Juno Perth Clinical Trial: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Juno Perth Clinical Trial (NCT02317042), a randomized na study. The primary outcome is Apnoea-Hypopnoea Index (AHI).

2. Clinical Question

The main statistical question is whether the posted AHI summaries distinguish the two iVAPS modes from the Standard ST Mode reference, and how precisely those differences are estimated. The study was randomized and crossover, so the same participants were assessed under different modes on separate nights. That design can support within-participant comparisons, but the registry results presented as means, standard deviations, and unadjusted mean differences do not give the paired participant-level contrasts. Consequently, the displayed differences should be read as simple contrasts of the posted summaries rather than as a full analysis of the crossover data.

The trial was terminated, and the registry gives enrollment as 25. The reason for termination is not reported in the registry record. The results therefore describe a limited set of one-night observations in a small study; they do not establish how these modes compare over longer periods or across outcomes that were not reported.

3. Trial Design

The registry describes a randomized, triple-masked crossover study with enrollment of 25. The listed phase is NA. The study was sponsored by ResMed, began on 2015-05-29, had primary completion in 2015-11, and is recorded as terminated. The reason for termination is not reported in the registry record.

The study description sets out two phases, in a sleep unit and in the home environment. The posted arm descriptions, however, focus on polysomnography (PSG) studies on successive nights. Participants first underwent a titration night on Standard ST Mode while receiving their standard non-invasive ventilation therapy through the Juno clinical trial device. Their current ventilation settings were reviewed and re-titrated. On Night 2 or Night 3, participants received either AutoEPAP iVAPS or Fixed EPAP iVAPS according to computer-generated randomization. The order of those two modes was randomized 1:1. The description does not give further detail about the home phase or how its results were included.

Each arm summary reports 25 participants. In a crossover study, those summaries should not be interpreted as evidence that 75 different people were studied across the three modes: the arm descriptions indicate that participants received multiple modes. The registry does not report the number of participants with data available for each specific comparison beyond the arm summaries.

Although the registry labels masking as triple, which roles were masked and how masking was maintained are not reported in the registry record. The planned sequence, handling of period effects, carryover, and participant withdrawals are also not described in the posted results. These details matter because observations from different nights in the same person are related, and a suitable crossover analysis generally needs to account for that structure. No statistical analysis plan or detailed model is reported in the registry 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.

Before assignment: An overnight PSG retitration was performed by experienced sleep technologists to ensure current EPAP \& other device settings were optimal. Titration took place with the device in ST mode with the patient's usual therapy setup. If the device settings were not optimal or if other problems such as patient-device dysynchrony, then the ventilator settings were adjusted by the sleep technologist based on current guidelines. Retitration studies were reviewed by at least 2 experienced sleep physicians.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Participants included in the study were those with a documented diagnosis of respiratory insufficiency and /or respiratory failure due to Chronic Obstructive Pulmonary Disease (COPD), Obesity Hypoventilation Syndrome (OHS) and Neuromuscular Disease (NMD).

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 Apnoea-Hypopnoea Index (AHI), measured over 1 night.

The primary endpoint is the Apnoea-Hypopnoea Index (AHI), reported as a mean with standard deviation in events/hour over 1 night. It counts apneas and hypopneas per hour of sleep. The measure is used to describe the frequency of these breathing events during sleep, making it relevant to a study evaluating sleep-breathing treatment modes.

The endpoint description says AHI was measured using AutoEPAP iVAPS versus Fixed EPAP iVAPS. In the posted outcome summaries, the mean AHI was 3.87 with Standard ST Mode, 3.57 with AutoEPAP iVAPS, and 4.09 with FixedEPAP iVAPS, with 25 participants recorded for each mode. These are descriptive group summaries, not a direct estimate of the AutoEPAP-versus-FixedEPAP difference. The posted estimates instead compare each iVAPS mode with Standard ST Mode.

AHI is a continuous measure, so results can be expressed as differences in means and accompanied by confidence intervals. A mean difference describes the direction and size of the contrast in the units of the endpoint; it does not by itself explain whether a difference is important to patients or clinically meaningful. A threshold for clinical importance is not reported in the registry record. Nor does the registry explain how missing sleep recordings, unusual values, or the repeated-night structure were handled in the primary analysis.

