Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses (NCT05419830), a randomized na study. The primary outcome is Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention.

2. Clinical Question

3. Trial Design

The registry describes a randomized, double-masked, parallel-group study and lists its status as completed. The record gives an enrollment of 30 and three arms of 10 participants each. The listed phase is NA. The sponsor is the University of Pittsburgh. The study dates in the record are 2022-06-01 for start and 2023-11-30 for primary completion.

The three assigned approaches separate behavioral insomnia treatment from the timing of antihypertensive medication. Participants in the BBTI arm received behavioral treatment for insomnia from a study nurse and were asked to take their antihypertensive medication within an hour of awakening. The morning-dosing control arm was asked to continue medication within an hour of awakening. The evening-dosing arm was asked to switch a conventional once-daily non-diuretic antihypertensive medication to bedtime.

The primary outcome was measured at baseline and at 6 weeks. The registry describes its calculation as the difference between daytime mean systolic pressure and nighttime mean systolic pressure, expressed as a percentage of the daytime value, over a 48-hour recording period. Four secondary outcomes are named: nocturia frequency, nocturnal polyuria index, global Pittsburgh Sleep Quality Index score, and sleep efficiency. Numerical results are posted for nocturia frequency, nocturnal polyuria index, and global Pittsburgh Sleep Quality Index score. Numerical results for sleep efficiency are not reported in the registry record.

The record labels the study double-masked, but does not identify which participants, clinicians, or assessors were masked, or describe how masking was maintained. Eligibility details, baseline participant characteristics, and the trial's original sample-size justification are not reported in the registry record.

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.

Before assignment: After the telephone screening, eligible participants were scheduled for the first in-person study visit. No study procedures were performed till informed consent was obtained.

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.

Population: Overall, 30 participants were enrolled, 10 randomized to each of the three study arms

6. Primary Endpoint

The registry lists the primary outcome as Change in Mean Sleep Time Systolic Blood Pressure Dip Pre- vs Post-intervention, measured over Baseline and at 6 weeks.

The primary endpoint is change in mean sleep-time systolic blood pressure dip between baseline and 6 weeks. The measure compares daytime mean systolic pressure with nighttime mean systolic pressure and expresses that difference as a percentage of daytime mean pressure. The registry says this was quantified for each participant across a 48-hour recording period at the two assessment times.

This endpoint represents the day-to-night pattern of systolic blood pressure, rather than only a single daytime or nighttime reading. Comparing change across randomized groups can address whether the assigned approaches were associated with different patterns over the follow-up period. The percentage scale relates the day-to-night difference to the daytime value, allowing the endpoint to be expressed relative to daytime pressure.

The registry reports group means and standard deviations for change in this measure. It does not report an interpretation threshold for what size of change would be clinically important, nor does it describe a minimal meaningful difference. The outcome name and measurement description indicate what was measured, but do not by themselves establish whether a particular change is beneficial or important to participants. The registry also does not report an adjusted group effect estimate or confidence interval from its primary ANCOVA analysis. Accordingly, the posted overall p-value can be read as a test result, but the record does not give the adjusted magnitude and precision of the primary between-group effect.

7. Results Posted in the Registry

• BBTI Arm: mean 7.30 versus -0.40 on control; difference 7.70 (95% CI -1.99 to 17.39), standardized effect d = 0.70; z-test p = 0.120.
• PM Antihypertensive Dosing or Chronotherapy Arm: mean 3.90 versus -0.40 on control; difference 4.30 (95% CI -3.60 to 12.20), standardized effect d = 0.48; z-test p = 0.286.

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.

Change in Nocturia Frequency Pre- vs Post-intervention

• 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:
  • BBTI Arm: mean -0.60 versus -0.30 on control; difference -0.30 (95% CI -1.06 to 0.46), standardized effect d = -0.35; z-test p = 0.437.
  • PM Antihypertensive Dosing or Chronotherapy Arm: mean -0.30 versus -0.30 on control; difference 0.00 (95% CI -0.79 to 0.79), standardized effect d = 0.00; z-test p = 1.000.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between BBTI Arm and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PM Antihypertensive Dosing or Chronotherapy Arm and the control. The interval gives the range of effects that remain compatible with the data.

Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention

• 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:
  • BBTI Arm: mean -6.00 versus 0.50 on control; difference -6.50 (95% CI -14.06 to 1.06), standardized effect d = -0.75; z-test p = 0.092.
  • PM Antihypertensive Dosing or Chronotherapy Arm: mean -0.90 versus 0.50 on control; difference -1.40 (95% CI -7.97 to 5.17), standardized effect d = -0.19; z-test p = 0.676.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between BBTI Arm and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PM Antihypertensive Dosing or Chronotherapy Arm and the control. The interval gives the range of effects that remain compatible with the data.

Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention

• 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:
  • BBTI Arm: mean -1.40 versus 0.50 on control; difference -1.90 (95% CI -4.16 to 0.36), standardized effect d = -0.74; z-test p = 0.099.
  • PM Antihypertensive Dosing or Chronotherapy Arm: mean -1.20 versus 0.50 on control; difference -1.70 (95% CI -4.61 to 1.21), standardized effect d = -0.51; z-test p = 0.253.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between BBTI Arm and the control. The interval gives the range of effects that remain compatible with the data.
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between PM Antihypertensive Dosing or Chronotherapy Arm and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover nocturia frequency, nocturnal polyuria index, global Pittsburgh Sleep Quality Index score, and sleep efficiency. Numerical summaries and an ANCOVA p-value are reported for the first three measures, while numerical results for sleep efficiency are not reported in the registry record. Across the outcomes with posted results, the group patterns are not uniform in direction or magnitude. This variability is compatible with the uncertainty in a trial with 10 participants per arm and does not establish a consistent secondary-outcome pattern.

The secondary measures address aspects of nocturia and sleep that are related to the study's broader aims, whereas the primary endpoint is a measure of the day-to-night systolic blood pressure pattern. They offer complementary information but do not substitute for the primary outcome. The overall primary ANCOVA p-value was 0.65; the secondary outcomes do not change that result or establish a different conclusion about the primary endpoint.

Secondary results warrant particular caution because the record does not describe a multiplicity adjustment or identify a prespecified hierarchy among the tests. When several outcomes are examined, the chance of seeing a nominally notable result by chance can increase. The registry's reported ANCOVA p-values for the posted secondary outcomes are 0.66 for nocturia frequency, 0.14 for nocturnal polyuria index, and 0.2 for global sleep quality. These are reported tests, not proof that the measures are unaffected. The pairwise recalculations are unadjusted as well, so they should be treated as exploratory descriptions rather than confirmatory evidence.

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

• Change in Nocturia Frequency Pre- vs Post-intervention
• Change in Nocturnal Polyuira Index (NPi) Pre vs Post-intervention
• Change in Global Pittsburgh Sleep Quality Index (PSQI) Score Pre- vs Post-intervention
• Change in Sleep Efficiency Pre- vs Post-intervention

9. Statistical Interpretation

10. Statistical Methods Explained

The registry reports an analysis of covariance, or ANCOVA, for the primary outcome across the three groups. ANCOVA is a model-based method for comparing group outcomes while accounting for covariates included in the model. When baseline outcome values are included, ANCOVA can estimate differences in follow-up outcomes adjusted for baseline. The registry record does not identify the covariates used, specify the exact model, or report its adjusted group estimates. It is therefore not possible to determine from the record precisely what adjustment was made.

What does the overall test address?

The reported ANCOVA p-value of 0.65 is an overall test across the three randomized groups. An overall test assesses evidence against a model in which the groups have no differences under the analysis assumptions. It does not identify which pair, if any, accounts for a difference, and it does not quantify the size of a group contrast. The record does not report an adjusted confidence interval or estimate alongside this p-value. A p-value is not the probability that the null hypothesis is true, and it does not measure clinical importance.

How are the recalculated contrasts different?

The recalculated mean differences compare each intervention arm with the morning-dosing arm using posted group summaries. They are unadjusted comparisons, rather than the sponsor's ANCOVA results. Their confidence intervals describe uncertainty around these particular summary-statistic comparisons under the recalculation method. The BBTI comparison has an estimate of 7.7 and a 95% confidence interval from -1.995 to 17.39. The evening-dosing comparison has an estimate of 4.3 and a 95% confidence interval from -3.599 to 12.2. These should not be substituted for adjusted results that the registry does not report.

A confidence interval gives a range of effect estimates compatible with the data and the method used, under its assumptions. It conveys precision as well as direction: a wider interval indicates more uncertainty about the size of the contrast. An interval that includes zero does not demonstrate that the groups are equal. It indicates that zero is among the values compatible with the data under that interval procedure.

