HHHFA in COPD Patients, With Chronic Bronchitis: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for HHHFA in COPD Patients, With Chronic Bronchitis (NCT03959982), a randomized na study. The primary outcome is Sleep Quality Using the PSQI Questionnaire.

2. Clinical Question

3. Trial Design

This was a randomized, parallel-group study with no masking. The registry lists an overall enrollment of 11 and a status of completed. The study start date is 2021-02-24, and the primary completion date is 2022-12-05. Its phase is listed as NA. The sponsor is Spyridon Fortis.

The study’s stated focus was HHHFA use during sleep among people with chronic obstructive pulmonary disease and chronic bronchitis. The brief summary describes the work as a pilot study and identifies respiratory symptoms, quality of life, sleep, lung function, and exercise capacity as clinically relevant short-term outcomes. The registry lists the primary endpoint as sleep quality using the PSQI, assessed at baseline and 6 weeks.

Participants assigned to HHHFA were to use the device at bedtime for at least 4 hours. The group description lists questionnaires, spirometry, a six-minute walk, and CT scans. The control group description lists questionnaires and the same tests, and says participants would wear a Spirehealth Device daily for 12 weeks. The record does not explain the control device’s role or how its 12-week use relates to the primary endpoint’s 6-week timeframe.

The record does not report the randomization procedure, concealment of allocation, eligibility criteria in sufficient detail, or the rationale for the planned enrollment. It also does not report a formal sample-size justification or a detailed statistical analysis plan. Those omissions limit how fully the design and the intended analysis can be assessed.

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:

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 Sleep Quality Using the PSQI Questionnaire, measured over Baseline and 6 weeks.

The primary endpoint is change in sleep quality from baseline to 6 weeks, measured using the Pittsburgh Sleep Quality Index (PSQI). The questionnaire collects information about usual sleep habits during the past month. Its scale ranges from 0 to 21, with higher scores indicating worse sleep quality. The registry defines positive change as worse sleep quality at 6 weeks; accordingly, a negative change indicates a lower score at follow-up than at baseline.

Sleep quality is relevant to the stated study objective because the research focuses on HHHFA use during sleep and the registry summary says its effect on sleep quality had not been studied. The PSQI provides a questionnaire-based measure that can be repeated over time. A change score describes the direction and size of within-group change, but it does not by itself establish whether change differs between randomized groups. That comparison requires an analysis of the groups’ outcomes, with its method and uncertainty described.

The registry identifies the summary measure as a median and the dispersion measure as an interquartile range. However, no interquartile-range value is available in the posted arm summaries. The record lists additional values alongside the medians, but does not define their statistical interpretation. Therefore, they should not be treated as a confidence interval or another specific uncertainty measure without clarification from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The statistical details posted for this study are limited. The design is randomized and parallel, and the primary endpoint is a change score summarized by the median. No analyses are listed in the registry record. The explanation below distinguishes what those posted summaries mean from general statistical principles; it does not infer an analysis that the record does not describe.

What does the median summarize?

The median is the central value when observations are ordered. Unlike a mean, it is not pulled as strongly by a very high or low observation. This can make it useful for measures whose distributions are skewed or include unusual values. A median alone does not describe how tightly or widely individual observations are distributed. The registry identifies the interquartile range as the dispersion measure for the endpoint, but a numerical interquartile range is not available in the posted arm summaries. Without a reported spread measure, the variation among participants cannot be read from the median alone.

The values -0.5 for HHHFA and 1.0 for control are median changes in the PSQI score, not median scores at follow-up. The endpoint description defines positive changes as worse sleep quality at 6 weeks. This gives the signs a direction, but it does not make the arm medians a direct estimate of the difference between treatment strategies. Separate medians do not necessarily combine into a valid estimate of a median treatment contrast.

What does a confidence interval usually convey?

General explanation: a confidence interval is a range constructed by a specified method to express uncertainty around an estimate. Its interpretation depends on the analysis and assumptions used. It is not simply a range containing most participant observations, and it is not interchangeable with an interquartile range. The record lists additional values with the arm summaries, but does not identify what those values represent. They cannot be given a confidence-interval interpretation on the posted information.

For a randomized comparison, an estimate of the between-group difference would ordinarily be accompanied by an uncertainty measure. That combination helps distinguish a potentially meaningful estimate from one too imprecise to resolve the direction or size of a difference. No such group contrast or uncertainty measure is reported for this endpoint. A p-value is also not reported. The lack of a posted test means the arm-level summaries should be read descriptively, not as a test of whether the intervention and control differed.

Why does the randomized design matter?

