Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment (NCT04364191), a randomized na study. The primary outcome is Sleep Latency.

2. Clinical Question

The trial addresses a practical research question: whether a brief, non-pharmacological, multicomponent program can be evaluated against sleep education in a group described as older adults with both mild cognitive impairment and insomnia. The intervention combines education, structured daytime activity and a nighttime relaxation component, so the comparison concerns the package rather than any one component in isolation.

The registry describes the study as a randomized pilot. Its purpose, as stated in the study summary, is to inform future larger trials. The posted primary outcome concerns sleep latency immediately after the intervention, with the assessment timeframe given as 4-5weeks after the intervention began. The result is a comparison of group means at that assessment; it does not by itself establish what would happen in a different population, with a different program, or over a longer follow-up. Further eligibility criteria, the method used to confirm insomnia, and details about the participants' cognitive status beyond the condition label are not reported in the registry record.

3. Trial Design

The registry identifies this as a randomized, triple-masked, parallel-group pilot study. Participants were allocated to either the Multicomponent Behavioral Sleep Intervention for Insomnia or an active control. The registry lists enrollment as 27 and status as completed. It records a start date of 2021-05-13 and primary completion date of 2022-08-30. The study is listed as phase NA and sponsored by the University of Pennsylvania.

The intervention is described as brief, tablet-based and personalized, with a 4 week duration. Its stated components include sleep hygiene education, meaningful-activity modules for physical activity, cognitive activity and social engagement, and Assisted Relaxation Therapy at night. The control also involved a tablet and watch, and its sleep-hygiene educational material is described as an active control. The registry says the control group could not access the meaningful-activity modules or ART software. More detailed descriptions of how the program was personalized or delivered are not reported in the registry record.

The primary outcome was sleep latency in minutes, assessed by sleep diary immediately post-intervention; the timeframe is also specified as 4-5weeks after the intervention began. The posted primary group results include 12 observations in the intervention arm and 13 in the control arm. This is not a statement about why those result counts differ from the enrollment figure; the registry record does not explain the relationship between enrollment and the numbers contributing to each outcome.

The masking label is triple, but the identities of the masked groups and the practical masking procedures are not reported in the registry record. The original sample-size justification, allocation concealment method, detailed randomization procedure, analysis population, and prespecified statistical plan are also not reported in the registry record. These omissions limit how fully the trial's conduct and analysis decisions can be reconstructed from the registry entry alone.

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 Sleep Latency, measured over immediately post-intervention (4-5weeks after the start of the intervention).

Sleep latency is the time it takes a person to fall asleep, beginning from the first intention to sleep. In this trial it was measured in minutes using a sleep diary, with the primary assessment scheduled immediately post-intervention; the registry specifies the timeframe as 4-5weeks after the intervention began.

This measure is used to represent one aspect of sleep initiation. It captures how long participants report taking to fall asleep, rather than sleep duration, awakenings during the night, or overall sleep quality. A group mean offers a compact description of the typical recorded latency, while the standard deviation describes the spread of individual observations around that mean. The mean difference compares the intervention-arm mean with the control-arm mean; a negative difference in the posted comparison indicates a lower mean latency in the intervention arm.

Diary-based measurement is consistent with the behavioral focus of the intervention and gives a participant-reported estimate tied to the stated sleep intention. As a general measurement consideration, a diary outcome can reflect both the underlying experience and how consistently or accurately it is recorded. The registry does not describe diary instructions, adherence checks, or whether diary data were supplemented by an objective measure for the primary endpoint. The endpoint therefore speaks specifically to the posted diary-based measure at the immediate post-intervention assessment, not to every dimension of sleep or to longer-term change.

7. Results Posted in the Registry

• Intervention Arm: mean 28.51 versus 47.06 on control; difference -18.55 (95% CI -44.34 to 7.24), standardized effect d = -0.56; z-test p = 0.159.

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.

Wake After Sleep Onset (WASO)

• 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:
  • Intervention Arm: mean 29.57 versus 37.25 on control; difference -7.68 (95% CI -33.67 to 18.31), standardized effect d = -0.23; z-test p = 0.562.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention Arm and the control. The interval gives the range of effects that remain compatible with the data.

Total Sleep Time (TST)

• 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:
  • Intervention Arm: mean 368.78 versus 361.43 on control; difference 7.35 (95% CI -56.51 to 71.21), standardized effect d = 0.09; z-test p = 0.822.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention Arm and the control. The interval gives the range of effects that remain compatible with the data.

