Sleep Device Testing to Promote Sleep in Infants: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sleep Device Testing to Promote Sleep in Infants (NCT05078112), a na na study. The primary outcome is Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary.

2. Clinical Question

The clinical question is whether a sensor-based device intended to promote sleep continuity is associated with a change in infant nighttime awakenings across the study’s pre- and post-intervention measurement periods. The registry describes parents recording awakenings on the 5 days immediately before the intervention and on the 5 days immediately after it. The device intervention takes place during the 20 days between those measurement periods.

This is a within-study time comparison, not a comparison with an untreated or alternative-treatment group. It can describe whether the recorded measure differs after device use, but by itself it cannot separate a device-associated change from other influences that may occur over time. The registry record does not report eligibility criteria beyond the infant population and the listed condition, nor does it report a separate comparator or a randomized allocation.

The primary question concerns the average number of awakenings per night, rather than a broader judgment of sleep quality or caregiver experience. The record also lists changes in the Brief Infant Sleep Questionnaire - Short Form score, Caregiver Epworth Sleepiness Scale score, and Patient Health Questionnaire-2 score as secondary outcomes. The clinical question should therefore be read narrowly: the primary endpoint is a parent-diary count averaged across specified days, and the registry record does not report the result of that endpoint.

3. Trial Design

The registry record identifies NCT05078112 as a completed study titled “Sleep Device Testing to Promote Sleep in Infants.” Duke University is listed as the sponsor. The study is classified as single-group, with allocation listed as NA and masking listed as none. It is not a randomized comparison, and the record does not describe a parallel control arm. The registry lists enrollment of 19.

The intervention is named Sleep sensor technology and classified as a device. Its description states that infants will use the device during sleep for 20 days. The primary outcome compares parent-reported nighttime awakenings at baseline with awakenings in the period after intervention. Baseline is based on the 5 days immediately before intervention; post-intervention measurement is based on the 5 days immediately following it. The comparison is therefore across time periods within the study, rather than between separate treatment groups.

The listed condition is chronic insomnia. The brief summary frames the study around technology using sensors to help infants learn self-soothing, but the registry record does not provide further protocol details about device operation, adherence, or how use was monitored. The primary completion date is 2022-07-31, the start date is 2021-10-20, and the overall status is completed. The phase is listed as NA.

Four outcome measures and one analysis are recorded. The primary measure is change in the mean number of nighttime awakenings per night, with standard deviation as the stated dispersion measure. The registry also lists three secondary score changes. It does not report a detailed statistical analysis plan, the analysis population, or whether the outcome analysis accounted for repeated measurements or other covariates. Those details should not be inferred from the single-group design or the stated outcome summary.

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

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 Change in Number of Nighttime Awakenings Per Night as Measured by Parent Sleep Diary, measured over Baseline to 5 days post-intervention.

The primary endpoint is change in the number of nighttime awakenings per night, measured using parent sleep diaries. Parents recorded awakenings during the 5 days before device use and the 5 days immediately following the intervention. The registry describes averaging the recorded nightly counts across each measurement period, then comparing the baseline average with the post-intervention average. The intervention itself is described as lasting 20 days.

This endpoint turns a sequence of nightly observations into a continuous summary for each measurement period. Reporting a mean expresses the average number of awakenings per night in the period; the standard deviation describes how dispersed the recorded values are around that mean. A change measure can then describe the difference between the pre- and post-intervention summaries, although the registry record does not report the numerical change or its direction.

Parent diaries are the stated source for this outcome. The endpoint is useful for examining a specific, observable aspect of sleep continuity, but it represents parent-reported awakenings rather than an independently measured sleep signal. The registry record does not report information about diary completion, validation procedures, or how missing diary days were handled.

The endpoint should not be interpreted as a complete assessment of infant sleep or caregiver well-being. The registry lists separate secondary measures for infant sleep questionnaire scores and caregiver sleepiness and mood symptoms. No primary endpoint result, uncertainty interval, or inferential test result is reported in the registry record, so the size and precision of any observed change cannot be assessed from the record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies the primary measure as continuous, summarized by a mean and standard deviation. These choices describe different features of the outcome: the mean locates the average, while the standard deviation describes the spread of measurements around that average. Neither summary alone shows the full distribution of awakenings, and neither indicates how accurately a change has been estimated. The record does not report the numerical mean or standard deviation values for the primary endpoint.

What does a pre-post comparison estimate?

In general, a pre-post analysis compares measurements from one group at different times. Here the recorded baseline period is the 5 days immediately before intervention, and the post-intervention period is the 5 days immediately after it. The device-use interval is described as 20 days. A change calculated from these periods would represent a difference in the measured averages across time. It would not, on its own, estimate a contrast against what would have happened over the same period without the device.