Why does variability matter?

The primary endpoint is continuous, and the registry reports means and standard deviations. A standard deviation describes variation among observed participant values around a group mean; it is not the uncertainty in the mean itself. With only 10 participants per arm, a few participant values can have considerable influence on a group mean, especially when the outcome varies widely. The primary standard deviations range from 7.9 to 13.5. The BBTI arm has the largest reported standard deviation, and its recalculated contrast has a wide confidence interval.

For continuous outcomes, a mean difference is interpretable in the measurement's units. A standardized effect size, such as the listed d value, expresses the contrast relative to a pooled standard deviation. Standardization can help compare scales, but it does not replace interpretation in the original endpoint units or establish a clinically important effect. The registry does not report a threshold for meaningful change in the primary measure.

What assumptions are relevant?

ANCOVA and summary-statistic comparisons rely on assumptions about the outcome data and model. General considerations include whether the model form is appropriate, whether observations are independent, whether residual variation is adequately represented, and whether any covariate relationships are modeled appropriately. For an ANCOVA, assumptions about how baseline relates to outcome across groups can also matter. The registry record does not provide diagnostics or enough model detail to assess these assumptions.

Random allocation is intended to support fair group comparisons by reducing systematic differences at assignment, but small randomized groups can still differ by chance. The registry does not report baseline characteristics or the analysis population, so readers cannot assess balance or determine whether all randomized participants contributed to the posted outcome summaries. The record also does not describe how missing outcome values were handled. Such details affect how an analysis should be interpreted and reproduced.

Overall, the posted evidence combines an overall sponsor-reported ANCOVA test with descriptive group summaries and unadjusted recalculations. These analyses are informative in different ways, but the missing adjusted estimates, model details, and analysis-population information limit a full statistical assessment.

11. Confidence Intervals and Precision

Precision is limited by the small group sizes and the spread of observed changes. There were 10 participants in each arm. For the unadjusted BBTI-versus-morning contrast, the recalculated mean difference was 7.7 and the 95% confidence interval ran from -1.995 to 17.39. For the evening-dosing-versus-morning contrast, the recalculated mean difference was 4.3 and the 95% confidence interval ran from -3.599 to 12.2. Each interval includes zero and also spans values on both sides of zero.

These intervals indicate that the observed estimates do not pin down a narrow range of plausible differences. They allow uncertainty about both the direction and the magnitude of the contrast. This is not evidence that the approaches are equivalent: the registry does not report an equivalence margin, and the intervals are not equivalence tests. Nor do the intervals show that every value within them is equally likely or clinically meaningful.

The intervals are recalculated from posted summary statistics and are unadjusted. The registry's primary ANCOVA analysis reports p = 0.65, but does not report its adjusted effect estimate or confidence interval. Thus, the recalculated intervals describe a different analysis from the sponsor's primary model. The confidence intervals are also specific to the method used for the recalculation; they do not account for unreported modeling choices or missing-data procedures.

In general, more precise estimates are supported by narrower intervals. Greater participant-level variability and limited sample size tend to reduce precision. The observed standard deviations for the primary endpoint range from 7.9 to 13.5, while each group contains 10 participants. The posted data therefore support cautious description of the observed means, but do not provide a highly precise estimate of the comparative effects.

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 are participants per arm, not total participants or total events. They are illustrations based on the observed effect, not the original trial's design justification. The stated assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each row considers detecting the stated fraction of the observed effect. The original design assumptions and sample-size justification are not reported in the registry record.

The 80% power column gives the illustrative number of participants per arm for a design with an 80% chance of detecting the specified effect under the planning assumptions, if that effect and the assumptions were correct. The 90% power column gives the corresponding planning number for a higher chance of detection. These are prospective design calculations, not a measure of what the completed trial achieved.

Rows that plan for a smaller fraction of the observed effect require more participants per arm. A smaller target effect is harder to distinguish from random variation, all else being equal. The figures should be read as conditional illustrations rather than recommended sample sizes: the observed effect in a small trial may be unstable, and the registry does not establish which effect size would be clinically important. The table's curve represents the planning relationship between the chosen effect fraction and participant numbers. It is not an observed trial result, and this is not observed power.

