This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Poor Sleep and Inflammation in HIV-Infected Adults (NCT03848325), a na na study. The primary outcome is Soluble CD14.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03848325 |
| Phase | NA |
| Condition | HIV-1-infection, Sleep Deprivation, Inflammation |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 20 |
| Arms in the primary outcome | n/a |
| Lead sponsor | University of Pittsburgh |
| Results posted | Yes |
2. Clinical Question
Population
Adults with HIV-1 infection. The registry record describes a study of people living with HIV and records an enrollment of 20. It does not report further eligibility details or a fuller description of the enrolled population in the information available for this analysis.
Intervention
Sleep deprivation. Participants first had an 8 hour opportunity for sleep, followed by an outcome assessment the next morning. They were then kept awake for the subsequent 24 hours, including Night 2, with assessment the following morning.
Comparator
The baseline sleep-replete state is the within-study reference condition. This is not a separate randomized control group: the registry describes a single-group, nonrandomized study in which the same participants were assessed around the sleep-deprivation period.
Primary question
How does plasma soluble CD14 concentration, measured in ng/mL, differ between the baseline sleep-replete state and the state after 24 hours of sleep deprivation? The rationale concerns whether acute sleep deprivation is accompanied by a peripheral adenosine response and changes in systemic inflammation. The registry record does not report the measured change in soluble CD14.
3. Trial Design
This is a completed, single-group behavioral study registered as NCT03848325, with an enrollment of 20. The registry lists the phase as NA, allocation as NA, and masking as none. Those entries do not describe a randomized comparison or a blinded treatment assignment. The record explicitly characterizes the arms as not being a like-for-like control comparison.
The study sequence uses participants as their own reference. All subjects were to have an 8 hour opportunity for sleep on Night 1, with outcome assessment the following morning on Day 1. They were then kept awake for the subsequent 24 hours, including Night 2, followed by assessment the next morning on Day 2. The primary endpoint timeframe is described as baseline sleep replete state and after 24 hours of sleep deprivation.
The registry lists the study start as 2020-11-09, primary completion as 2022-07-31, and status as completed. Its intervention is sleep deprivation, classified as behavioral. This design can describe measurements over the stated sequence, but the record does not establish that any observed difference would be attributable only to sleep deprivation. Without a separate comparison condition, changes over time, measurement conditions, or other influences cannot be separated by a randomized between-group contrast.
The registry record does not report the statistical analysis plan, a sample-size justification for the trial, or whether any interim analyses were planned. It also does not report a detailed protocol for the outcome-assessment procedures beyond the timing and sleep conditions.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Sleep Repletion Followed by Sleep Deprivation |
|---|---|
| STARTED | 20 |
| COMPLETED | 20 |
| NOT COMPLETED | 0 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Baseline (Sleep Repletion) Followed by Sleep Deprivation |
|---|---|---|
| Participants analysed | 20 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 15 |
| Age, Categorical: >=65 years | Participants | 5 |
| Age, Continuous | years | 61.1 (SD 9.7) |
| Sex: Female, Male: Female | Participants | 5 |
| Sex: Female, Male: Male | Participants | 15 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 20 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 1 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 7 |
| Race (NIH/OMB): White | Participants | 10 |
| Race (NIH/OMB): More than one race | Participants | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Region of Enrollment: United States | participants | 20 |
6. Primary Endpoint
The registry lists the primary outcome as Soluble CD14, measured over Baseline sleep replete state and after 24 hours of sleep deprivation.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | ng/mL |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is plasma concentration of soluble CD14, reported in ng/mL. The registry specifies a continuous measure summarized by a mean and standard deviation. Its timeframe compares the baseline sleep-replete state with the state after 24 hours of sleep deprivation.
The endpoint is relevant to the study’s stated interest in systemic inflammation. The record’s rationale proposes that sleep deprivation in people living with HIV may fail to produce an appropriate peripheral adenosine response, potentially accompanying increased inflammation and endothelial dysfunction. Soluble CD14 is the registered primary measure used to examine an inflammatory aspect of that question. The record does not provide a more detailed account of why this marker was selected or how it relates to other biological measures in the study.
As a general statistical point, a continuous biomarker can be summarized by its mean to describe the average measured level, while its standard deviation describes variability among measurements. Neither summary alone establishes whether a change is precisely estimated or whether it is important beyond the measured biomarker. That assessment would require the endpoint values and an analysis of the change, neither of which is reported in the registry record.
