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 Mandibular Advancement Device and Changes in Nocturia (NCT05562388), a na na study. The primary outcome is To Test MAD if Associated in Changes in Nocturia.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05562388 |
| Phase | NA |
| Condition | Obstructive Sleep Apnea, Nocturia, OSA |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 11 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Isabel Moreno Hay |
| Results posted | Yes |
2. Clinical Question
Population
Participants with obstructive sleep apnea and nocturia. The registry record lists 11 participants enrolled; further eligibility details and participant characteristics are not reported in the registry record.
Intervention
MAD therapy using the Somnodent Classic device. The registry record describes daily questionnaires about nighttime voiding and a follow-up assessment at 15 weeks.
Comparator
There is no separate control group. The study is recorded as single-group, with allocation listed as NA and masking listed as none.
Primary question
Is use of a mandibular advancement device associated with a change in nocturia, measured as episodes per night? The registry defines a responder as a participant achieving less than 2 voidings per night.
The question is about an association between MAD use and nighttime voiding, rather than a comparison of randomized treatment groups. The registry's primary outcome description says participants complete daily questionnaires. The average from the 2 preceding weeks of follow-up is intended to determine treatment success in terms of nocturia. A second sleep study is to be performed once the responder threshold is achieved.
A secondary outcome concerns the association between change in nocturia episodes and change in the apnea-hypopnea index, labeled “API” in the registry record. The record does not report numerical results for the primary or secondary outcome. It also does not report how many participants reached the responder threshold or whether the planned second sleep study was performed.
3. Trial Design
This is a completed, single-group study of MAD therapy. The registry lists an enrollment of 11 and names the Somnodent Classic as the device intervention. The study is not described as a randomized comparison: allocation is listed as NA, and the registry explicitly notes that there is no like-for-like control comparison. Masking is listed as none.
The registry lists obstructive sleep apnea and nocturia among the conditions. The primary outcome is described as the mean number of nocturia episodes per night, with standard deviation as the dispersion measure and a 15-week timeframe. Participants are to complete daily questionnaires about nighttime voiding. The average over the 2 preceding weeks of follow-up is intended for assessing treatment success. Once less than 2 voidings per night is achieved, a second sleep study is described as planned.
The study status is completed. The recorded start date is 2023-12-11, and the primary completion date is 2025-07-30. Phase is recorded as NA. The registry names Isabel Moreno Hay as sponsor.
A single-group design can describe the course of an outcome during treatment, but without a separate comparison group it cannot by itself distinguish a treatment-associated change from changes that might have occurred over time for other reasons. The registry record does not report a protocol rationale for choosing this design, a sample-size justification for the enrolled group, or details of how participants were selected. These details should not be inferred from the enrollment or the completed status.
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 | MAD Therapy |
|---|---|
| STARTED | 11 |
| COMPLETED | 11 |
| NOT COMPLETED | 0 |
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 | MAD Therapy |
|---|---|---|
| Participants analysed | 11 | |
| Age, Continuous | years | 50.36 (SD 12.86) |
| Sex: Female, Male: Female | Participants | 7 |
| Sex: Female, Male: Male | Participants | 4 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 11 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| 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 | 0 |
| Race (NIH/OMB): White | Participants | 11 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 11 |
6. Primary Endpoint
The registry lists the primary outcome as To Test MAD if Associated in Changes in Nocturia, measured over 15 weeks.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Episodes per night |
| Endpoint classification | Event-Rate Endpoint |
The primary endpoint is nocturia measured in episodes per night. The registry identifies the summary parameter as a mean and the dispersion measure as a standard deviation. Daily questionnaires are intended to capture nighttime voiding, and the average from the 2 preceding weeks of follow-up is specified for determining treatment success. The assessment timeframe is 15 weeks.
Counting episodes per night gives a direct description of the frequency being studied. A mean can summarize the group’s average number of episodes, while a standard deviation describes how much individual observations vary around that mean. These are descriptive summaries; neither, on its own, indicates how certain an estimated change is or whether changes differ from what might occur without treatment.