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 = 7.700; pooled standard deviation σ = 11.060.
2. n = 2 × (1.96 + 0.842)² × 11.060² / 7.700² = 32.4, rounded up to 33 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 <- 7.7                      # observed difference in means
sigma <- 11.0602893271379                     # 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(5419830)
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 = 33 (80% power), 44 (90% power)
 75% of observed effect: n per arm = 58 (80% power), 78 (90% power)
 50% of observed effect: n per arm = 130 (80% power), 174 (90% power)
power.t.test: 33.4 
Simulated power at n = 33 per arm: 0.796 (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. Analyses Reported by the Sponsor

The sponsor-reported primary analysis is an ANCOVA across the three groups, with p = 0.65. The registry record does not give an adjusted effect estimate, confidence interval, covariates, or detailed model specification for this analysis. That reported analysis is the primary account of the sponsor's statistical comparison and takes precedence over recalculated unadjusted contrasts.

The recalculations compare each intervention arm separately with the morning-dosing arm using the posted means and standard deviations. They yield a mean difference of 7.7 for BBTI and 4.3 for evening dosing, with unadjusted p-values of 0.12 and 0.286, respectively. The corresponding confidence intervals include zero. These comparisons are useful for describing the posted summaries, but they are not replacements for the ANCOVA, and they may differ because they do not use the sponsor's model adjustments.

The sponsor's overall p-value does not provide the size or precision of the adjusted group differences. Conversely, the recalculated pairwise estimates do not reproduce the adjusted three-group analysis. The record does not report enough information to reconcile the methods beyond that distinction. Interpretation should keep the sponsor-reported result separate from the unadjusted recalculations rather than treating them as interchangeable tests.

15. Multiplicity, Missing Data and Analysis Populations

The registry lists several outcomes and reports analyses for the primary endpoint and three secondary measures. It does not report whether the investigators adjusted for multiple comparisons, used a prespecified testing hierarchy, or designated any secondary outcomes as confirmatory. Without that information, the posted p-values should not be read as if each were the sole planned test. Testing multiple outcomes can raise the chance of a nominal finding arising by chance, which is why multiplicity procedures or clear prioritization can matter.

The record names sleep efficiency as a secondary outcome, but numerical results for it are not reported in the registry record. The reason the result is absent is not reported. The record also does not describe whether any planned outcomes or analyses were changed, or whether all analyses were prespecified.

Missing-data methods and analysis populations are not reported in the registry record. It is not stated whether the posted summaries include all randomized participants, only participants with observed follow-up data, or another analysis population. The record does not say how missing measurements were handled, whether imputation was used, or whether sensitivity analyses assessed the effect of missingness. These omissions limit assessment of possible bias and make it harder to reproduce the reported analyses.

The record also does not report baseline characteristics, participant flow by analysis, or the statistical model details for ANCOVA. In particular, it does not identify the covariates or describe model diagnostics. These are reporting gaps, not evidence that a particular method was or was not used. They constrain the conclusions that can be drawn from the registry record alone.

16. 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 each arm among 10 participants at risk: 0 in the morning-dosing arm, 0 in the BBTI arm, and 0 in the evening-dosing arm. It also reports 0 other adverse events in each arm among 10 participants at risk, and 0 deaths in each arm. No serious adverse-event terms are listed.

These figures describe what was recorded in the registry for this trial. They do not establish that the approaches are free of risk. With 10 participants per arm, the safety summaries are limited in their ability to characterize uncommon events or differences between groups. The record does not provide additional detail about event definitions, surveillance procedures, duration of safety follow-up, or whether any events were considered related to an intervention. The zero counts should therefore be read as a description of the posted reports, not as a broad safety conclusion.

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

The registry record shows a small randomized comparison of morning antihypertensive dosing, BBTI with morning dosing, and evening antihypertensive dosing. The primary group means differed descriptively, but the sponsor-reported overall ANCOVA p-value was 0.65. The registry does not report an adjusted effect estimate or confidence interval for that analysis. Unadjusted recalculations comparing each intervention arm with the morning-dosing arm have intervals that include zero and are imprecise.

These results do not establish that the groups are equivalent, nor do they establish that one approach is superior. A non-small p-value is not proof of no effect. The study's small groups and the spread of observed values leave considerable uncertainty about the size and direction of possible differences. The registry does not report a clinically important threshold for the primary outcome, so the practical meaning of a particular numerical change cannot be determined from the record alone.