Sleep Efficiency (SE)

• 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:
  • Intervention Arm: mean 77.00 versus 68.00 on control; difference 9.00 (95% CI -1.20 to 19.20), standardized effect d = 0.69; z-test p = 0.084.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Intervention Arm and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover several aspects of sleep: wake after sleep onset, total sleep time, sleep efficiency and self-reported insomnia symptoms. The outcomes listed include repeated entries for the named measures, while the registry indicates 10 secondary results posted. The available summary comparisons include group means, standard deviations and unadjusted comparisons for wake after sleep onset, total sleep time and sleep efficiency. The registry record does not include reported analyses for these secondary outcomes.

Across the available continuous comparisons, the estimated differences do not all point in the same direction. The broad pattern is therefore not a uniform shift across every sleep measure. This context can help describe the primary result: sleep latency is one dimension of sleep, and the other outcomes assess related but distinct dimensions. Agreement or disagreement across measures can be informative, but it does not make one result a substitute for another. Nor does a pattern among several outcomes establish a mechanism or demonstrate a durable effect.

Each secondary estimate has its own uncertainty, and the posted results are unadjusted. When multiple outcomes are examined, the chance of at least one apparently notable finding can increase even if there is no underlying effect; this is a general statistical issue. Without a reported multiplicity strategy, secondary p-values should be treated as exploratory and interpreted alongside estimates and intervals rather than as independent confirmatory tests. The registry does not report a hierarchy of secondary outcomes or identify which, if any, were designated as especially important.

The secondary results can contribute to planning and to a broader description of the pilot, but they carry less confirmatory weight than a prespecified primary comparison. The record does not report the planned analysis strategy needed to assess whether the number and selection of secondary measures were controlled in advance. No inference should be drawn from unreported secondary results, and the available secondary pattern should not be used to overrule the uncertainty in the primary sleep-latency result.

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

• Wake After Sleep Onset (WASO)
• Wake After Sleep Onset (WASO)
• Total Sleep Time (TST)
• Total Sleep Time (TST)
• Sleep Efficiency (SE)
• Sleep Efficiency (SE)
• Self- Reported Insomnia Symptoms
• Self- Reported Insomnia Symptoms

9. Statistical Interpretation

10. Statistical Methods Explained

What does the mean difference represent?

For a continuous outcome, a mean difference expresses the contrast between the two arm means in the outcome's original units. Here the outcome is sleep latency in minutes, and the stated comparison is intervention minus control. The posted means are 28.51 minutes for the intervention arm and 47.06 minutes for the control arm; the listed mean difference is -18.55 minutes. A negative value means the intervention-arm mean is lower on this measure. It does not mean every participant in that arm had a lower latency, because a group mean does not describe each person's result.

The standard deviations describe variation among observed values within each arm. They are not standard errors and do not directly quantify uncertainty in the difference between the means. In the primary results, the standard deviation is 31.18 minutes for the intervention arm and 34.61 minutes for the control arm. The broad individual variation relative to the point estimate is one reason the estimated group contrast is imprecise. This is a general interpretation of means and standard deviations, not a claim about individual responses.

What does the p-value say?

The unadjusted p-value for the posted primary comparison is 0.159. As a general statistical concept, a p-value describes how unusual data at least as incompatible with a specified null model would be if that model and its assumptions held. It is not the probability that the null hypothesis is true, nor the probability that the result occurred by chance. A p-value also does not communicate the range of effect sizes consistent with the data, so it should be interpreted alongside the estimated difference and confidence interval.

The registry record does not report the exact inferential test or model used for the primary comparison. It also does not report adjustment for baseline measurements or other covariates. The posted comparison can be described as unadjusted, but a more detailed reconstruction of the sponsor's analysis is not possible from the information in the registry record.

Why does the confidence interval matter?

A confidence interval is a range calculated by a statistical procedure that, under its assumptions and repeated use, would contain the target parameter at the stated confidence level at the corresponding rate. For this primary contrast, the 95% confidence interval runs from -44.34 to 7.241 minutes. A general interpretation is that the data and method leave considerable uncertainty about the true mean difference. The interval includes zero, so it is consistent with no mean difference, but it also contains negative and positive values. It is not a range containing a known proportion of individual participants' sleep latencies.

