distinct from an observed finding and cannot replace an outcome estimate. It also is not observed power. Without reported primary estimates and uncertainty, readers cannot judge whether a difference was small or large, consistent or variable, or estimated with useful precision. The appropriate interpretation is therefore limited to the design and outcome definitions recorded, not a conclusion about which mask received higher preference ratings.
9. Statistical Methods Explained
The registry record identifies the primary measure as a mean on a rating scale and gives standard deviation as the measure of dispersion. These are descriptive statistics: the mean locates the average rating, while the standard deviation conveys how much ratings vary among participants. Neither statistic alone communicates uncertainty in a comparison. A standard deviation describes variability in participant ratings; a standard error or confidence interval, when calculated under an analysis model, addresses precision of an estimated quantity.
What does a mean comparison represent?
For each mask attribute, a comparison of means would summarize how average ratings differ between the Amara View and AirFit F40. Because participants tried both masks, the observations are paired by participant. General statistical practice for a crossover comparison is to preserve that pairing: each participant’s rating under one condition is interpreted in relation to that participant’s rating under the other condition. Treating the two sets of ratings as independent would disregard the within-person structure. The registry record does not report the actual comparison method, so it is not possible to determine how the analysis handled pairing.
A confidence interval, in general, gives a range of values compatible with the observed data and the assumptions of the calculation. A narrower interval indicates greater precision than a wider interval, but its interpretation depends on the model and data. An interval around a mean contrast would help readers assess both the direction and plausible magnitude of the comparison. No confidence interval or other uncertainty estimate for the primary outcome is reported in the registry record.
Why does the crossover structure matter?
In a crossover study, each participant receives or uses each study condition in sequence. This can make within-person comparisons informative because stable differences between participants are less central to the contrast than in a comparison of separate groups. At the same time, a crossover study can be affected by period differences, sequence effects, or carryover from one period into the next. Period effects are changes associated with when the condition is experienced; sequence effects relate to the order of conditions; carryover refers to effects persisting from an earlier period. These are general design considerations, not findings about this trial. The registry record does not state whether the statistical analysis addressed them or whether any washout procedure was used.
Randomization of mask order is recorded, but the specific procedure and allocation concealment are not reported in the registry record. Randomizing order can reduce systematic imbalance in which mask is experienced first. It does not, by itself, guarantee that every possible source of bias is removed, nor does it show how the outcome data were handled.
How should the rating scale be understood?
The outcome description says that each attribute was rated from 0 to 10, with 0 indicating the lowest satisfaction and 10 the highest. The attributes were assessed individually rather than combined into a total. This matters because a participant might rate one aspect of a mask differently from another. A mean score can offer a concise summary for an attribute, but the distribution of ratings and the way a mean comparison was calculated also matter. The registry record does not report those distributions or any attribute-level estimates.
General statistical interpretation also distinguishes statistical evidence from practical importance. A p-value, if reported, would quantify how the data relate to a statistical null model; it would not indicate the size of a preference difference. A confidence interval and a clearly defined threshold for meaningful change can help contextualize an estimate, but the record reports no threshold for meaningful difference. No such threshold should be inferred from the scale alone.
What can planning calculations tell readers?
Sample-size calculations are planning tools whose assumptions affect the number of participants needed to detect a specified effect with a chosen analysis. They do not describe the result observed in a completed trial. The registry record states that its planning illustration is based on an observed effect and uses a two-sided significance level of 0.05, equal allocation, and a normal approximation. It also cautions that the illustration is not the trial’s own design. Those assumptions do not amount to a registry-reported sample-size justification or analysis plan. Planning calculations are not observed power, and they do not show whether the study detected a difference.
