Treatment of Sleep-disordered Breathing in Patients With SCI: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Treatment of Sleep-disordered Breathing in Patients With SCI (NCT02830074), a randomized na study. The primary outcome is PAP Adherence.

2. Clinical Question

The registry summary anticipated higher PAP use and improvements in sleep quality, general functioning, respiratory functioning, and quality of life in the program group compared with the control program. Those statements describe the investigators’ expectations, not results. The posted primary outcome is narrower: it counts nights of PAP use meeting the stated duration threshold during the first 90 days, measured by remote monitoring. It does not directly measure sleep quality or overall functioning.

The primary comparison is between randomized groups, rather than a comparison of participants’ outcomes with an external benchmark. The posted group means are 22.03 nights for The BEST Program and 18.54 nights for the sleep education and standard-treatment group. The recalculated unadjusted mean difference is 3.49 nights, with a 95% confidence interval from -8.712 to 15.69. The interval includes both negative and positive differences, so the posted summary statistics do not determine a precise direction or size of the group difference.

3. Trial Design

The registry record describes a randomized, double-masked, parallel-group trial. Participants were assigned to The BEST Program or to sleep education and standard sleep-disordered breathing treatment. The registry lists enrollment of 73. The posted primary outcome counts nights with at least 4 hours of PAP use during the first 90 days, using remote monitoring. The outcome is expressed as a mean number of nights, with a stated possible range of 0 to 90 days.

The BEST Program was a combined sleep and PAP-adherence program involving best-practices PAP, patient education, and ongoing support and training. The comparison program consisted of non-directive sleep education plus standard sleep-disordered breathing treatment. This is therefore a comparison of two programs, not a comparison of PAP treatment with no treatment: standard treatment is part of the comparison arm description.

The registry lists the study as completed and records a start date of 2017-05-01 and primary completion date of 2019-09-30. The phase is recorded as not applicable. The posted primary-outcome summaries include 32 participants in The BEST Program group and 31 in the comparison group. The respiratory-function summaries include 30 participants per group; the depressive-symptom and fatigue summaries include 31 per group. These varying numbers indicate that the count contributing to a particular posted outcome is not identical across all outcomes. Reasons for those differences and participant flow are not reported in the registry record.

The registry summary describes anticipated changes from baseline to 6 months follow-up, while the posted primary outcome timeframe is 90 days. The outcome-specific timeframe is the relevant one for interpreting each posted statistic; the relationship between the summary’s anticipated follow-up and the specific posted outcome timing is not explained in the registry record. Further details of allocation procedures, masking procedures, and the original analysis plan 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.

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 PAP Adherence, measured over 90 days.

The primary endpoint is PAP adherence, measured as the number of nights during the first 90 days on which positive airway pressure was used for at least 4 hours. The registry says use was measured by remote monitoring. Scores range from 0 to 90 days, and higher scores indicate more nights meeting the stated use threshold.

This endpoint turns device use into a count over a defined period. It is directly relevant to whether participants used PAP regularly, but it is not a measure of the quality of sleep, respiratory physiology, or broader functioning. A night counts if it meets the threshold; the measure does not describe how much longer than 4 hours the device was used on qualifying nights.

In general, a mean is useful for describing the average outcome across participants, while the standard deviation describes how spread out individual outcomes are around that average. The posted means are 22.03 nights in The BEST Program group and 18.54 nights in the sleep education and standard-treatment group. Their standard deviations are 24.74 and 24.67, respectively. The substantial spread relative to the group averages is important context: participants’ adherence values varied, and the mean difference alone does not describe that variation.

The registry describes the primary endpoint and its scale, but the rationale for selecting this endpoint, the threshold, or the 90-day period is not reported in the registry record.

7. Results Posted in the Registry

• The BEST Program: mean 22.03 versus 18.54 on control; difference 3.49 (95% CI -8.71 to 15.69), standardized effect d = 0.14; z-test p = 0.575.

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.

Respiratory Function: Spirometry and Respiratory Muscle Force

• 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:
  • The BEST Program: mean 3.38 versus 3.20 on control; difference 0.18 (95% CI -0.33 to 0.69), standardized effect d = 0.18; z-test p = 0.488.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between The BEST Program and the control. The interval gives the range of effects that remain compatible with the data.