7. Results Posted in the Registry

• AutoEPAP iVAPS: mean 3.57 versus 3.87 on control; difference -0.30 (95% CI -3.14 to 2.54), standardized effect d = -0.06; z-test p = 0.836.
• FixedEPAP iVAPS: mean 4.09 versus 3.87 on control; difference 0.22 (95% CI -3.04 to 3.48), standardized effect d = 0.04; z-test p = 0.895.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Oxygen Desaturation Index

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • AutoEPAP iVAPS: mean 4.45 versus 5.06 on control; difference -0.61 (95% CI -3.53 to 2.31), standardized effect d = -0.12; z-test p = 0.682.
  • FixedEPAP iVAPS: mean 5.70 versus 5.06 on control; difference 0.64 (95% CI -3.63 to 4.91), standardized effect d = 0.08; z-test p = 0.769.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between AutoEPAP iVAPS and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FixedEPAP iVAPS and the control. The interval gives the range of effects that remain compatible with the data.

Mean Oxygen Saturation

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • AutoEPAP iVAPS: mean 94.01 versus 93.99 on control; difference 0.02 (95% CI -1.05 to 1.09), standardized effect d = 0.01; z-test p = 0.971.
  • FixedEPAP iVAPS: mean 94.33 versus 93.99 on control; difference 0.34 (95% CI -0.79 to 1.47), standardized effect d = 0.17; z-test p = 0.557.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between AutoEPAP iVAPS and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FixedEPAP iVAPS and the control. The interval gives the range of effects that remain compatible with the data.

Time Spent Below 90% Oxygen Saturation

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • AutoEPAP iVAPS: mean 37.03 versus 37.26 on control; difference -0.23 (95% CI -46.30 to 45.84), standardized effect d = -0.00; z-test p = 0.992.
  • FixedEPAP iVAPS: mean 34.31 versus 37.26 on control; difference -2.95 (95% CI -52.78 to 46.88), standardized effect d = -0.03; z-test p = 0.908.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between AutoEPAP iVAPS and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FixedEPAP iVAPS and the control. The interval gives the range of effects that remain compatible with the data.

The registry identifies a broad set of secondary outcomes, including measures of oxygenation, carbon dioxide, and sleep. Detailed numeric summaries and simple comparisons are posted for Oxygen Desaturation Index, Mean Oxygen Saturation, and Time Spent Below 90% Oxygen Saturation. The registry indicates additional secondary outcome measures, but their detailed results are not all present in the record summarized by these statistics. Results for outcomes without posted numeric summaries are not reported in the registry record.

Across the detailed secondary results, the comparisons with Standard ST Mode have estimates close to zero relative to the uncertainty in those estimates. Their confidence intervals include zero, and the unadjusted p-values do not offer strong evidence of a difference in these simple contrasts. This broad pattern is consistent with the primary AHI comparisons in the limited sense that neither set of posted comparisons gives a precise, clear estimate of a difference from Standard ST Mode. It does not establish that the outcomes are equivalent, nor does it supply the direct AutoEPAP-versus-FixedEPAP contrast named for the primary endpoint.

Secondary outcomes usually carry less weight for a primary conclusion because they are additional questions, often involving multiple comparisons. When many outcomes and contrasts are examined, the chance of finding an apparently unusual result by chance can increase. The registry does not report a multiplicity adjustment or a prespecified hierarchy for the secondary outcomes. Accordingly, the secondary findings are best read as exploratory descriptions rather than independent confirmatory evidence.

The secondary measures also differ in meaning and units, so their numerical effects cannot be combined into a single conclusion without a prespecified approach. The registry record does not report such an approach. As with the primary endpoint, the repeated-night crossover design and missing detail about paired analyses limit interpretation of the simple contrasts. No conclusion about longer-term effects follows from the one-night outcome summaries.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Oxygen Desaturation Index
• Mean Oxygen Saturation
• Time Spent Below 90% Oxygen Saturation
• Mean Transcutaneous Carbon Dioxide (PtcCo2)
• Sleep Duration
• Sleep Efficacy
• Sleep Latency-Wake After Sleep Onset Time
• Total Sleep Time Spent in Each Sleep Stage

9. Statistical Interpretation

10. Statistical Methods Explained

The primary and secondary measures are continuous outcomes reported as means and standard deviations. A mean is the arithmetic average of the recorded values; a standard deviation describes the spread of individual observations around that average. The standard deviation is not the uncertainty in the mean. The latter depends on the spread and the amount of information available, and is reflected in the confidence interval for a comparison.

What does a mean difference represent?

A mean difference is the mean in one group or condition minus the mean in its stated reference. A negative estimate indicates a lower mean in the named condition than in the reference; a positive estimate indicates a higher mean. The units remain those of the outcome, so the AHI difference is expressed in events/hour. For the posted primary contrasts, AutoEPAP iVAPS is compared with Standard ST Mode and FixedEPAP iVAPS is compared with Standard ST Mode. The endpoint description names a different pairwise comparison, AutoEPAP iVAPS versus Fixed EPAP iVAPS, but a direct estimate for that contrast is not reported in the registry record.