The endpoint is a laboratory measure, not a clinical event or a direct measure of cardiovascular disease. A result for soluble CD14 would therefore address this specific biological measurement under the stated conditions, rather than by itself resolving broader clinical questions.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies soluble CD14 as the primary endpoint and gives its unit, summary measure, and assessment timeframe. It does not report a baseline mean, a post-deprivation mean, a standard deviation, an estimated change, a confidence interval, or a test result. The direction and magnitude of any change therefore cannot be established from the record, and its precision cannot be assessed.
The record lists 0 analyses. This means there is no reported primary-endpoint analysis in the registry information available for interpretation. It would not be appropriate to infer a result from the study rationale, the completed status, or the enrollment entry. A biological hypothesis is a proposed explanation to be tested; it is not evidence that the proposed response occurred.
Because the design follows a single group across baseline and sleep deprivation, the natural contrast is within participants. Such a contrast can account for stable differences between people when the same individuals contribute both measurements, but it does not remove all sources of uncertainty. Changes in measurement conditions, time, or other factors could accompany the sleep condition. A separate randomized control condition would be needed to support a different kind of causal comparison; this record does not describe one.
For any numerical change estimate, a confidence interval would communicate the range of values compatible with the data under the analysis assumptions. A narrow interval would indicate greater precision than a wide interval, but neither width nor a significance test alone determines clinical importance. No interval or test is reported for the primary endpoint, so neither precision nor statistical evidence for change can be judged.
The registry also names secondary measures involving flow-mediated brachial artery dilation, monocyte expression of IL6 and TNF-alpha, and T-cell activation markers. The presence of these outcomes indicates broader measurement interests, but the record does not report their results or analyses. They cannot be used to fill in the missing primary-endpoint result or to establish a coordinated biological pattern.
The posted information supports a description of the study question and sequence, not a conclusion about whether soluble CD14 rose, fell, or remained similar after sleep deprivation. Any interpretation of the primary result must await endpoint data and an analysis that describes the within-person change and its uncertainty.
9. Statistical Methods Explained
The registry describes a continuous primary measure summarized by a mean and standard deviation. These are descriptive statistics: the mean gives the average concentration in the observations being summarized, while the standard deviation describes how dispersed those observations are around the mean. They do not, by themselves, quantify uncertainty in an estimated change between conditions.
What comparison fits the study sequence?
Because the record describes assessment of the same subjects at baseline and after sleep deprivation, a within-person comparison is the natural way to express the study question. For each participant with both measurements, the analysis could consider the post-deprivation value relative to that participant’s baseline value. Summarizing those individual changes would address the average change over the observed sequence. This is a general description of a possible analysis, not a claim that the registry used it; the analysis method is not reported in the registry record.
A paired analysis and an analysis that treats the two sets of measurements as independent answer different statistical questions. The paired approach uses the relationship between measurements from the same person. Ignoring that relationship can misrepresent the uncertainty of the average change. The registry does not state whether the analysis accounted for pairing, how incomplete pairs were handled, or whether any adjustment for other variables was planned.
What would uncertainty add?
A point estimate describes the change calculated from the observed data. A confidence interval adds information about its precision under the chosen statistical model and assumptions. If the interval is wide, the estimate is compatible with a broad range of changes; if it is narrow, the compatible range is more limited. A confidence interval does not guarantee that the model is correct, and it does not establish that a measured change is clinically meaningful. No point estimate or confidence interval for soluble CD14 is reported in the registry record.
A hypothesis test, if conducted, would assess compatibility between the data and a specified null hypothesis under its assumptions. A test result alone would not communicate the magnitude of a change or its precision. The registry does not report a test, a p-value, or the statistical plan that would define the hypothesis and analysis.
Why examine distributions and assumptions?
For continuous measurements, analysts generally inspect the data and assess whether the chosen model describes them adequately. Means and standard deviations can be informative, but a small or irregular dataset may be sensitive to unusually high or low observations. The relevance of that concern cannot be evaluated without the measured values or distributions, which are not reported in the registry record.
General statistical guidance also distinguishes variability among observations from uncertainty in a mean or mean change. A standard deviation describes the spread of individual measurements. A standard error or confidence interval describes uncertainty in an estimated quantity under a model. They are not interchangeable. The registry specifies standard deviation as the dispersion measure but does not report the actual values or an uncertainty measure for the endpoint contrast.