Depressive Symptom Severity

• 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:
  • The BEST Program: mean 5.03 versus 8.38 on control; difference -3.35 (95% CI -6.42 to -0.28), standardized effect d = -0.54; z-test p = 0.033.
• Interpretation:
  • The 95% confidence interval excludes no difference, so the mean is statistically lower for The BEST Program than for the control. This is an unadjusted, secondary comparison, so it is suggestive rather than confirmatory.

Fatigue Symptoms

• 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:
  • The BEST Program: mean 9.61 versus 12.12 on control; difference -2.51 (95% CI -6.94 to 1.92), standardized effect d = -0.28; z-test p = 0.267.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between The BEST Program and the control. The interval gives the range of effects that remain compatible with the data.

The registry lists six secondary outcomes, spanning quality of life, respiratory function, functional status, depressive symptoms, fatigue, and sleepiness. Numerical group summaries are posted for respiratory function, depressive symptom severity, and fatigue symptoms. Numerical results for the other listed outcomes are not reported in the registry record. The available secondary results therefore give only a partial view of the broader outcome set described in the record.

Across the three outcomes with posted numerical summaries, the recalculated estimates do not all point in the same direction or carry the same degree of uncertainty. Two confidence intervals include zero, while the depressive-symptom interval does not. These observations should be interpreted in relation to the primary result, which is itself imprecise and does not establish a clear group difference in PAP adherence. Secondary endpoints can help characterize whether outcomes beyond adherence appear to move in a consistent way, but they do not replace the primary comparison.

The registry gives no direction-of-benefit description for every secondary scale. In particular, a numerical increase or decrease cannot automatically be labeled favorable without knowing how the scale is scored. The posted names and units alone do not establish what size of change would matter to participants.

Unadjusted secondary findings carry less weight when several outcomes are examined. In general, multiple testing increases the chance of an apparently unusual result even if there is no true effect on any outcome. The registry record does not report a multiplicity strategy, a hierarchy among secondary endpoints, or inferential analyses for them. For that reason, one unadjusted result should be treated as exploratory context rather than as a stand-alone conclusion. The limited number of outcomes with numerical summaries also means the overall secondary pattern cannot be fully assessed from the registry record.

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

• Quality of Life Was Measured by WHO-QOL BREF Questionnaire
• Respiratory Function: Spirometry and Respiratory Muscle Force
• Functional Status Was Measured by CHART Questionnaire.
• Depressive Symptom Severity
• Fatigue Symptoms
• Epworth Sleepiness Scale

9. Statistical Interpretation

10. Statistical Methods Explained

The numerical comparisons below are simple, unadjusted recalculations from the posted group summaries. The registry record does not list reported analyses for the outcomes discussed. These calculations should therefore be read as descriptive statistical comparisons of the posted means and standard deviations, rather than as a substitute for a trial analysis that may have used additional information or adjustments. The registry record does not report the original statistical analysis plan.

What does a mean difference describe?

For a continuous outcome, a mean difference subtracts the comparison-group mean from the intervention-group mean. A positive value means the intervention-group mean is higher on the numerical scale; a negative value means it is lower. Whether higher or lower is favorable depends on the outcome’s scoring direction. For PAP adherence, higher values are explicitly described as better. The primary mean difference is 3.49 nights, calculated from posted means of 22.03 and 18.54. This is an unadjusted group contrast, not a change-from-baseline estimate.

A mean difference summarizes average separation but does not describe every participant’s response. Standard deviations provide context about the spread of individual observations. The primary outcome standard deviations are 24.74 and 24.67, in comparison with group means of 22.03 and 18.54. With substantial spread, individual values can differ widely even when the group means are close. The posted summaries do not show the shape of the distributions or whether particular values were concentrated near the endpoints of the 0 to 90 range.

What does a confidence interval add?

A confidence interval communicates uncertainty around an estimated group difference. In general, a wider interval indicates less precision, while a narrower interval indicates greater precision. The primary 95% confidence interval runs from -8.712 to 15.69. It includes zero, the value corresponding to no difference between group means, and also includes values on either side. The interval is therefore not a precise estimate of the direction of the difference. A confidence interval is not a list of observed individual outcomes, and its width does not establish whether a difference is important to patients.

How should an unadjusted p-value be read?

A p-value evaluates how compatible the observed estimate is with a specified no-difference model under the assumptions of the calculation. The primary unadjusted p-value is 0.575. It does not measure the probability that the program is effective, the probability that the null model is true, or the clinical importance of the estimate. A p-value also does not replace the estimate and confidence interval: the interval provides a range of values compatible with the calculation, while the estimate indicates the observed direction and scale.