Confidence intervals depend on the analysis method and assumptions. The registry does not state the method used to construct the primary interval, and no adjusted model is listed. The interval should therefore be read as the posted uncertainty summary, not as evidence that all sources of uncertainty have been addressed.

What do the planning calculations represent?

The sample-size illustrations use the observed effect as a starting point and consider planning for the full observed effect, 75% of that effect, and 50% of that effect. As a general concept, a power calculation asks how often a specified design would detect an effect of a specified size under its assumptions. These calculations are prospective planning illustrations, not a measure of the probability that the completed pilot detected an effect. The assumptions listed for them are a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect to detect equal to the stated fraction of the observed effect.

The original design assumptions for this trial are not reported in the registry record. The planning illustrations therefore should not be treated as evidence that the trial was designed around the same effect or assumptions. The calculated participant counts are per arm for these continuous outcomes. Smaller target effects require more participants under the stated planning framework, because a smaller contrast is harder to distinguish from variability.

What is not available about the analysis?

The registry lists no reported analyses. It does not report the primary analysis population, handling of missing outcomes, use of baseline adjustment, model diagnostics, or procedures for multiple outcome comparisons. These details matter because they define precisely which observations and statistical procedures contribute to an estimate. As a general matter, missing observations can affect precision and can also affect the interpretation of a group contrast if their absence is related to outcome values or trial assignment. Without a reported missing-data approach, no such mechanism or correction should be assumed.

The randomized parallel design supports a comparison between assigned groups, but the registry information alone does not establish the extent to which the posted results follow an intention-to-treat approach or another analysis population. Nor does the triple-masking label reveal which participants or study personnel were masked. The posted results can be interpreted descriptively and with their stated uncertainty, while the unreported analysis details remain important limitations on methodological appraisal.

11. Confidence Intervals and Precision

The primary mean difference is -18.55 minutes, and its 95% confidence interval extends from -44.34 to 7.241 minutes. This interval is wide relative to the point estimate and crosses zero. It therefore leaves uncertainty both about the direction of the underlying mean contrast and about its magnitude. Values toward the negative end would correspond to a substantially lower mean sleep latency in the intervention arm; values on the positive side would correspond to a higher mean in that arm. The estimate is not precise enough to rule out either direction.

A confidence interval is not a guarantee that the true effect lies inside its particular endpoints, and it is not a description of the spread of individual sleep-diary values. It quantifies uncertainty in an estimate under the methods and assumptions used to produce it. The registry does not identify the exact method used for this interval, so readers cannot assess all of those assumptions from the record.

The number of observations attached to the posted primary outcome is 12 in the intervention arm and 13 in the control arm. With limited outcome information and substantial standard deviations in both arms, the estimate has considerable sampling uncertainty. The unadjusted p-value of 0.159 is consistent with this imprecision but is not a substitute for interpreting the interval itself. Neither the interval nor the p-value establishes that there is no effect; rather, they show that the posted primary result does not tightly determine the size or direction of the mean difference.

Precision is also specific to the assessment and measure. These results concern sleep latency from diary records immediately post-intervention, within the stated 4-5weeks timeframe. They do not provide precision information for later follow-up or for other aspects of sleep. The registry record does not report confidence intervals for the arm-specific means or a separate analysis that would clarify how adjustments might change the primary contrast.

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 for the continuous outcomes are participants per arm, not total participants across both arms and not total events. The stated calculation assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, a normal approximation, and a target effect equal to the stated fraction of the observed effect. The table considers planning for 100%, 75% and 50% of the observed effect.

The 80% power column gives the planned participants per arm for a design that would have an 80% probability of detecting the specified effect under those assumptions. The 90% power column gives the corresponding participants per arm for a design with a 90% probability under the same assumptions. In general, greater planned power requires more participants. For example, for the primary sleep-latency outcome, the listed figures are 50 participants per arm for 80% power and 67 for 90% power when planning for the full observed effect; for 75% of the observed effect, they are 89 and 119. The values at 50% of the observed effect are 199 and 267.

Smaller effects are harder to distinguish from random variation, so the planning figures rise as the target fraction of the observed effect falls. These are illustrative calculations based on the observed effect, not the trial's own original design assumptions; those original assumptions are not reported in the registry record. This is not observed power: it does not describe the probability that the completed trial's result is true or that the trial succeeded. It is a planning aid for considering future studies under the stated assumptions.

