Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients (NCT03473548), a non-randomized na study. The primary outcome is Greater Than or Equal to 6 Hours of Sleep Data.

2. Clinical Question

The clinical question combines feasibility with measurement comparison. Feasibility asks whether the home device produced data sufficient for the intended analysis. The comparison asks whether measurements from home and laboratory procedures align or differ. Those are related but distinct questions: successful data collection does not by itself establish agreement between measurement settings.

The registry also lists McGill Oximetry Score among secondary outcomes. It does not report outcome values, participant-level paired observations, or an estimate of agreement between procedures. The record therefore identifies what investigators intended to examine, but it does not establish the size or precision of any difference in AHI or oxygen saturation measurements.

3. Trial Design

This was a completed, non-randomized, single-group study with no masking. The registry records 11 enrolled participants and identifies a portable sleep monitor as the device intervention. The comparison procedure was in-laboratory polysomnography. The record describes all eligible participants as being asked to complete an unattended overnight study at home before undergoing laboratory polysomnography.

Because the home study was conducted first for all participants, the sequence was fixed rather than randomized. This means the design is not a randomized comparison of separate treatment groups. The same participants were intended to undergo both procedures, but the registry record does not report how many completed each procedure or contributed paired results to each comparison. It also does not report whether the stated order could affect the measurements.

The study dates recorded are a start date of 2017-12-28 and a primary completion date of 2019-10-14. The overall status is completed. These dates describe the registry record; they do not give information about the timing of individual assessments or the duration between procedures.

The study's stated purpose was to assess feasibility and compare AHI, average SPO2, and SPO2 nadir between unattended home and in-laboratory polysomnography. The listed secondary outcomes also include McGill Oximetry Score. The registry record does not report a detailed statistical analysis plan, the intended comparison method, a sample-size justification, or whether any interim analyses were planned. It records no analyses in the available analysis count. That absence limits what can be said about how the investigators planned to turn the collected measurements into estimates.

The single-group structure is appropriate to describe as a within-participant measurement comparison in intent, rather than as a controlled trial of two independent groups. However, the available record does not confirm complete paired data or describe how incomplete or technically inadequate studies were handled. The reported feasibility result is a count, not a randomized treatment effect.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Only 1/10 participant had \> 6 hours of collected data on the Home Polysomnography

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: Subjects were identified from patients presenting to the Washington University in St. Louis Pediatric Otolaryngology Clinic who are suspected of having sleep disordered breathing. All 10/11 participants completed an in lab polysomnography.

6. Primary Endpoint

The registry lists the primary outcome as Greater Than or Equal to 6 Hours of Sleep Data, measured over greater than or equal to 6 hours.

The primary endpoint is the count of participants whose unattended home study produced at least 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index. The endpoint addresses whether the home recording was usable for the stated diagnostic measurement, rather than whether the monitor changed a clinical outcome.

Feasibility is useful because a measurement method cannot support its intended comparison when it fails to collect interpretable data. A count gives a direct description of how often the stated data-adequacy criterion was met in the participants represented by that outcome. It does not, on its own, explain why a recording was inadequate, whether data quality varied, or whether the result would be similar in a different group.

There is a wording distinction in the registry record: the endpoint title and description refer to at least 6 hours, while the reported population statement says that only 1/10 participant had more than 6 hours of collected data. The record does not clarify whether these formulations refer to exactly the same threshold or why the outcome denominator is 10 when enrollment is 11. That distinction should be kept in mind when interpreting the count.

The listed AHI and oxygen saturation measures address comparison between home and laboratory procedures, but those values are not reported in the registry record. The feasibility endpoint therefore cannot substitute for evidence about the agreement or precision of those measurements.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The primary outcome is a participant count, not a continuous measurement such as AHI or SPO2. It asks whether an individual home recording met a stated data-adequacy criterion. The registry reports the count in the form 1/10 participant with more than 6 hours of collected data. Counts are straightforward to describe, but their interpretation depends on a clear denominator, a consistent criterion, and transparent handling of records that are missing or unusable. The registry gives an enrollment of 11 but does not explain why the feasibility result uses 10 participants.