The unadjusted p-values for the three numerically posted secondary comparisons are 0.488 for respiratory function, 0.033 for depressive symptom severity, and 0.267 for fatigue symptoms. Since the registry does not list analyses for these outcomes, these p-values are recalculated from summary statistics. They do not account for the fact that multiple outcomes were assessed, and the registry record does not report a multiplicity adjustment. In general, testing several outcomes increases the chance that at least one result appears notable by chance, so isolated secondary findings warrant caution.

Why can over-dispersion matter?

In general, over-dispersion means that observations vary more than a statistical model expects. That can make standard errors too small and confidence intervals too narrow if the model does not accommodate the extra variation. The posted data describe continuous outcomes with means and standard deviations; they do not identify a particular over-dispersion model or report a model-based adjustment. For the primary endpoint, the standard deviations are large relative to the means. This is a reason to attend to the observed spread and the precision of the estimate, not grounds to infer that a specific alternative model was used or required.

The outcome is bounded from 0 to 90, while the simple recalculation treats the posted group summaries as continuous measurements. The registry does not report whether the original analysis accounted for this bounded scale, the distribution of the outcome, or baseline adherence. No assumptions about those choices can be recovered from the posted summaries alone.

What does randomization contribute?

In general, random assignment is intended to make comparison groups similar on average at the time of assignment, including for factors that may not be measured. It supports an interpretation of the group contrast as a comparison of assigned programs when allocation is implemented as intended and follow-up and analysis preserve that comparison. The registry identifies the study as randomized, but does not report enough detail to assess allocation concealment, adherence to assignment, or the analysis population. The posted group summaries alone cannot establish how those features were handled.

The primary recalculation is unadjusted and based on outcome summaries. The registry record does not report whether the sponsor used covariate adjustment, a different estimand, or other analysis choices. The discrepancy flag is false, so there is no stated disagreement between the recalculation and a sponsor analysis in the available record. Still, the unadjusted values should be distinguished from any analysis that might have been conducted but is not reported in the registry record.

11. Confidence Intervals and Precision

Precision is about how narrowly the data locate a group difference. The primary estimate is 3.49 nights, and its 95% confidence interval extends from -8.712 to 15.69. Because the interval includes zero and spans both negative and positive values, the estimate does not precisely establish whether the average number of qualifying nights was higher or lower in The BEST Program group. The interval also allows differences larger than the point estimate in either direction. It should be read alongside the reported group means and standard deviations, not as a statement about the range of individual participants’ outcomes.

The interval width reflects both the observed variability and the number of participants contributing to the comparison. The posted primary summaries include 32 participants in The BEST Program group and 31 in the comparison group, with standard deviations of 24.74 and 24.67. The spread is large relative to the difference between the means, which is consistent with limited precision. The interval does not say that every value within it is equally plausible, and it does not give the probability that the true difference falls inside it.

For the secondary outcomes with numerical summaries, the respiratory-function interval is -0.329 to 0.689, and the fatigue interval is -6.944 to 1.924; each includes zero. The depressive-symptom interval is -6.422 to -0.278 and does not include zero in this unadjusted recalculation. These intervals are outcome-specific and measured in different units, so their widths cannot be compared directly to decide which endpoint is more precise. The registry record does not provide a clinically important difference for the primary or secondary outcomes, nor does it report a prespecified precision target. As a result, statistical uncertainty can be described, but the range cannot be classified as clinically negligible or important based on the registry record alone.

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 sample-size figures are planning illustrations based on the observed effect, not the trial’s original design assumptions. For these continuous outcomes, the listed figures are participants per arm, not total participants. The calculations use a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. The effect to detect is the stated fraction of the observed effect. The original trial’s sample-size justification and assumptions are not reported in the registry record. These are planning illustrations, not observed power.

The 80% power column gives the estimated participants per arm for a future study to have an 80% chance of detecting the specified effect under those assumptions, if that effect is the true one. The 90% power column gives the corresponding estimate for a 90% chance. Power is a design property under assumptions; it is not the probability that a result is true or the probability that this trial’s finding is reproducible.