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 = -18.550; pooled standard deviation σ = 33.014.
2. n = 2 × (1.96 + 0.842)² × 33.014² / -18.550² = 49.7, rounded up to 50 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 <- -18.55                      # observed difference in means
sigma <- 33.0140560315175                     # 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(4364191)
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 = 50 (80% power), 67 (90% power)
 75% of observed effect: n per arm = 89 (80% power), 119 (90% power)
 50% of observed effect: n per arm = 199 (80% power), 267 (90% power)
power.t.test: 50.7 
Simulated power at n = 50 per arm: 0.792 (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 a primary outcome and multiple secondary sleep outcomes, but it does not report a plan for controlling multiplicity. Multiplicity arises when several hypotheses are assessed: even if each individual test uses a conventional threshold, considering many results can increase the chance of at least one apparently unusual finding. As a general statistical principle, prespecifying a hierarchy or adjustment can help distinguish confirmatory tests from exploratory ones. The registry record does not state whether such a hierarchy or adjustment was used.

The posted secondary comparisons are unadjusted, and no reported analyses are listed for the secondary outcomes. Their p-values, where posted, should therefore be read as descriptive evidence rather than as a set of multiplicity-controlled confirmatory tests. The registry does not identify which secondary outcomes were prespecified, whether any outcome was added or removed, or whether the analysis plan changed.

Missing-data procedures are not reported in the registry record. Outcome counts differ across the primary and adverse-event reporting, but the record does not explain why, identify the status of observations without posted outcome values, or state whether missingness was related to treatment assignment or outcome. It would be inappropriate to infer attrition reasons or assume a particular imputation or complete-case method. As a general matter, missing data can reduce precision and may bias a comparison if the probability of missingness is connected to outcomes or group assignment.

The record also does not name the analysis population, such as whether the primary result used all randomized participants or another defined group. It does not report adherence-based exclusions or an intention-to-treat analysis. The posted estimates should accordingly be interpreted as the reported group summaries, without assigning them to an analysis population that the registry does not specify.

These omissions do not change the numerical results, but they limit evaluation of how robustly the analysis addressed multiple comparisons and incomplete observations. A fuller report of the prespecified analysis plan, participant flow, outcome completeness and missing-data handling would be needed to resolve these questions.

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.

The adverse-event results list 13 participants at risk in the intervention arm and 14 in the control arm. The record reports 0 serious adverse events and 0 other adverse events in each arm, with 0 deaths in each arm. These are counts in the registry's adverse-event reporting; they do not indicate that the groups had identical risk, or that no unrecorded event occurred.

Zero reported events in a small pilot should be read as an absence of events recorded in these results, not as proof that an intervention has no safety risks. The numbers at risk for adverse-event reporting differ from the primary outcome counts, and the registry does not explain the relationship between these reporting populations. It also does not state the adverse-event observation period, event-collection procedures, or whether events were assessed for causal relation to an intervention. No serious-event terms are listed.

These figures give a limited description of reported events during the study. They do not support broad conclusions about safety in other groups, with longer observation, or under different delivery conditions. The registry record does not report further detail that would allow a more complete assessment.

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

The posted primary result is an estimate of the difference in mean diary-recorded sleep latency between the randomized intervention and active-control groups at the immediate post-intervention assessment. The intervention-arm mean was lower, and the point estimate for the intervention-minus-control difference was -18.55 minutes. However, the confidence interval extends from -44.34 to 7.241 minutes and includes zero, while the unadjusted p-value is 0.159. The result is therefore uncertain about both the direction and size of the underlying mean difference.

This does not establish that the intervention improves sleep, and it does not establish that the intervention has no effect. It describes what was observed in this pilot and how imprecisely the primary contrast was estimated. The confidence interval includes results favoring either group, and a p-value is not a probability that a treatment claim is true or false. The study's stated pilot purpose is consistent with treating these data as preliminary evidence for planning and evaluation rather than as a definitive answer.

The comparator matters. The control was active and included sleep-hygiene education, so the result concerns the multicomponent program relative to that educational control. It is not a comparison with no intervention. Because the program contains several components, the estimate cannot determine which component may have contributed to the observed group means.

The endpoint is also narrow: diary-based sleep latency at one immediate post-intervention assessment. The result does not establish effects on every sleep measure, longer-term outcomes, or health-related quality of life. Although the registry lists secondary sleep outcomes, those comparisons are exploratory in the absence of a reported multiplicity plan and full analysis strategy. The record does not report enough about missing data or analysis populations to extend the interpretation beyond the posted summaries.