What does the feasibility count measure?

The endpoint connects technical data collection with the planned analysis: data must be adequate for polysomnography analysis and for determining AHI. The registry description refers to at least 6 hours of adequate data, while the reported population statement refers to more than 6 hours of collected data. Those phrases may not define the same boundary, and the record does not clarify how the criterion was applied. It also does not report how many recordings were attempted, why any recording did not meet the criterion, or whether other quality checks were used.

In general, a feasibility count can be reported as a proportion of participants meeting a prespecified criterion. Any such proportion is only interpretable when the numerator, denominator, and criterion are clear. No additional calculation is needed to understand the posted count, and no confidence interval is reported. In general, a confidence interval communicates the range of values compatible with the observed data under the chosen statistical method; it would also make uncertainty around a small-sample estimate visible. The registry record does not report one for this outcome.

How should the intended comparison be understood?

The stated comparison involves AHI, average SPO2, and SPO2 nadir measured with home and in-laboratory polysomnography. Since participants were intended to undergo both procedures, the natural data structure would be paired measurements: each person's home result could be compared with that person's laboratory result. The registry does not report whether every participant completed both assessments, which participants contributed to each outcome, or what statistical method was used. It is therefore not possible to identify an actual analysis from the posted record.

In general, paired analyses use information about within-person differences rather than treating measurements from the same person as independent. A mean difference can describe the average direction and size of differences for a continuous measure, while a confidence interval can indicate precision. Agreement methods can address whether individual measurements are close enough for a particular purpose; correlation alone, in general, measures association and does not demonstrate agreement. These are general statistical concepts, not methods confirmed as having been used in this study. No estimates or agreement analyses are reported in the registry record.

AHI is a quantitative measure named in the study description, while oxygen saturation outcomes include an average and a nadir. A nadir represents a low observed value, so its distribution and the meaning of its paired difference may not be the same as for an average. In general, analysts should examine the scale and distribution of each outcome before choosing a summary or model. The record does not state whether the measures were summarized with means, medians, differences, or another approach.

What do the analysis and planning details establish?

The registry records 0 analyses. It does not report p-values, confidence intervals, effect estimates, a statistical model, or a detailed statistical analysis plan. The absence of these items means the intended comparisons cannot be evaluated for method, precision, or prespecified interpretation from the available record. It does not establish that no analyses were performed outside the registry.

The registry's planning illustrations are described as calculations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They describe the effect to detect as a stated fraction of the observed effect. These are planning assumptions, not the reported design of this trial, which was single-group and non-randomized. The illustrations are not a sample-size justification for the study, and they are not observed power. In general, sample-size planning estimates how many participants might be required under chosen assumptions; it cannot replace an uncertainty interval around an observed result or establish that a study was adequately designed.

Over-dispersion is a general issue for count outcomes when variability exceeds what a simple count model would expect. It can lead to uncertainty estimates that are too narrow if the model fails to account for that extra variability. The primary outcome is reported as a participant count, but the registry record does not report a model, a dispersion estimate, or any count-model analysis. This concept therefore explains a possible modeling consideration, not a feature confirmed for this analysis.

10. Exact Estimates for Each Arm

No two-arm comparison is shown for this trial, but each arm's result can still be summarized with exact interval estimates computed from the posted counts. The Clopper-Pearson interval is exact and conservative; the Wilson interval is a common closer-to-nominal alternative; the Bayesian credible interval uses a uniform Beta(1, 1) prior. For small groups the three can differ noticeably.