These displayed estimates are unadjusted comparisons calculated from posted summary statistics. They do not incorporate an explicitly reported model for repeated observations, participant-level matching, sequence, or night. A conventional comparison of independent group means treats the observations as independent. In a crossover, measurements from the same participant are generally related, so a paired analysis can use that relationship. The participant-level paired results and a crossover-adjusted analysis are not reported in the registry record. The displayed unadjusted results are therefore useful as simple descriptive contrasts but should not be mistaken for a documented analysis that accounts for the full design.

How should a confidence interval be understood?

A confidence interval expresses statistical uncertainty around an estimate under the method used to calculate it. A relatively narrow interval indicates greater precision for that estimate; a wide interval indicates less precision. An interval that includes zero is compatible with no mean difference, as well as with differences in either direction within the interval. It does not prove that the true difference is zero. The primary intervals extend across zero and include both lower and higher values relative to Standard ST Mode, so the results do not pin down the direction or size of a difference precisely.

What do the p-values tell the reader?

A p-value describes how compatible the observed data are with a specified null hypothesis under the assumptions of the analysis. The posted primary p-values are unadjusted. They are not the probability that the null hypothesis is true, nor a measure of clinical importance. A larger p-value does not establish equivalence, and a smaller p-value would not on its own establish that an effect is important. Interpretation should consider the estimate, its confidence interval, the design, and the analysis assumptions rather than treating a p-value as a stand-alone verdict.

Why does over-dispersion matter?

General statistical explanation: over-dispersion means that observations vary more than a model assumes. When a model understates variability, its standard errors may be too small and its confidence intervals too narrow. AHI is reported as a continuous measure with standard deviations, and the registry does not describe a count model or an over-dispersion assessment. The relevant issue for these posted summaries is that variability is substantial relative to the estimated mean differences, and the confidence intervals are broad. No additional dispersion adjustment is reported in the registry record.

How does the crossover structure affect interpretation?

General statistical explanation: crossover studies collect observations under more than one condition in the same participant. A direct within-person contrast can account for stable differences between participants and often has a different uncertainty from a comparison that treats conditions as independent. It may also be important to account for the order or period in which conditions were experienced, and for possible carryover from one condition to another. The randomized sequence and the first-night Standard ST Mode assessment are described, but the registry record does not report the paired outcome data, a model for period or sequence, or an assessment of carryover. As a result, a reader cannot verify how these design features were handled in the posted estimates.

The registry lists no reported analyses for the primary outcome and no secondary reported analyses. The posted numeric summaries still permit descriptive interpretation, but they do not document the analysis methods in enough detail to establish that all relevant design features were accounted for. The original statistical analysis plan, treatment of missing observations, and any interim analyses are not reported in the registry record. No assumptions should be made about them.

11. Confidence Intervals and Precision

The primary comparison estimates are small relative to the uncertainty expressed by their confidence intervals. For AutoEPAP iVAPS versus Standard ST Mode, the mean difference is -0.3 events/hour, and the interval runs from -3.139 to 2.539. For FixedEPAP iVAPS versus Standard ST Mode, the mean difference is 0.22 events/hour, and the interval runs from -3.036 to 3.476. Each interval includes zero and extends to values on both sides of zero.

These intervals indicate that the posted data do not estimate the direction and magnitude of the mean differences precisely. They allow a range of possible effects, including lower and higher AHI than Standard ST Mode. The intervals are not evidence that all values within them are equally plausible, and their endpoints are not guaranteed boundaries for the true effects. They describe uncertainty under the calculation used for the displayed, unadjusted comparisons.

The reported standard deviations also show variability among observations: 6.19 for Standard ST Mode, 3.76 for AutoEPAP iVAPS, and 5.54 for FixedEPAP iVAPS. In the context of a crossover, the marginal means and standard deviations do not reveal how each participant's measurements changed from one mode to another. Without the within-participant correlations or paired differences, the precision of a design-aware crossover contrast cannot be assessed from the posted summaries alone.

No confidence interval for a direct AutoEPAP-versus-FixedEPAP comparison is reported in the registry record, despite that pair being named in the endpoint description. The registry also does not report a clinically meaningful threshold for AHI differences. Statistical precision and clinical importance are separate questions; the posted intervals address uncertainty in the mean contrasts, not whether any particular difference would matter clinically.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The planning figures are illustrations based on the observed effect, not the trial's original design calculation. For these continuous outcomes, the figures are participants per arm, rather than a total number of events. The planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is set at the stated fraction of the observed effect. The original sample-size assumptions for this trial are not reported in the registry record.