The secondary outcomes provide additional descriptive information about nocturia and sleep, but the number of outcomes and absence of a reported multiplicity approach make them less suitable as stand-alone confirmatory evidence. Numerical results for sleep efficiency are not reported in the registry record. The posted results also do not provide the detailed analysis-population and missing-data information needed to assess how incomplete follow-up may have affected the estimates.

In general, trial results describe evidence in the studied sample and under the analysis methods used; they do not by themselves dictate treatment choices. The record does not establish whether the interventions improve health, how durable any changes are beyond the reported follow-up, or how results apply to people outside the trial population. Eligibility details and baseline characteristics are not reported, further limiting assessment of generalizability.

18. Why This Trial Matters Statistically

This trial is statistically interesting because it places behavioral insomnia treatment and medication timing within one randomized comparison focused on interconnected sleep, nocturia, and blood-pressure measures. Its primary endpoint is not a single blood-pressure reading: it captures the difference between daytime and nighttime mean systolic pressure relative to the daytime value. The endpoint therefore raises a useful design question about how to measure a physiological pattern and compare its change across groups.

The three-arm structure also illustrates why an overall test and pairwise comparisons should be distinguished. The sponsor reports an ANCOVA across the groups, while the recalculated summaries provide unadjusted contrasts against the morning-dosing arm. Those analyses do not estimate exactly the same quantity. Reporting adjusted estimates and confidence intervals alongside an overall test would make the magnitude and precision of the sponsor's comparisons easier to assess.

The small group sizes make the role of uncertainty especially visible. The group means offer a description of observed changes, while the confidence intervals show that the pairwise effects are not precisely determined. This is a useful reminder that a p-value alone does not convey the possible range of effects, and that a result without a small p-value cannot establish equivalence.

The record also illustrates the importance of complete methods reporting. Model details, missing-data procedures, analysis populations, multiplicity handling, and numerical results for one named secondary outcome are not reported. These details help readers distinguish confirmatory analyses from exploratory ones and judge how robust results may be. Statistical interpretation depends not only on the observed values, but also on transparent reporting of how those values were analyzed.

19. 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 small enrollment and 10 participants per arm limit precision and make observed group means sensitive to participant-level variability. The primary standard deviations range from 7.9 to 13.5, and the recalculated confidence intervals are broad enough to include values on both sides of zero. The trial therefore provides limited information about the likely size of comparative effects.

The registry does not provide detailed eligibility criteria or baseline characteristics. Although the study's summary frames the conditions in older adults, the record does not give enough participant information to assess how closely the enrolled sample represents that population or other groups. It also does not report the analysis population, participant flow by outcome, or handling of missing data.

For the primary ANCOVA, the record reports an overall p-value but not an adjusted effect estimate, confidence interval, covariates, or model diagnostics. The unadjusted recalculations cannot fill those gaps because they answer a different statistical question. The record also does not report a clinically important threshold for the primary outcome, an original sample-size justification, or multiplicity procedures. Sleep efficiency is named as a secondary outcome, but its numerical results are not reported in the registry record.

The primary follow-up is described at 6 weeks, and longer-term outcomes are not reported. The registry does not identify which parties were masked or explain how masking was maintained. These reporting limitations constrain evaluation of precision, possible bias, and generalizability; they do not, on their own, establish that any specific bias occurred.

20. Related Tutorials

21. Related Statistical Calculators

22. Sources

• ClinicalTrials.gov: Sleep, Hypertension, and Nocturia: a Multicomponent Approach for Comorbid Illnesses — NCT05419830.
• Registry record last updated 2024-12-17; status last verified 2024-11.
• Results first posted 2024-12-17.
• 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.

23. Record Summary

This completed, randomized, double-masked, parallel-group study enrolled 30 participants across morning antihypertensive dosing, BBTI with morning dosing, and evening antihypertensive dosing arms. Each arm had 10 participants. The primary endpoint was change in mean sleep-time systolic blood pressure dip from baseline to 6 weeks.

The registry reports an overall primary ANCOVA p-value of 0.65, without an adjusted effect estimate or confidence interval. Unadjusted pairwise recalculations have confidence intervals that include zero. Secondary numerical results are reported for nocturia frequency, nocturnal polyuria index, and global sleep quality; sleep-efficiency results are not reported in the registry record. The small groups, imprecise contrasts, and missing analysis details call for cautious interpretation.