R code and output

arm    <- c("Portable Sleep Monitor")
n      <- c(1)
events <- c(1)
for (i in seq_along(n)) {
  ci <- binom.test(events[i], n[i])$conf.int          # Clopper-Pearson exact interval
  cr <- qbeta(c(0.025, 0.975), 1 + events[i], 1 + n[i] - events[i])   # Bayesian, uniform Beta(1,1) prior
  wi <- (function(x, n) { p <- x / n; z <- qnorm(0.975); d <- 1 + z^2 / n
    c((p + z^2 / (2 * n) - z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d, (p + z^2 / (2 * n) + z * sqrt(p * (1 - p) / n + z^2 / (4 * n^2))) / d) })(events[i], n[i])
  cat(sprintf("ARM|%s|%d|%d|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f|%.1f\n", arm[i], n[i], events[i], 100 * events[i] / n[i],
              100 * ci[1], 100 * ci[2], 100 * wi[1], 100 * wi[2], 100 * cr[1], 100 * cr[2]))
}

ARM  Portable Sleep Monitor  1  1  100.0  2.5  100.0  20.7  100.0  15.8  98.7

11. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary feasibility outcome and secondary outcomes that include AHI Score, SPO2 Result, SPO2 Nadir, and McGill Oximetry Score. The study description also names comparisons of AHI, average SPO2, and SPO2 nadir. Multiple outcomes create a multiplicity question: when several outcomes are examined, the chance of at least one apparently notable result can increase if each is assessed separately. In general, investigators may address this through a prespecified primary outcome, adjustment procedures, or a clear emphasis on estimation and uncertainty.

The registry record does not report a multiplicity strategy or clarify how the listed secondary outcomes relate to the described comparisons. It does not report p-values or comparative results for those outcomes. No conclusion about whether adjustment was used can be drawn from the record; the method is not reported in the registry record.

Missing-data handling is also not reported in the registry record. In particular, the record does not explain why enrollment is 11 while the feasibility result is reported for 10 participants, whether any participant lacked a home recording, or how incomplete recordings were classified. It does not state how missing home or laboratory measurements would enter the comparisons. A missing or technically inadequate recording is not automatically equivalent to an outcome below a threshold; the treatment of each case depends on the study's definitions and analysis plan, which are not reported.

The analysis populations are not described. The registry record does not say whether results were intended to include all enrolled participants, only those who completed both procedures, or another defined group. It also does not identify how exclusions or protocol deviations were handled. These omissions matter because the denominator and participant set determine which experience the reported count represents and how comparable home and laboratory measurements can be interpreted.

12. Safety Results

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

Deaths

Other (non-serious) adverse events

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

The registry lists 11 participants at risk for serious adverse events and reports 0 serious adverse events affected. It also lists 11 participants at risk for other adverse events and reports 0 other adverse events affected. Deaths are reported as 0. The adverse-event group is titled Portable Sleep Monitor, and no top serious event terms are listed.

These figures describe what was entered in the registry for the stated group and follow-up record. They do not establish that no events occurred outside the recorded definitions or reporting period, and they do not show how adverse events were sought or classified. The registry record does not provide additional detail about event definitions, monitoring procedures, or the length of safety follow-up.

A count of 0 is not the same as proof that risk is absent. In general, safety counts are interpreted in light of the number of participants observed, how long they were followed, and how completely events were collected. The record does not provide person-time or further context for those considerations. These figures should therefore be read narrowly as the reported adverse-event counts, not as a broad safety conclusion.

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

The posted feasibility result is limited and specific: the registry says that only 1/10 participant had more than 6 hours of collected data on home polysomnography. The result concerns the home recording's duration, as described in the registry, rather than a direct clinical benefit or a treatment effect. The endpoint's title and description use a threshold of at least 6 hours, while the posted result says more than 6 hours. The record does not resolve that wording difference or explain the denominator of 10 alongside enrollment of 11.

The study's other central aim was to compare AHI, average SPO2, and SPO2 nadir across home and laboratory procedures. The registry record does not report those comparative results, so it does not show whether the measurements agreed, how large any difference was, or how precisely that difference was estimated. McGill Oximetry Score is listed as a secondary outcome, but its result is also not reported in the registry record.

The study was non-randomized and single-group, with the home recording intended to occur before the laboratory procedure. It therefore cannot be described as a randomized comparison of separate groups. Its design and posted feasibility count address whether a home recording could yield the specified amount of data in the reported participants; they do not, by themselves, establish generalizability to other settings or populations.