The registry record does not say whether the analysis used each infant’s paired period summaries, a group-level contrast, or another model. Pairing can be useful when the same individuals contribute measurements at both times because it accounts for within-person correspondence. But the statistical method used cannot be assumed from the schedule alone. The record also does not state whether covariates were included or how any variation in diary completion was addressed.

What does the standard deviation describe?

In general, the standard deviation describes how spread out observations are around their mean. It is not the same as a standard error, which describes uncertainty in an estimated mean, and it is not a confidence interval. For repeated nightly counts, variation may occur across nights and across infants. The registry’s brief description says nightly awakenings are averaged across each 5-day period, but it does not provide enough detail to determine how the reported standard deviation was calculated or which analysis-level observations it summarizes.

Count outcomes can sometimes show more variability than a simple statistical model expects. In general, over-dispersion means the observed variability exceeds the model’s assumed variability; if ignored, uncertainty estimates can be too small. That is a general consideration for count data, not a claim that over-dispersion occurred in this study. The record describes the primary outcome as a mean with standard deviation and does not report a count model, a distributional assessment, or a method for handling over-dispersion.

How should uncertainty be assessed?

In general, a confidence interval gives a range of values compatible with the data and the method used, and its width conveys precision. A p-value, when reported, measures how incompatible the data are with a specified null model under the assumptions of the test; it does not measure the size or clinical importance of an effect. The registry record reports neither a confidence interval nor a p-value for the primary endpoint. It also does not report a standard error or other numerical estimate of uncertainty. Accordingly, the precision and statistical evidence for a change cannot be evaluated from this record.

The study record includes planning assumptions for a separate sample-size illustration: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. These are planning assumptions, not a description of the study’s single-group design. The record does not provide the numerical planning results in the registry record for this analysis, and the illustration should not be read as observed power. Sample-size calculations based on an observed effect are planning illustrations; they do not establish the probability that this completed study detected an effect.

More broadly, a statistical test or interval would depend on the analysis population, outcome distribution, missing-data handling, and model. The registry record does not report these details. It also does not state whether there were interim analyses or provide a full statistical analysis plan. Those features should not be filled in by assumptions based on common practice.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Sleep Device Intervention")
n   <- c(19)
m   <- c(-0.88)
sp  <- c(0.89)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Sleep Device Intervention  19  -0.880  0.890  -1.309  -0.451

11. Multiplicity, Missing Data and Analysis Populations

The registry lists the primary change in nighttime awakenings and three secondary score changes: the Brief Infant Sleep Questionnaire - Short Form, the Caregiver Epworth Sleepiness Scale, and the Patient Health Questionnaire-2. It records four outcome measures and one analysis. These entries identify several outcomes of interest, but the registry record does not explain how the analysis count relates to the outcome measures or which outcomes were included in that analysis.

When several outcomes are assessed, the chance of at least one apparently notable result can increase if each is tested separately. In general, multiplicity procedures can address that issue by defining a primary outcome, adjusting inference across tests, or using another prespecified strategy. The registry record does not report a multiplicity adjustment, a hierarchy for secondary outcomes, or the inferential results for the listed measures. No adjustment method should be presumed.

The registry record also does not report missing-data counts, diary completion, reasons for missing measurements, or the method used to handle missing outcomes. It does not state an analysis population, such as whether the primary analysis included all enrolled infants or only those with measurements at both time points. The enrollment entry is not enough to determine the number contributing to an outcome analysis.

These omissions matter because missing outcome data can affect both the estimated change and its uncertainty, depending on the amount and pattern of missingness and the analysis approach. In general, analyses relying only on complete records may differ from analyses using an explicit missing-data model. No particular pattern or method can be inferred for this study. The registry record does not report interim analyses, a detailed statistical plan, or additional analysis-population definitions.

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’s safety entries list the Sleep Device Intervention group with 19 at risk for serious adverse events and 0 affected. The entry for other adverse events also lists 19 at risk and 0 affected. Deaths are recorded as 0. These are the reported figures for the listed group; the record does not provide serious adverse-event terms.

A count of zero recorded events is a description of what the registry reports, not proof that an event is impossible or that the device has no safety risks. It does not establish how events were defined, actively sought, reviewed, or attributed. The registry record does not provide those details, and it does not report further context about follow-up completeness or the process for adverse-event collection.

The safety figures should also be read separately from the primary sleep outcome. They do not show whether nighttime awakenings changed, and the registry record does not report the primary outcome result. Conversely, an outcome change would not itself characterize safety. The figures describe recorded events in the intervention group, without a separate control group for comparison. No rate comparison or causal safety conclusion can be drawn from these entries alone.