These results should be understood as evidence from a randomized pilot in the specified population and setting, not as a prediction for every older adult with insomnia or mild cognitive impairment. They do not provide medical advice or a basis for individual treatment decisions. Further evidence would be needed to clarify the size, precision, persistence and generalizability of any effect.

17. Why This Trial Matters Statistically

This trial is statistically important as an example of the role a randomized pilot can play before a larger evaluation. Its stated objective is to test a brief, multicomponent behavioral intervention against an active sleep-education control and inform future trials. In that setting, estimation and uncertainty matter as much as a binary interpretation of a test result. The primary contrast supplies a preliminary estimate, while its wide confidence interval makes clear that the estimate is not yet precise.

The study also illustrates why a comparator's content matters when interpreting an effect. Sleep education was present in the control arm, and the intervention added structured meaningful activity and nighttime relaxation components. The contrast therefore addresses the incremental difference between these program packages. It cannot identify the effect of each element separately, and it does not estimate a contrast against no care or no education.

The posted outcome is diary-based sleep latency, whereas the registry includes other sleep dimensions as secondary measures. That distinction is useful in trial design: a clear primary endpoint focuses the main question, while secondary measures can help describe whether results appear consistent across related domains. At the same time, multiple unadjusted comparisons call for restraint, particularly when the analysis plan and multiplicity strategy are not reported.

The planning illustrations further show how the observed estimate can be translated into possible future-study requirements under explicit assumptions. Their values change when the target effect is smaller or the desired power is higher. These are planning exercises rather than evidence of the trial's original design or of observed power. Together, the result, its uncertainty, and the planning framework are most useful as inputs to a better specified future study—not as a definitive treatment conclusion.

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 features of this particular registry record constrain interpretation. First, the study is a pilot with enrollment listed as 27, while the posted primary summaries list 12 observations in the intervention arm and 13 in the control arm. The record does not explain the relation between enrollment and these outcome counts, provide participant flow, or state why some enrolled participants may not appear in the primary summaries. No reason for the count pattern should be inferred.

Second, the primary endpoint is a diary-based measure at an immediate post-intervention time point. The registry does not report the diary protocol, compliance information, objective confirmation, or longer-term follow-up for this endpoint. The results therefore address only the defined post-intervention measurement, not persistence or other aspects of sleep.

Third, the intervention is multicomponent. The comparison cannot separate sleep hygiene, daytime activity, social engagement, cognitive activity or Assisted Relaxation Therapy as individual contributors. The control is active, which helps define the contrast but also means the findings cannot be interpreted as intervention versus no support.

Fourth, methodological details needed to appraise the estimates are not reported in the registry record: the original sample-size justification, detailed randomization and concealment procedures, identities of masked groups, analysis population, missing-data approach, and primary statistical model. The registry also does not report a multiplicity plan for the secondary outcomes. These omissions limit assessment of potential analytic choices and the strength of the secondary evidence.

Finally, the primary confidence interval is wide, and the available outcome counts are limited. The pilot's estimates may be unstable and should not be generalized beyond the registered population and assessment without further evidence. The registry record does not report enough information to assess representativeness or broader applicability.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Multicomponent Behavioral Sleep Intervention for Insomnia in Older Adults With Mild Cognitive Impairment — NCT04364191.
• Registry record last updated 2024-05-29; status last verified 2024-05.
• Results first posted 2024-05-29.
• 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 completed randomized, triple-masked, parallel pilot study of a tablet-based multicomponent behavioral sleep intervention compared with active sleep education in older adults with mild cognitive impairment and insomnia. Enrollment is listed as 27. The primary outcome is sleep latency in minutes measured by sleep diary immediately post-intervention, with the timeframe specified as 4-5weeks after the intervention began.

Mean sleep latency was 28.51 minutes in the intervention arm and 47.06 minutes in the control arm. The posted mean difference was -18.55 minutes, with a 95% confidence interval from -44.34 to 7.241 minutes and an unadjusted p-value of 0.159. The interval includes no difference and spans both negative and positive values, leaving substantial uncertainty about the underlying contrast.

The registry includes secondary sleep outcomes and reports no serious or other adverse events or deaths in either arm. Key details about the original design assumptions, analysis population, missing-data handling, multiplicity and full statistical plan are not reported in the registry record. Overall, the posted results are best read as preliminary estimates from a pilot rather than as a definitive conclusion.