The 80% power column describes the planned number of participants per arm under those assumptions for a design with an 80% chance of detecting the specified effect if that effect were the true one. The 90% power column describes the corresponding target for a 90% chance. These are design-planning concepts, not guarantees about a future study. They depend on the assumed effect, variability, allocation, significance level, and analysis model. The posted illustration uses the observed effect as its starting point, so it should not be treated as an independently established effect size.

Rows for planning for 75% or 50% of the observed effect represent smaller target effects than planning for 100% of the observed effect. Smaller effects are harder to distinguish from random variation, so they require more participants under the stated assumptions. The displayed estimates can become extremely large when the observed effect is very small relative to the variability; such values indicate the sensitivity of the calculation to the effect-size input, not a recommended target for this trial.

This is not observed power. The figures do not measure the probability that the completed study detected an effect, and they cannot repair the imprecision of the posted results. They are hypothetical planning illustrations based on simple assumptions; the original design rationale, crossover-specific calculation, and recruitment target justification are not reported in the registry record.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.300; pooled standard deviation σ = 5.121.
2. n = 2 × (1.96 + 0.842)² × 5.121² / -0.300² = 4,574.5, rounded up to 4,575 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.3                      # observed difference in means
sigma <- 5.12121567598944                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(2317042)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 4,575 (80% power), 6,124 (90% power)
 75% of observed effect: n per arm = 8,133 (80% power), 10,887 (90% power)
 50% of observed effect: n per arm = 18,298 (80% power), 24,496 (90% power)
power.t.test: 4575.4 
Simulated power at n = 4,575 per arm: 0.801 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple outcome measures and comparisons, but does not report how multiplicity was handled. Testing several outcomes or contrasts can increase the chance of at least one apparently notable result arising from random variation. Adjustments, hierarchical testing, or a clearly prespecified primary comparison can address that concern, but the choice of strategy and any application of it are not reported in the registry record. The posted p-values are unadjusted and should be interpreted accordingly, especially for secondary outcomes.

The registry names AHI as the primary outcome and describes AutoEPAP iVAPS versus Fixed EPAP iVAPS. The posted estimates instead compare each of those modes with Standard ST Mode. The record does not explain whether the primary contrast changed, whether additional comparisons were intended, or which contrast governed the original analysis. The statistical analysis plan is not reported in the registry record, so the prespecified status of the displayed contrasts cannot be confirmed.

Missing-data methods and the analysis population are also not reported in the registry record. Enrollment is 25, and the arm summaries each list 25 participants, but those figures do not describe whether every participant contributed usable data to every night or outcome. The number randomized, the number completing each sequence, reasons for missing sleep recordings, and any imputation or exclusion rules are not given. It is therefore not possible to determine from the posted summaries whether the results represent all randomized participants or a subset with available observations.

The record does not describe interim analyses, stopping rules, or the reason the study was terminated. These matters can affect how results are interpreted, but no explanation should be inferred from the termination status alone. No sensitivity analysis for missing data, period effects, or carryover is reported. The resulting uncertainty concerns not only the size of the estimates but also the analysis choices and population to which they apply.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: multiple falls (4.0%).

The posted serious adverse event figures list 25 participants at risk in each mode. The number affected was zero for Standard ST Mode, one for AutoEPAP iVAPS, and zero for FixedEPAP iVAPS. The registry lists zero deaths in each group. These are participant counts as recorded in the safety results; they do not describe event severity beyond the serious-event classification or provide detail about timing and relatedness for each event.

The record also lists Multiple Falls with a value of 4.0% among the serious adverse event terms. The registry does not explain the relationship between that term and the group-level participant counts, so the figures should not be reconciled by inference. Other non-serious adverse event counts were four for Standard ST Mode, two for AutoEPAP iVAPS, and two for FixedEPAP iVAPS, with 25 at risk in each mode.

These counts come from a study with enrollment of 25 and short, one-night assessments described for the modes. Small counts and limited exposure make the safety summaries descriptive; they do not establish comparative safety or rule out uncommon events. The registry does not report event attribution methods or additional safety-analysis details.

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

The posted results show mean AHI values of 3.87 events/hour for Standard ST Mode, 3.57 for AutoEPAP iVAPS, and 4.09 for FixedEPAP iVAPS. The unadjusted comparisons of each iVAPS mode with Standard ST Mode have confidence intervals that include zero and cover values in both directions. The posted data therefore do not precisely establish the direction or size of either mean difference.