In general, a result's meaning depends on the outcome definition, the analysis population, missing data, and uncertainty. Here, the registry does not provide a confidence interval, statistical analysis, detailed participant flow, or reasons for incomplete data. The available record supports reporting the stated count and the design features, while leaving the comparative measurement question unresolved. It does not establish that either procedure is superior or inferior, nor does it support medical advice.

14. Why This Trial Matters Statistically

This study is statistically interesting because it asks two different questions that are often conflated: can a home device collect usable data, and do measurements from that device compare adequately with laboratory measurements? Feasibility is a prerequisite for evaluating measurements, but it is not evidence of agreement. Keeping these aims distinct helps prevent a technical completion count from being interpreted as a validation result.

The paired-measurement intent also matters. When each participant is assessed by both methods, comparisons should account for the fact that two measurements from one person are related. In general, treating paired values as independent can misrepresent uncertainty. The registry record does not report a paired analysis or any estimates, making it impossible to assess whether that design feature was reflected in the analysis.

The record also illustrates why denominator clarity is central to a small feasibility study. Enrollment is 11, while the reported result uses 1/10 participant. A reader needs to know who is represented in the outcome and what happened to anyone outside its denominator. The registry does not explain this. The criterion is also phrased as at least 6 hours in the endpoint description and more than 6 hours in the posted result, making the exact threshold worth clarifying.

Finally, statistical interpretation requires more than a count or a list of intended outcomes. Comparative estimates and their uncertainty are needed to judge how informative the measurements are. The absence of those results in the registry record makes the study a useful example of the distinction between a stated research question and the evidence available to answer it.

15. 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 of the posted evidence is that the registry reports only a feasibility count, not results for the intended comparisons of AHI, average SPO2, or SPO2 nadir. McGill Oximetry Score is listed as a secondary outcome without a result. Consequently, no estimate of difference, agreement, or precision can be evaluated from the registry record.

The reported feasibility denominator is 10, while enrollment is 11. The record does not explain this difference, identify the participants who contributed to the outcome, or describe any exclusions. It also uses different wording for the duration criterion: at least 6 hours in the endpoint description and more than 6 hours in the result. These details make the exact interpretation of the count uncertain.

The registry describes a non-randomized, single-group design in which the home study was to precede laboratory polysomnography. It does not report completion rates for each procedure, paired measurement availability, reasons for unusable recordings, or the interval between assessments. Without those details, readers cannot judge the extent of within-participant data or how missing observations may affect comparisons.

The statistical analysis plan, sample-size justification, outcome-specific analysis methods, and multiplicity approach are not reported in the registry record. Nor are confidence intervals or other uncertainty measures. The safety entry reports no adverse events, but detailed definitions and follow-up context are not reported. Together, these limitations mean the available record is insufficient to assess the precision, generalizability, or comparative measurement performance of the procedures.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Feasibility of Unattended Home Polysomnography and Comparison to In-laboratory Polysomnography in Pediatric Patients — NCT03473548.
• Registry record last updated 2024-02-07; status last verified 2024-01.
• Results first posted 2024-02-07.
• 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.

19. Record Summary

The registry describes a completed, non-randomized, single-group study of unattended home polysomnography compared with in-laboratory polysomnography in pediatric patients. Enrollment was 11. Participants were intended to complete the home study before the laboratory procedure. The primary outcome concerned obtaining adequate data for AHI determination, with a stated duration threshold of at least 6 hours.

The posted feasibility statement says only 1/10 participant had more than 6 hours of collected home data. The registry does not explain the denominator difference or the threshold wording. Comparative results for AHI, average SPO2, SPO2 nadir, and McGill Oximetry Score are not reported in the registry record. The record reports 0 serious adverse events, 0 other adverse events, and 0 deaths among the listed group.

The registry does not report an analysis method, uncertainty estimates, missing-data procedures, or a multiplicity plan. The available result is therefore descriptive and does not resolve the intended comparison between home and laboratory measurements.