For the primary outcome, the planning values are 787 participants per arm for 80% power and 1,054 for 90% power when planning for 100% of the observed effect. For 75% of the observed effect, the values are 1,399 and 1,873; for 50%, they are 3,147 and 4,213. The same pattern appears in the secondary planning values: smaller target effects require more participants per arm to maintain the stated power, all else held to the listed assumptions. The calculation uses the observed effect as its starting point, so its results are sensitive to that estimate and should not be treated as a guaranteed design recommendation.

The sample-size curve visualizes how the planning requirement changes with the target effect under the same assumptions. It does not show observed enrollment, participant outcomes, or the probability that the observed effect is real. The registry does not report the assumptions used to design the completed trial, so these illustrations should not be read as a reconstruction of its original sample-size calculation.

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 = 3.490; pooled standard deviation σ = 24.706.
2. n = 2 × (1.96 + 0.842)² × 24.706² / 3.490² = 786.6, rounded up to 787 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 <- 3.49                      # observed difference in means
sigma <- 24.705598555793                     # 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(2830074)
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 = 787 (80% power), 1,054 (90% power)
 75% of observed effect: n per arm = 1,399 (80% power), 1,873 (90% power)
 50% of observed effect: n per arm = 3,147 (80% power), 4,213 (90% power)
power.t.test: 787.6 
Simulated power at n = 787 per arm: 0.800 (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

Multiplicity arises when statistical tests are conducted for more than one outcome, time point, subgroup, or analysis choice. In general, examining many results creates more opportunities for chance findings. A prespecified testing hierarchy or adjustment procedure can control how the family of tests is interpreted. The registry record lists multiple secondary outcomes, but a multiplicity procedure, outcome hierarchy, or plan for interpreting multiple tests is not reported in the registry record.

The primary comparison has an unadjusted p-value of 0.575 in the recalculation. The posted secondary comparisons also have unadjusted p-values, and the depressive-symptom estimate has an unadjusted p-value of 0.033. These calculations do not account for testing several outcomes. Without a reported multiplicity approach, the secondary p-values should not be treated as if each were the sole confirmatory test. The record lists six secondary outcomes, while numerical summaries are posted for three; the results for the other listed outcomes are not reported in the registry record.

Missing-data handling is not reported in the registry record. The numbers contributing to posted outcomes vary: the primary summaries include 32 and 31 participants, the respiratory summaries include 30 per group, and the depressive-symptom and fatigue summaries include 31 per group. Those counts do not by themselves explain why the numbers differ or whether any observations were missing. The record does not report imputation, complete-case analysis, sensitivity analyses, reasons for missing outcomes, or how participants with incomplete monitoring were handled.

The analysis population is also not reported in the registry record. It is not stated whether the primary analysis followed an intention-to-treat approach, included only participants with available outcome data, or used another population definition. The registry identifies randomization, but the posted summaries alone do not show whether all randomized participants were analyzed according to assigned group. No interim analyses or detailed statistical analysis plan are reported in the registry record. These omissions limit assessment of how outcome selection, missingness, and analysis decisions may affect the posted estimates.

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 registry record reports zero serious adverse events in each group: among 32 participants at risk in The BEST Program group and 31 participants at risk in the sleep education and standard-treatment group. It also reports zero other adverse events in the 32 and 31 participants at risk, respectively, and zero deaths in both groups. These figures describe the posted counts during the recorded safety assessment.

A zero count means no events of that category were reported among the listed participants at risk; it does not establish that an event is impossible or that the programs have no safety risks. The registry record does not provide event-specific descriptions because no serious adverse-event terms are listed. Details about the method and period of adverse-event collection, severity grading, relatedness assessment, or completeness of reporting are not reported in the registry record. The safety figures should therefore be read as counts in this record, not as a comprehensive estimate of risk.

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

The posted primary outcome compares average PAP-use nights over 90 days. The recalculated difference is 3.49 nights in favor of The BEST Program, but its 95% confidence interval ranges from -8.712 to 15.69 and its unadjusted p-value is 0.575. The data therefore do not provide a precise estimate of the difference between the assigned groups. The confidence interval includes no difference and values on either side, so the result should not be translated into a categorical claim that the programs are the same or that one is better.

The comparison is between a combined support and education program and sleep education with standard sleep-disordered breathing treatment. It does not isolate the contribution of any single program component. The posted primary measure captures device use meeting a specified duration on a night; it does not by itself establish a change in sleep quality, respiratory function, general functioning, or quality of life.