How should the planning illustrations be read?
The planning assumptions describe illustrations based on a stated fraction of an observed effect, a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Such calculations are hypothetical planning illustrations, not observed power and not evidence that the study had a particular probability of detecting an effect. They do not replace the trial’s own design rationale, which is not reported in the registry record.
Those assumptions also do not describe the registered study sequence as a design with two equally allocated arms. The record identifies a single-group study and says the arms are not a like-for-like control comparison. Accordingly, an equal-allocation illustration should not be read as a description of how this study assigned participants or as confirmation of the analysis actually performed. The record does not report the trial’s sample-size justification.
What can be concluded from the registered methods?
The registry supports a description of the intended measurement schedule and the primary outcome definition. It does not identify the estimator for change, model, hypothesis test, uncertainty interval, handling of missing measurements, or analysis population. These omissions matter because different reasonable choices can produce different estimates or uncertainty statements. Without those details and the outcome data, statistical interpretation must remain limited to the design description and the questions the study was intended to address.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary endpoint and lists secondary outcomes that include flow-mediated brachial artery dilation, monocyte expression of IL6 and TNF-alpha, and CD4+ and CD8+ T-cell expression of HLA-DR and CD38. It also records 13 outcome measures. Considering multiple outcomes can raise a multiplicity issue: when many hypotheses are examined, the chance of at least one apparently noteworthy result can increase. This is a general statistical concern, not evidence that any result in this study is misleading.
The registry record does not report a multiplicity adjustment, a hierarchy among secondary outcomes, or a prespecified strategy for interpreting multiple tests. It also lists 0 analyses, so there are no reported outcome tests from which to assess how multiplicity was handled. The primary endpoint’s status is clear in the registry, but the planned inferential role of the secondary measures is not.
Missing-data methods and the analysis population are not reported in the registry record. The enrollment entry does not establish how many participants contributed each endpoint, whether every measurement was available at both assessments, or how any missing values were treated. Those details matter in a repeated-measure design because an incomplete set of paired observations can affect which participants contribute to an estimated change and the precision of that estimate.
The registry record also does not report whether analyses were conducted according to a prespecified protocol or whether deviations occurred. These missing details limit reproducibility and make it difficult to distinguish confirmatory analyses from exploratory ones. They do not show that data were missing or that any particular analysis choice was made.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Baseline (Sleep Repletion) Followed by Sleep Deprivation | 0 | 20 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Baseline (Sleep Repletion) Followed by Sleep Deprivation | 0 of 20 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Baseline (Sleep Repletion) Followed by Sleep Deprivation | 1 of 20 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Baseline (Sleep Repletion) Followed by Sleep Deprivation |
|---|---|---|
| Petechiae | Skin and subcutaneous tissue disorders | 1 of 20 |
The registry lists adverse-event figures for the group titled Baseline (Sleep Repletion) Followed by Sleep Deprivation. It records 20 subjects at risk for serious adverse events and 0 affected. For other adverse events, it records 20 at risk and 1 affected. The deaths field is 0. These are the registry’s reported counts; they do not describe event types, timing, severity details, or participant-level narratives.
The record lists no top serious adverse-event terms. The figures should be read as safety reporting entries, not as a complete account of every possible symptom or event during the study. The registry’s risk denominators and affected counts do not establish whether an event was related to sleep deprivation, and the record does not provide a causal assessment.
Zero recorded serious events does not prove that serious events are impossible or that risk is absent. In general, a small study may provide limited information about uncommon harms. The posted figures are descriptive and should not be treated as a comparative safety estimate: the study does not include a separate like-for-like control group in the registry record.
12. What the Result Does, and Does Not, Mean
The study addresses a focused biological question: whether soluble CD14, a plasma measure selected in the context of systemic inflammation, differs between a sleep-replete baseline and assessment after 24 hours of sleep deprivation in adults with HIV-1 infection. The registry describes the exposure sequence and identifies the primary outcome. It does not report the outcome values or an analysis of change.
Consequently, the posted record does not show whether soluble CD14 increased, decreased, or stayed similar. It also does not show how precisely any estimated change was measured. The proposed link among sleep deprivation, peripheral adenosine signaling, inflammation, and endothelial dysfunction is the study’s rationale and hypothesis, not a reported finding in this record.