Over-dispersion is a general concern when observed variability exceeds what a statistical model assumes. If a model understates variation, its uncertainty estimates may be too optimistic. The registry record does not report a model or variability assessment for these ratings, so over-dispersion cannot be evaluated for this study. More broadly, choosing an analysis requires attention to the paired design, the scale, missing observations, the multiple attributes, and the intended estimand. The statistical analysis plan and the actual methods are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The primary outcome covers multiple mask attributes, and the description says that each attribute was rated and analyzed individually rather than totaled. This creates a multiplicity consideration: when several outcomes are tested or interpreted, the chance of highlighting an unusual result can increase. General approaches include prespecifying a primary comparison, adjusting inference across outcomes, or treating results as exploratory. The registry record does not report a multiplicity strategy, a hierarchy among the attributes, or a designation of one attribute as the sole primary comparison. The record indicates that the primary outcome has several categories or time points and is not reduced to one comparison.
The registry record lists eight outcome measures and zero analyses. It identifies secondary outcomes concerning leak, residual apnea hypopnea index, air pressure, and adherence to PAP therapy, but does not provide their results. It also does not report whether any multiplicity adjustment was applied to secondary outcomes or to the individual preference attributes.
Missing-data handling is not reported in the registry record. The entry states that all 35 participants tried both masks, but does not state whether all completed every rating, whether any observations were missing, or how missing ratings were handled. The analysis population is also not reported. In a crossover study, incomplete observations can affect which within-participant comparisons are available; the registry record does not describe how that issue was addressed. Without these details and outcome estimates, readers cannot assess whether missingness or multiplicity affected the precision or interpretation of any comparison.
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 |
|---|---|---|---|
| Amara View Minimal Contact Full Face Mask | 0 | 35 | 0.0% |
| F40 Minimal Contact Full Face Mask | 0 | 35 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Amara View Minimal Contact Full Face Mask | 0 of 35 |
| F40 Minimal Contact Full Face Mask | 0 of 35 |
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 |
|---|---|
| Amara View Minimal Contact Full Face Mask | 21 of 35 |
| F40 Minimal Contact Full Face Mask | 25 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Amara View Minimal Contact Full Face Mask | F40 Minimal Contact Full Face Mask |
|---|---|---|---|
| Skin Irritation | Skin and subcutaneous tissue disorders | 17 of 35 | 18 of 35 |
| Breathing Discomfort | Respiratory, thoracic and mediastinal disorders | 4 of 35 | 5 of 35 |
| Aeorophagia | Gastrointestinal disorders | 0 of 35 | 1 of 35 |
| Knee Surgery | Musculoskeletal and connective tissue disorders | 0 of 35 | 1 of 35 |
The registry record lists serious adverse events separately from other adverse events for each mask group. For the Amara View, 35 participants were listed as at risk for serious adverse events and 0 were listed as affected; for the F40, 35 were listed as at risk and 0 were listed as affected. The record lists 0 deaths for each mask group.
For other adverse events, the registry lists 21 affected among 35 at risk for the Amara View and 25 affected among 35 at risk for the F40. These are counts recorded by mask group, not estimates of a causal difference between masks. The registry record does not report event terms, severity details for these other events, timing, or attribution. It does not provide a statistical comparison of the groups.
In a crossover study, participants used both masks, so group counts should not automatically be read as independent parallel-group totals. The entry does not explain how adverse events were assigned to a mask or period, or whether participants could contribute events during both periods. Zero serious events recorded does not establish that no possible serious event could occur; it describes what the registry lists for this study. The figures are limited safety information and do not determine a comparative safety profile.
12. What the Result Does, and Does Not, Mean
The registry record supports a description of a randomized crossover study in which 35 participants used both the Amara View and AirFit F40 masks in randomized order. Each mask was used for 15 days with the participant’s prescribed PAP device, and participants completed surveys on mask attributes. The primary outcome was a set of separate satisfaction ratings, not a combined score. The registry also identifies outcomes related to leak, residual apnea hypopnea index, air pressure, and PAP adherence.
What the registry record does not provide is the primary outcome result. There are no reported attribute-level means, standard deviations, mask contrasts, confidence intervals, or p-values, and the record lists zero analyses. It is therefore not possible to say from this entry which mask had higher ratings, whether any difference was statistically distinguishable, or how precise an estimate might be. The lack of a reported analysis is not evidence that the masks had the same ratings.