General explanation: random assignment is intended to make treatment groups comparable, on average, with respect to factors that can affect outcomes. In a completed trial, a properly defined between-group analysis uses the assigned groups to estimate the contrast of interest. Randomization does not remove the need to report how participants were analyzed, how missing outcomes were handled, or how uncertainty was quantified. The registry says allocation was randomized but does not report the randomization method, allocation concealment, or the statistical model for the endpoint.

The study was unmasked. This describes the design but does not, by itself, establish whether the PSQI responses were biased. Because the endpoint is questionnaire-based, the way assessments were administered and whether participants or assessors knew assignment can matter when interpreting self-reported outcomes. The record does not report additional procedures for reducing or assessing such effects.

What can be inferred from the endpoint counts?

The primary outcome summaries include 4 HHHFA participants and 3 control participants. These counts tell readers how many participants contribute to the posted arm summaries, but not why others enrolled in the study are absent from those summaries. The record does not provide participant flow, missingness reasons, or an analysis-population definition. General explanation: when outcome availability differs from the number randomized, the reasons and handling of missing observations are important because the analyzed participants may not fully represent all randomized participants. The record does not permit an assessment of that possibility.

How should sample-size planning be understood?

General explanation: a sample-size calculation is a planning exercise based on assumptions about the effect to detect, outcome variability, significance level, allocation, and analysis method. It is not evidence that a study had a particular probability of finding a result after the data are observed. The planning illustration described for this study uses a two-sided significance level of 0.05, equal allocation, a normal approximation, and effects expressed as fractions of the observed effect. The record does not report the trial’s own sample-size justification. Numerical planning outputs are not reported in the registry record, and no planning illustration should be mistaken for an observed analysis or observed power.

The registry also does not report interim analyses, the prespecified statistical test, adjustments for baseline scores, covariates, or any model for repeated measurements. These details are necessary to reproduce or evaluate an inferential analysis. Their absence does not show that a particular method was or was not used; it means the method is not reported in the registry record.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists a primary endpoint of sleep quality using the PSQI and lists two secondary outcomes: the six-minute walk and health-related quality-of-life change using the CAT questionnaire. The record also describes other measurements and questionnaires in the arm descriptions. However, it does not report a multiplicity strategy, such as how interpretation would account for testing several outcomes or timepoints. A prespecified hierarchy or adjustment method is not reported in the registry record.

No analyses are listed. The registry record does not state which statistical tests were planned or used, whether the primary outcome was analyzed according to randomized assignment, or how any baseline values were incorporated. It does not report an analysis population definition, such as an intention-to-treat population, or describe per-protocol analyses. These omissions mean the posted descriptive results cannot be matched to a stated inferential plan.

The overall enrollment is 11, while the primary endpoint summaries include 4 participants in the HHHFA group and 3 in the control group. The record does not describe participant flow, the number with missing PSQI assessments, reasons for missing data, or how missing outcomes were handled. It does not report whether participants with incomplete information were excluded, whether any imputation was used, or whether sensitivity analyses were performed. Those details are not reported in the registry record; no particular explanation should be assumed.

General explanation: missing outcome data can affect both the precision and the interpretation of a treatment comparison, especially when the reasons for missingness are related to participants’ outcomes or group assignment. Transparent reporting usually identifies the analysis population, outcome availability, and methods used to address missing observations. Without those details, readers cannot assess whether the small endpoint summaries reflect all randomized participants or whether the missing observations could alter interpretation.

11. 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 reports serious adverse events for 0 of 4 participants at risk in the HHHFA group and 0 of 3 participants at risk in the control group. It reports 0 deaths in each group. For other adverse events, it reports 0 of 4 participants at risk in HHHFA and 0 of 3 in control. No serious adverse-event terms are listed.

These figures describe what was recorded for the participants counted as at risk. They do not establish that no adverse events could occur, and they do not demonstrate equivalence in safety between groups. With small numbers at risk, an absence of recorded events provides limited information about the frequency or range of possible harms. The registry record does not provide additional detail on event definitions, collection procedures, follow-up completeness, or the duration over which these safety counts were assessed.

The distinction between serious and other adverse events matters: the posted figures report zero affected participants in both categories, but the record does not give event-level detail beyond the absence of listed serious-event terms. These counts should be read as descriptive safety reporting, not as a stand-alone comparison of risks or as a guarantee about future experience.

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

The posted primary results show a median PSQI change of -0.5 in the HHHFA group and 1.0 in the control group. Under the endpoint’s stated scoring direction, positive change indicates worse sleep quality at 6 weeks. These results describe the participants included in each arm summary. They do not establish whether HHHFA changed sleep quality relative to control, because the registry does not report a between-group estimate or statistical test.

The numbers are also not enough to judge the precision of a group difference. The endpoint is described as using a median and interquartile range, but numerical interquartile ranges are not available in the posted summaries. Additional values are listed alongside the arm summaries without an explanation of their statistical meaning. They should not be re-labelled as confidence intervals or used to make an inference about statistical significance.