The registry also defines a responder threshold: less than 2 voidings per night. That threshold is distinct from the continuous mean endpoint. A responder count would describe how many participants met the specified criterion, while the mean would describe the group’s average episode frequency. The registry record does not report the observed mean, standard deviation, change from baseline, or number of responders. It also does not report the questionnaire scoring details or how incomplete daily entries were handled.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a clinically focused question and a planned way to measure nighttime voiding, but it does not report numerical primary outcome results. In particular, no baseline or follow-up mean, standard deviation, estimated change, confidence interval, or hypothesis-test result is reported in the registry record. The planned endpoint and responder definition therefore describe what the study intended to assess; they do not establish what was observed.
The study enrolled 11 participants and used a single-group design. That design can record outcomes during MAD therapy, but any before-and-after change would not have a concurrent control-group comparison. As a general statistical point, a change over time in one group can reflect multiple influences, including the intervention, natural variation, or other changes during follow-up. The registry record does not report information that would separate these possible explanations.
The responder definition is less than 2 voidings per night. The record does not state how many participants met that threshold, when they met it, or whether the second sleep study described in the outcome text took place. Without those results, the responder rule cannot be used to characterize observed response in this study. Likewise, the secondary outcome concerning change in nocturia and change in the apnea-hypopnea index is listed, but its numerical result is not reported in the registry record.
The adverse-event record lists 0 participants affected by serious adverse events among 11 at risk, 0 affected in the other-event fields among 11 at risk, and 0 deaths. These are the reported counts for this enrolled group; they do not estimate the frequency of events beyond the participants and reporting period recorded.
Overall, the registry record supports describing the design, planned endpoint, and recorded adverse-event counts. It does not support a numerical conclusion about the magnitude or precision of change in nocturia, nor a causal comparison with no MAD therapy. The completed status indicates the study is marked complete, not that the registry reports every planned outcome result.
9. Statistical Methods Explained
The registry specifies a mean number of episodes per night as the primary outcome summary and standard deviation as the measure of dispersion. A mean is the arithmetic average of observations. In this setting, it would summarize the average nighttime episode frequency in the group for the assessment period. A standard deviation describes the spread of participant observations around the mean. It is not the same as a confidence interval: the former describes variability among observations, whereas a confidence interval expresses uncertainty around an estimated quantity under the assumptions of the analysis.
The outcome description uses daily questionnaires and specifies that the average of the 2 preceding weeks of follow-up will determine treatment success in terms of nocturia. The endpoint is therefore described as an average over a period, not as a single night's observation. Repeated daily measurements can describe variation over time, but they also raise practical analysis questions. For example, the registry record does not report how missing questionnaire days were treated, whether all days had to be completed, or how the participant-level average was calculated if some entries were absent.
The responder criterion is less than 2 voidings per night. This is a threshold-based summary, different from a mean outcome. A threshold can make a result easier to interpret as the proportion or count meeting a prespecified definition, but it also reduces a range of episode counts to categories. The registry lists the criterion but does not report the number of responders or the method used to analyze that outcome. It does not say whether the threshold was established before study conduct or how it was handled for participants without complete diary information.
The registry calls the primary parameter MEAN and identifies standard deviation as dispersion. It does not report an analysis model, a method for estimating change, a confidence-interval method, or a hypothesis test. The presence of a mean endpoint does not establish whether the analysis compared follow-up with baseline, modeled repeated observations, or used another approach. Those details are not reported in the registry record and should not be inferred.
In general, a confidence interval is a range of values compatible with the observed data and an assumed statistical model, with its width reflecting precision. Wider intervals indicate greater uncertainty about the estimated quantity; narrower intervals indicate greater precision, conditional on the model and data. No confidence interval for the primary endpoint is reported in the registry record. A p-value, if reported, would address compatibility with a specified null hypothesis under the analysis assumptions; it would not measure the size or clinical importance of a change. No primary-outcome p-value is reported in the registry record.
The study is single-group, so there is no randomized control arm for a between-group treatment-effect estimate. A within-group change, if available, would be a description of change among participants and would not have the same interpretation as a randomized between-group contrast. General statistical reasoning also cautions that participants may change over time for reasons other than the intervention. Without a comparison group, those influences cannot be isolated solely by measuring before and after.