Even if a numerical difference were reported elsewhere, its interpretation would depend on the analysis, the paired nature of the observations, variation in ratings, missing data, and the approach to multiple attributes. Statistical significance alone would not establish that a difference is important to participants. Likewise, a difference in self-reported satisfaction would not, by itself, establish a difference in the secondary usage or clinical measures listed in the registry.
The safety counts describe adverse events as listed in the registry record, but provide limited detail and no comparative analysis. They should not be treated as proof that either mask is safer. Overall, this record documents the study question, design, duration of use, outcome definitions, and safety counts, but does not support a conclusion about comparative preference or effectiveness.
13. Why This Trial Matters Statistically
This study is statistically interesting because its crossover design compares two masks within the same participants. A within-person design can make the comparison more directly focused on how an individual rates each mask, rather than relying only on differences between separate participant groups. Randomizing the order of mask use addresses the possibility that the first or second period might systematically favor one mask. These design features make it especially important to understand whether the analysis preserved the paired structure and considered period or sequence effects.
The outcome is also multidimensional. Participants rated individual attributes such as fit, comfort, seal, noise, sleep quality, and overall satisfaction. Keeping attributes separate avoids collapsing distinct experiences into a total score, but creates a need to interpret multiple comparisons thoughtfully. The record does not report a hierarchy or multiplicity approach. This highlights a general statistical issue: clear outcome definitions and a prespecified analysis strategy help readers distinguish confirmatory findings from patterns that may be exploratory.
The registry’s reporting gap is itself relevant to statistical interpretation. A trial can have a clearly described question and design while leaving readers without estimates and uncertainty. Without those results, readers cannot assess magnitude, precision, or consistency of preference ratings. Nor can the listed planning assumptions or safety counts stand in for the primary analysis. The study therefore illustrates why registration details and outcome results serve different purposes: the former describe what was planned or conducted, while the latter are needed to evaluate the observed comparison.
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 interpretation is that the registry record does not report the primary outcome estimates or analysis results. Although it defines the preference attributes and rating scale, it does not give the mean ratings, standard deviations, contrasts, confidence intervals, or p-values. The entry lists zero analyses, so no conclusion about the direction, magnitude, or precision of a preference difference can be drawn from these registry data.
The outcome includes multiple attributes that were analyzed separately, but the record does not describe a multiplicity strategy or identify a hierarchy among the attributes. Missing-data procedures and the analysis population are also not reported. The statement that all 35 participants tried both masks does not establish that all outcome ratings were complete or included in an analysis.
Although mask order was randomized, the registry record does not provide details of the randomization method or state whether the analysis accounted for period, sequence, or carryover effects. Masking was listed as none. The record does not report whether participants or outcome assessors were blinded to the mask, nor does it describe the measurement properties of the satisfaction scale or a threshold for a meaningful difference.
The adverse-event entry gives counts but does not list event terms or explain attribution by mask or period. It also does not provide a statistical safety comparison. Finally, the record does not report a sample-size justification or the trial’s statistical analysis plan. These limitations are specific to the information recorded and do not establish that the unreported procedures or analyses were absent from study conduct.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Amara View Benchmark Study — NCT06535932.
- Registry record last updated 2025-08-03; status last verified 2025-07.
- Results first posted 2025-08-03.
- 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
NCT06535932, the Amara View Benchmark Study, was a completed randomized, unmasked crossover study sponsored by Philips Clinical & Medical Affairs Global. The registry lists 35 enrolled participants with Sleep Apnea Syndromes. Participants used the Amara View and F40 masks for 15 days each, in randomized order.
The primary outcome was satisfaction ratings for individual mask attributes on a scale from 0 to 10. Secondary outcomes included leak, residual apnea hypopnea index, air pressure, and adherence to PAP therapy. The registry record lists eight outcome measures and zero analyses.
Serious adverse events affected 0 participants in each mask group, and deaths were listed as 0 in each group. Other adverse events affected 21 participants in the Amara View group and 25 in the F40 group. The primary comparison results, analysis methods, missing-data handling, and multiplicity approach are not reported in the registry record.