Even if an endpoint result were available, a change in this biomarker would address the measured concentration under the study conditions. It would not by itself establish a change in cardiovascular outcomes, explain a biological mechanism, or show that the same pattern applies to people outside the enrolled study population. Such conclusions require evidence beyond a single biomarker contrast.
The single-group sequence can reveal how measurements differ across the stated conditions among participants with data, but it cannot provide a randomized contrast against a separate control condition. Other changes occurring over time or with the assessment sequence could contribute to a difference. The absence of a separate control does not make the observations unusable; it limits the causal interpretation that can be supported.
The appropriate reading is therefore narrow: the registry records a completed study with a defined primary measure and assessment schedule, but does not report the primary result. Claims about the direction, size, statistical significance, precision, or clinical implications of the endpoint are not supported by the registry record.
13. Why This Trial Matters Statistically
This study illustrates why design and results need to be read together. A clearly named endpoint and a defined assessment sequence identify what investigators intended to measure, but they do not reveal what the measurements showed. Without a reported estimate and its uncertainty, a reader cannot judge either the direction of change or how precisely it was measured.
The design also makes the comparison structure important. The same-participant sequence offers a natural within-person question, while the registry explicitly does not describe a randomized, like-for-like control comparison. Distinguishing these designs prevents a before-and-after contrast from being interpreted as if it were a controlled treatment effect.
The registry lists a primary endpoint alongside multiple secondary measures. That breadth may be useful for describing the study’s biological interests, while also making transparent analysis plans important. If multiple outcomes are tested, readers need to know which comparisons were prespecified and how multiplicity was considered. Those plans are not reported in the registry record.
Finally, planning illustrations should not be confused with study results or observed power. The stated illustration assumptions concern hypothetical planning, while the study record describes a single-group sequence. This distinction is central to biostatistical interpretation: design assumptions, measured data, and inferential conclusions are separate elements, and the registry does not report all of them.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpreting results is that the registry record does not report primary endpoint values or an analysis. There is no mean at either assessment, estimated change, standard deviation value, confidence interval, or test result in the record. The completed status therefore cannot be taken as evidence that a particular biological effect was observed.
The design is single group and nonrandomized, with baseline sleep repletion followed by sleep deprivation. There is no separate control condition described as a like-for-like comparison. This limits the ability to separate an effect of sleep deprivation from changes related to time, order, or other conditions that accompany the sequence. The registry does not report details that would allow these influences to be assessed.
Enrollment is recorded as 20, but the record does not report outcome-specific participant counts or whether both measurements were available for each person. Missing-data handling and the analysis population are not reported. These gaps prevent assessment of how complete the endpoint dataset was or how missing observations might affect an estimate.
The statistical analysis plan, sample-size justification, and interim-analysis plans are not reported in the registry record. The listed planning assumptions are illustrative and do not establish the rationale or operating characteristics of the study’s actual design. Multiplicity handling for the primary and secondary outcomes is also not reported.
Finally, the endpoint is a plasma biomarker within a study focused on sleep and inflammation in HIV-1 infection. The record does not report clinical outcomes or enough population detail to judge how broadly any eventual finding would apply. These limits concern what can be concluded from the registry information; they do not establish that the study was conducted incorrectly.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Poor Sleep and Inflammation in HIV-Infected Adults — NCT03848325.
- Registry record last updated 2023-11-29; status last verified 2023-11.
- Results first posted 2023-10-12.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT03848325, titled Poor Sleep and Inflammation in HIV-Infected Adults, is listed as completed and sponsored by the University of Pittsburgh. The registry records an enrollment of 20, a start date of 2020-11-09, and a primary completion date of 2022-07-31. The phase and allocation are listed as NA, masking as none, and the model as single group.
The behavioral intervention is sleep deprivation, following an 8 hour opportunity for sleep and baseline assessment, then a subsequent 24 hours awake and a further assessment. The primary measure is plasma soluble CD14 in ng/mL, summarized as a mean with standard deviation, with a timeframe of baseline sleep replete state and after 24 hours of sleep deprivation.
The registry record lists 13 outcome measures and 0 analyses. It does not report the primary endpoint results, statistical analysis plan, missing-data methods, or analysis population. The available information supports interpretation of the registered question and design, but not a conclusion about the measured change.