The registry summary describes anticipated benefits in several areas, but expectations are not trial findings. The posted secondary outcomes offer some additional numerical information, while results for other listed outcomes are not reported in the registry record. The secondary comparisons are unadjusted recalculations, and the record does not report how multiple outcomes were handled. This limits the strength of conclusions drawn from an isolated secondary result.

Statistical uncertainty is not the same as clinical uncertainty, and neither can be resolved without context about meaningful differences and the study’s analysis. The registry does not report a threshold for a clinically important change in adherence or the other measures. It also does not report the original sample-size justification, missing-data methods, or analysis population. The results support a description of the posted summaries and their precision, but not broader claims about effectiveness, equivalence, mechanisms, or the experience of every participant.

17. Why This Trial Matters Statistically

This trial raises a useful statistical distinction between an intervention’s intended mechanism and the outcome used to assess it. The BEST Program was designed to address challenges to PAP treatment through education, support, and training, while its primary endpoint counted nights meeting a device-use threshold. That endpoint is directly connected to adherence, but it is not interchangeable with sleep quality or wider functional outcomes. Keeping the measure and the broader aims separate prevents an adherence result from being overinterpreted as evidence about every hoped-for benefit.

The primary estimate also illustrates why a point estimate should not be read alone. The recalculated difference is 3.49 nights, but the confidence interval extends from -8.712 to 15.69. The range conveys substantial uncertainty about both direction and magnitude. A p-value alone would not communicate that range, and a non-significant result does not establish that the groups are equivalent.

The secondary results highlight another issue: interpreting several outcomes requires attention to multiplicity, measurement direction, and missing reporting. Numerical summaries are available for only some of the outcomes listed in the registry, and the record does not state how multiple testing was handled. The result is a partial and unadjusted picture rather than a fully documented analysis across all outcomes.

Finally, planning calculations based on an observed effect are not a record of the assumptions used to design the completed trial. Keeping those purposes separate matters when researchers use posted estimates to think about future studies. Such illustrations depend on their stated assumptions and on the observed effect used as a planning reference; they cannot substitute for the original design justification.

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 limitations of interpretation follow from the registry record. The primary estimate is recalculated from group summary statistics rather than presented as a reported inferential analysis. The record lists no reported analyses, and the original statistical analysis plan is not reported in the registry record. It is therefore not possible to determine whether the original analysis used baseline adjustment, another model, or a different analysis population.

The number of participants contributing to the posted summaries varies across outcomes, but the reasons are not reported in the registry record. Missing-data methods, participant flow, and the handling of incomplete remote monitoring are also not reported. This prevents assessment of whether missing outcomes could have affected the group comparisons.

The registry lists six secondary outcomes but posts numerical summaries for three. It does not report a multiplicity strategy, prespecified hierarchy, clinically important differences, or complete numerical results for all listed outcomes. Direction of benefit is not stated for every scale. As a result, the secondary findings cannot be treated as a complete, confirmatory assessment of the broader set of outcomes.

The primary outcome is bounded from 0 to 90 days, but individual distributions are not available in the registry record. Means and standard deviations alone do not reveal the frequency of very low or high values or the form of the distribution. The registry summary discusses anticipated follow-up at 6 months, whereas the posted primary outcome timeframe is 90 days; the relationship between these time references is not explained. Finally, details of randomization and masking procedures, adherence to assignment, and safety-event collection are not reported. These limitations restrict interpretation of the posted summaries without implying that unreported procedures were or were not conducted.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Treatment of Sleep-disordered Breathing in Patients With SCI — NCT02830074.
• Registry record last updated 2021-05-19; status last verified 2021-04.
• Results first posted 2021-04-22.
• 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, double-masked, parallel-group study with enrollment of 73. It compared The BEST Program, a combined PAP and education support program, with sleep education and standard sleep-disordered breathing treatment.

The primary endpoint was the number of nights with at least 4 hours of PAP use during the first 90 days, measured by remote monitoring. The group means were 22.03 and 18.54 nights. The recalculated unadjusted mean difference was 3.49 nights, with a 95% confidence interval from -8.712 to 15.69 and unadjusted p-value 0.575.

Numerical secondary summaries are posted for respiratory function, depressive symptom severity, and fatigue symptoms. Results for other listed secondary outcomes and details of the original analysis plan are not reported in the registry record. Zero serious adverse events, other adverse events, and deaths were reported in each group among the listed participants at risk.