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

The registry record establishes the study’s question, design, intervention schedule, and stated primary measurement. It describes a completed single-group study in which parent diaries were used to compare average nighttime awakenings before and after a 20-day device intervention. It also lists secondary measures addressing infant sleep questionnaire scores and caregiver sleepiness and mood symptoms.

The record does not report numerical results for the primary or secondary outcomes. As a result, it does not show whether the measured outcomes changed, the size or direction of any change, or the precision of an estimate. No confidence interval or p-value is reported for the primary endpoint. The outcome description and enrollment entry cannot substitute for those results.

Even if a pre-post change were available, the single-group design would not provide a concurrent estimate of change in the absence of the device. In general, a measured difference over time may reflect the intervention, other time-related influences, or measurement variation. This design can describe what happened across the study periods, but it cannot isolate a device effect as a randomized, controlled comparison would aim to do.

The primary endpoint is also specific: it concerns parent-reported nighttime awakenings averaged across defined diary periods. It is not, by itself, a comprehensive measure of sleep, a direct measure of self-soothing, or an assessment of all caregiver outcomes. The secondary outcomes are listed, but their results are not reported in the registry record.

Accordingly, the registry record supports a cautious account of the study’s structure and intended measurement, not a conclusion that the device did or did not change infant sleep. It also cannot establish the magnitude, clinical importance, or cause of any change. Those questions require outcome estimates and analytic details that are not reported in the registry record.

14. Why This Trial Matters Statistically

This study illustrates how a clinical question and an outcome measure must be read alongside the design that generated them. The primary endpoint is a mean of diary-recorded awakenings before and after device use. That comparison may describe change over time, but the single-group structure means it is not a randomized contrast against a control condition. Statistical interpretation depends on recognizing that distinction before considering any estimate.

The record also shows why outcome reporting needs more than a measure name and an enrollment entry. To judge a change, readers need the baseline and post-intervention summaries, the estimated contrast, and information about uncertainty. To assess whether the result applies to the intended analysis population, readers need to know who contributed outcome data and how missing observations were treated. These results and details are not reported in the registry record.

The study’s diary-based endpoint is concrete and linked to the stated aim of sleep continuity, while its secondary measures broaden the focus to infant sleep questionnaire scores and caregiver outcomes. However, multiple outcomes raise questions about prioritization and multiplicity. The registry record lists four outcome measures and one analysis but does not explain the analysis strategy or how inference across outcomes was handled.

These are statistical issues, not judgments about whether the intervention is valuable. Clear reporting of design, estimates, uncertainty, missingness, and analysis methods allows readers to distinguish a descriptive change from evidence of a causal effect. In this record, the design and measurement schedule can be described, but the absent outcome results and analytic details limit what can be concluded.

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.

Several limitations follow directly from the registry information. The study is listed as single-group, with no randomized allocation and no separate control arm. Consequently, a pre-post difference, if reported, would not by itself distinguish an intervention-associated change from changes over time or other influences. The record does not describe masking; masking is listed as none.

The primary endpoint depends on parent sleep diaries. The record does not report diary adherence, validation details, or how incomplete diaries were handled. Because the outcome is averaged over specified pre- and post-intervention periods, missing diary days could affect the summaries, but the amount and treatment of missing data are not reported in the registry record.

The registry lists enrollment of 19, but does not report the number included in the primary analysis or define an analysis population. It also does not report the numerical primary outcome estimate, its uncertainty, or the secondary outcome results. This prevents assessment of direction, magnitude, precision, and consistency across measures.

Other protocol and analysis details are not reported in the registry record, including eligibility criteria beyond the listed infant population and condition, device-use adherence, the statistical model, covariate adjustment, and any missing-data strategy. A detailed statistical analysis plan and any interim analyses are also not reported. These are limits on interpretation of the record; they do not establish that a particular method or problem occurred.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: Sleep Device Testing to Promote Sleep in Infants — NCT05078112.
• Registry record last updated 2024-10-15; status last verified 2024-09.
• Results first posted 2024-10-15.
• 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

NCT05078112 is listed as a completed, single-group device study sponsored by Duke University. The registry lists enrollment of 19 and chronic insomnia as the condition. The intervention is sleep sensor technology used during sleep for 20 days; masking is listed as none and allocation as NA.

The primary outcome is change in mean nighttime awakenings per night, based on parent sleep diaries collected during the 5 days before intervention and the 5 days immediately afterward. Three secondary score changes are listed, and the record reports four outcome measures and one analysis.

The registry record does not report numerical outcome results, uncertainty estimates, missing-data handling, or the primary analysis population. The safety entries report 0 serious adverse events, 0 other adverse events, and 0 deaths for the listed intervention group. The design supports a pre-post description, not a randomized comparison with a control group.