That interpretation is not the same as concluding that the modes are equivalent. A non-significant unadjusted comparison does not show that differences are absent; the uncertainty may include effects that are lower or higher than the reference. Equivalence or non-inferiority would require a prespecified margin and an analysis designed to answer that question. Neither is reported in the registry record.

The registry describes a randomized, triple-masked crossover study, but the posted contrasts are simple unadjusted comparisons of summaries. No paired participant-level contrasts or crossover-adjusted model are reported. The results should therefore not be treated as a definitive analysis of the within-participant design. In addition, the primary endpoint description names AutoEPAP iVAPS versus Fixed EPAP iVAPS, while the posted estimates compare each with Standard ST Mode. A direct estimate for the described pairwise primary question is not reported in the registry record.

The endpoint covers one night, and the record does not give a clinically meaningful AHI threshold or results for longer-term use. It also does not report the reason for termination, detailed missing-data handling, or the original analysis plan. These limitations mean that the posted results answer a narrow descriptive question about the available one-night summaries. They do not establish broader clinical benefit, lack of benefit, or comparative performance over time. No medical decision should be based on these statistical summaries alone.

17. Why This Trial Matters Statistically

This study illustrates why design details and statistical reporting matter as much as the direction of a point estimate. A crossover design measures participants under more than one condition, making within-person comparisons potentially informative. Yet the posted summaries do not include the paired differences or explain how repeated observations were modeled. Without that information, readers cannot tell whether the estimates and intervals reflect the study's crossover structure.

The registry also makes the target comparison difficult to identify. Its primary endpoint description frames AHI as AutoEPAP iVAPS versus Fixed EPAP iVAPS, while the posted comparisons use Standard ST Mode as the reference for each. Reporting the intended contrast directly, with an uncertainty interval and an analysis suited to the design, would make the main statistical question clearer.

The study further demonstrates the distinction between a lack of precise evidence for a difference and evidence that treatments are equivalent. The primary intervals include zero but are broad enough to include differences in either direction. The small enrollment and one-night outcome window limit precision and scope; they do not support a conclusion that the modes have the same results.

Finally, planning illustrations based on observed effects should not be confused with the original sample-size rationale or with evidence about the trial's achieved power. The trial-specific assumptions are not reported in the registry record. Transparent reporting of the planned estimand, participant flow, missing-data approach, multiplicity strategy, and crossover analysis would improve interpretability and allow readers to assess how the posted summaries relate to the design.

18. 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 are specific to this record. First, the endpoint description and posted contrasts do not align: the primary outcome is described as AutoEPAP iVAPS versus Fixed EPAP iVAPS, but no estimate for that direct contrast is posted. The reported estimates instead use Standard ST Mode as the reference. The registry does not explain this discrepancy.

Second, the crossover design is described, but the posted results do not include paired differences, participant-level covariance, or a model accounting for repeated measurements. There is no reported analysis of sequence, night or period effects, or carryover. Consequently, the simple unadjusted mean differences may not represent the intended crossover analysis.

Third, the study was terminated, and the reason is not reported in the registry record. Participant flow, completion by sequence, missing observations, and the analysis population are also not described. Although 25 participants are listed for each mode, the record does not establish whether all participants contributed data to every outcome or how unavailable observations were handled.

Fourth, the reported outcomes concern one night. The registry's study description refers to sleep-unit and home phases, but the home-phase results and their relationship to the posted sleep-study outcomes are not detailed. The record also does not report a clinically meaningful threshold for the primary outcome, a multiplicity plan, the original sample-size justification, or a statistical analysis plan. These gaps limit assessment of precision, generalizability, and whether the displayed contrasts match the prespecified analysis.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Juno Perth Clinical Trial — NCT02317042.
• Registry record last updated 2021-06-08; status last verified 2021-05.
• Results first posted 2021-06-08.
• 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.

22. Record Summary

The registry record describes a randomized, triple-masked crossover study sponsored by ResMed, with enrollment of 25 and status recorded as terminated. It evaluates AutoEPAP iVAPS, FixedEPAP iVAPS, and Standard ST Mode using sleep-study measures, including AHI over 1 night.

The posted primary summaries show mean AHI values of 3.87, 3.57, and 4.09 events/hour, respectively. The reported unadjusted contrasts compare each iVAPS mode with Standard ST Mode; their confidence intervals include zero. A direct AutoEPAP-versus-FixedEPAP estimate is not reported in the registry record, despite that pair being named in the primary endpoint description.

Interpretation is limited by the small enrollment, one-night measurement period, unreported crossover-adjusted analysis, and missing detail on participant flow, missing data, multiplicity, and the reason for termination. The registry record does not establish equivalence or a clinically meaningful difference.