The study is identified as a pilot, and the outcome summaries are based on 4 HHHFA participants and 3 control participants. The record does not explain why these endpoint counts are below overall enrollment, nor does it report missing-data methods or the analysis population. These limitations make it difficult to assess how well the summaries represent everyone enrolled or randomized.

The record does not support a claim that HHHFA improves or worsens sleep quality, or that it has no effect. Such conclusions would require a properly reported comparison and an assessment of its uncertainty, alongside clear information on outcome availability and analysis methods. The descriptive medians can be reported as the posted observations, while the uncertainty and comparative interpretation remain unresolved in the registry record.

The safety counts likewise show no reported serious or other adverse events among the participants listed as at risk, but the small counts and limited event detail do not establish comparative safety. Overall, the record documents a randomized pilot and descriptive endpoint results; it does not provide enough statistical reporting to make a firm inference about a difference between groups.

13. Why This Trial Matters Statistically

This trial raises an important statistical distinction between observing change within each group and estimating a difference between randomized groups. The registry reports median changes for HHHFA and control, but does not report a direct comparison. Readers can describe the posted arm summaries, yet cannot use them as a substitute for an estimated treatment contrast with quantified uncertainty.

The study also illustrates why outcome counts and dispersion matter. The primary summaries include 4 participants in one group and 3 in the other, while overall enrollment was 11. The record does not explain the difference in counts or provide a numerical interquartile range, despite naming that measure as the endpoint’s dispersion statistic. Without information on participant flow and variability, the stability and precision of the summaries are difficult to evaluate.

Because the primary endpoint is a questionnaire-based change score, clear reporting of scoring direction, follow-up timing, analysis population, and missing-data handling is particularly useful. The registry does specify that higher PSQI scores indicate worse sleep quality and that positive change means worse sleep quality at 6 weeks. That helps readers interpret the direction of the medians. It does not resolve the absence of an inferential comparison or the unexplained additional values.

For biostatistical interpretation, the record is a reminder that randomized allocation alone does not supply the full analysis. A transparent report also needs the planned comparison, the uncertainty around it, details about missing outcomes, and any approach to multiple outcomes. Those items are not reported in the registry record. The descriptive results and safety counts therefore support a limited account of what was posted, while leaving the comparative question open.

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 primary results are based on 4 HHHFA participants and 3 control participants, although overall enrollment was 11. The registry record does not explain the difference between enrollment and the endpoint counts, provide participant flow, or report reasons for missing endpoint data. The primary outcome is listed as a median with interquartile range, but the posted arm summaries do not include numerical interquartile ranges. Additional values are listed without an explanation of their statistical meaning.

No between-group analysis, p-value, effect estimate, confidence interval, or analysis method is reported. The record does not identify the analysis population, how missing outcomes were handled, or whether the reported summaries follow randomized assignment. It also does not report a sample-size justification, interim analyses, or a multiplicity plan. These gaps prevent assessment of the intended inferential framework and the precision of any comparative effect.

The registry describes an unmasked, randomized, parallel design. It does not report the randomization procedure or allocation concealment. The intervention and control descriptions include different device-use details: HHHFA at bedtime for at least 4 hours, and a Spirehealth Device worn daily for 12 weeks in control. The record does not clarify the control device’s purpose or its relation to the 6-week primary endpoint timeframe. It also does not report the extent of adherence to either device.

The safety counts are limited to the participants reported as at risk, and the registry provides no additional event-level detail for the listed categories. The small number of participants and limited reporting make the safety summaries descriptive rather than a precise comparison. These are limitations of what is reported in the registry record; they do not establish that unreported procedures or analyses were not performed.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: HHHFA in COPD Patients, With Chronic Bronchitis — NCT03959982.
• Registry record last updated 2024-09-19; status last verified 2024-08.
• Results first posted 2024-09-19.
• 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.

18. Record Summary

NCT03959982 is a completed, randomized, parallel-group study with no masking, listed under pulmonary disease, chronic obstructive. Overall enrollment was 11. The study examined HHHFA use during sleep in people with COPD and chronic bronchitis. Its primary endpoint was change in PSQI sleep-quality score from baseline to 6 weeks, where positive change indicates worse sleep quality.

The primary summaries report a median change of -0.5 among 4 HHHFA participants and 1.0 among 3 control participants. The registry does not report a statistical comparison between groups, numerical interquartile ranges, or an explanation of additional values listed with the summaries. It does not describe missing-data handling or the analysis population. No serious or other adverse events, or deaths, are reported among participants listed as at risk. The posted results are descriptive, and the registry record does not provide enough information to establish a comparative treatment effect.