The registry includes planning assumptions for sample-size illustrations: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a stated fraction of the observed effect. The assumptions describe planning illustrations, not the design actually recorded for this single-group study. No sample-size illustration values or observed effect values are reported in the registry record summarized for this analysis. Such illustrations are planning quantities, not observed power, and should not be interpreted as evidence about the study's results.
The record lists 5 outcome measures and 1 analysis. Those counts do not identify the statistical methods, the analysis population, or whether all intended outcomes were analyzed. The registry also lists a secondary association between change in nocturia episodes and change in the apnea-hypopnea index, labeled “API.” The analysis method and numerical result for that association are not reported in the registry record. The record does not describe methods for over-dispersion, distributional assumptions, covariate adjustment, or handling of repeated measurements. General methods such as these matter only when the data structure and analysis plan warrant them; no particular method can be attributed to this study from the record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 5 outcome measures and 1 analysis. It does not report a multiplicity-adjustment plan, an ordering of outcomes, or which outcomes were designated as confirmatory. When multiple outcomes or analyses are considered, the chance of obtaining at least one apparently notable result can increase if each is interpreted separately. Statistical approaches to multiplicity can address that issue, but the registry record does not state that any particular approach was used. The listed outcome and analysis counts alone are not enough to determine how results were selected or interpreted.
Missing-data methods are not reported in the registry record. This is relevant because the primary outcome description relies on daily questionnaires and an average over the 2 preceding weeks of follow-up. The record does not say how incomplete diaries were handled, whether participants needed a minimum number of entries, or whether any imputation or sensitivity analysis was conducted. It also does not report missingness in the primary outcome or secondary outcome.
The analysis population is not reported in the registry record. Although enrollment is listed as 11, the record does not specify how many participants contributed evaluable primary outcome data, whether all enrolled participants were included in the analysis, or how withdrawals or protocol deviations were handled. The completed status does not resolve these questions. No assumptions about an intention-to-treat, per-protocol, or other analysis population should be made from the available description.
These omissions limit assessment of how robust any outcome estimate might be to incomplete data or analytic choices. They do not establish that data were missing or that an adjustment was needed; they mean the record does not describe the relevant details.
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 |
|---|---|---|---|
| MAD Therapy | 0 | 11 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| MAD Therapy | 0 of 11 |
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 |
|---|---|
| MAD Therapy | 0 of 11 |
The registry's serious adverse-event fields list 11 participants at risk and 0 affected in the MAD Therapy group. The other-event fields also list 11 at risk and 0 affected. Deaths are listed as 0, and no serious-event terms are listed.
These are reported counts for the registry record, not proof that adverse events are impossible or that no events occurred outside the record's reporting scope. The record does not provide event definitions, details of the safety-monitoring period, or a narrative account of how events were collected. It also does not report a separate comparison group for interpreting these counts. With 11 participants enrolled, the counts describe the recorded experience of this study group only.
A zero count should therefore be read literally as zero affected participants recorded in these categories, not as a guarantee of no risk. The registry record does not report further safety analyses or event-level details.
12. What the Result Does, and Does Not, Mean
The study addresses whether MAD use is associated with changes in nocturia and specifies an episode-per-night outcome, a 15-week timeframe, and a responder criterion of less than 2 voidings per night. It records a completed single-group study with 11 participants. These registry entries describe the study’s question and design, but the registry record does not report the numerical primary outcome results needed to judge the observed change or its precision.
The available description does not show how the group’s mean episode frequency changed, how variable participant outcomes were, or how many participants met the responder criterion. It also does not report a numerical result for the secondary association between change in nocturia and change in the apnea-hypopnea index. As a result, the outcome descriptions cannot be treated as evidence that a particular change was observed.
Even if a within-group change were reported, a single-group design would not provide a concurrent control comparison. In general, that means the change could not be attributed to the device alone from the design itself. Differences over time may have other explanations, and the registry record does not describe a method that would isolate those effects.
The record also lists 0 serious adverse events, 0 participants affected in the other-event fields, and 0 deaths. These counts describe what the registry records for this study; they do not establish that the device has no safety risks in other settings or participants. The study’s enrollment and the absence of event details limit broader interpretation.
The most defensible reading is therefore descriptive: the registry records a completed study intended to examine nocturia during MAD therapy, with a specified questionnaire-based endpoint and responder definition. It does not report enough outcome data to quantify a change, assess its precision, or support a causal conclusion. No treatment recommendation follows from the registry information.
13. Why This Trial Matters Statistically
This study is statistically notable for the gap between a clearly stated clinical measurement and the absence of numerical outcome results in the registry record. The primary outcome is described as mean episodes per night, with standard deviation, and the assessment period and responder threshold are specified. Those details identify what an analysis would need to summarize, but they do not reveal the observed result.
The single-group design also makes the estimand important. A change within the MAD therapy group would describe participants over time; it would not, by itself, estimate how outcomes differ from what would have happened under a comparator condition. This distinction is central when interpreting intervention studies. The registry explicitly records no randomized comparison, so claims based on a control-group contrast are not supported by the design described.
The daily questionnaire approach raises further statistical considerations. Participant averages depend on how repeated entries are combined and how incomplete entries are treated. The registry does not report those rules. The responder threshold gives a second way to describe outcomes, but a threshold-based summary and a mean answer different questions. Reporting both with clear methods and uncertainty would help readers understand how the endpoint was operationalized and how consistently participants met the stated criterion.
Finally, the record illustrates why completion status, outcome definitions, and outcome results should be distinguished. A study marked completed has reached that registry status, but the record still does not report numerical primary results or the analysis details needed to evaluate precision and robustness. The listed adverse-event counts are also descriptive and should be interpreted within the enrolled group rather than generalized beyond it.
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 statistical interpretation is that the registry record does not report numerical results for the primary endpoint. No observed mean, standard deviation, change estimate, confidence interval, or primary-outcome test is reported. The responder count is also absent. The intended endpoint can therefore be described, but not quantitatively interpreted.
The single-group design has no separate control arm. A change during follow-up could not be separated from other time-related influences using a concurrent randomized comparison in this study design. The registry’s allocation and masking entries are NA and none, respectively, and the record does not describe further procedures that would address this limitation.
The enrollment is 11. The registry record does not report participant characteristics, eligibility details, the number with evaluable outcomes, or whether any participants withdrew. Generalizability and the effect of any incomplete follow-up therefore cannot be assessed from the record. This is especially pertinent to the daily questionnaire outcome, for which missing-entry rules are not reported.
The record does not report the statistical analysis method, analysis population, multiplicity plan, or sensitivity analyses. It also does not provide details of the secondary outcome analysis or whether the described second sleep study was performed after the responder threshold was met. These absences prevent evaluation of analytic choices and completeness of outcome reporting.
Safety reporting is limited to the recorded counts: no affected participants are listed in the serious-event or other-event fields, and deaths are listed as 0. Event definitions, monitoring details, and event narratives are not reported. These limitations are specific to what the registry record documents and should not be filled by assumption.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Mandibular Advancement Device and Changes in Nocturia — NCT05562388.
- Registry record last updated 2026-08-27; status last verified 2026-08.
- Results first posted 2026-08-27.
- 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
NCT05562388 is a completed, single-group study titled “Mandibular Advancement Device and Changes in Nocturia.” The registry lists 11 participants, MAD therapy with the Somnodent Classic device, and a 15-week primary outcome timeframe. Allocation is recorded as NA and masking as none.
The primary outcome is mean nocturia episodes per night, with standard deviation as the dispersion measure. Daily questionnaires are described, with the average of the 2 preceding weeks of follow-up used to determine treatment success. The responder criterion is less than 2 voidings per night. A secondary outcome concerns change in nocturia and change in the apnea-hypopnea index.
The record lists 5 outcome measures and 1 analysis. It reports 0 serious adverse events, 0 affected participants in the other-event fields, and 0 deaths. Numerical primary outcome results, analysis details, and missing-data methods are not reported in the registry record.