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 Sleep Treatment for Teens (NCT05397353), a na na study. The primary outcome is Insomnia Severity.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05397353 |
| Phase | NA |
| Condition | Sleep Problem, Suicidal Ideation, Suicide, Attempted |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 12 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Rutgers, The State University of New Jersey |
| Results posted | Yes |
2. Clinical Question
Population
The study description concerns adolescents aged 14–18 who were recently hospitalized for suicide risk and had co-occurring insomnia. The study aimed to examine a digital insomnia treatment during the post-hospitalization period. The registry record reports 12 enrolled participants; all 12 completed the baseline assessment. Eight participants completed the end-of-study assessment and were included in its summary statistics.
Intervention
The listed intervention is the Sleepio app, a digital cognitive behavioral therapy for insomnia program. The study description characterizes the program as six weekly sessions of 20 minutes each, alongside post-hospitalization treatment-as-usual. The registry record describes the app as the intervention received by participants, but does not report session attendance or individual adherence.
Comparator
There is no separate comparison group in the registry record. The design is listed as single group, with masking listed as none and allocation listed as not applicable. The main outcome is described at baseline and end of study, so those assessments can be considered at different times in the same study population, not as randomized treatment and control groups.
Primary question
The primary outcome is insomnia severity measured by the Insomnia Severity Index. The study asks whether this brief digital treatment can be evaluated in adolescents with insomnia following hospitalization for suicide risk, with insomnia severity assessed over the study period. The registry record does not report the numerical baseline or end-of-study mean, the size of any change, or an inferential analysis of change. It therefore does not establish a treatment effect against a control condition.
3. Trial Design
The registry lists Sleep Treatment for Teens as a completed, single-group study sponsored by Rutgers, The State University of New Jersey. The recorded start date is 2023-02-10, and the primary completion date is 2025-01-24. Enrollment is 12. The study is listed as having no masking, and allocation is not applicable. These design details describe a small study without a randomized comparison arm.
The study description proposes a two-site pilot involving Rutgers and Old Dominion University. It describes digital cognitive behavioral therapy for insomnia using the Sleepio app, alongside post-hospitalization treatment-as-usual. The planned intervention is described as six weekly sessions of 20 minutes. The proposed participants are adolescents aged 14–18, recently hospitalized for suicide risk and experiencing insomnia. The description refers to a pilot target of 20 participants, while the registry record lists actual enrollment of 12. The enrollment figure is the number recorded for the completed study.
Assessments are described as occurring before treatment, during treatment, at the end of treatment, and at one-month follow-up. The primary outcome timeframe is baseline and end of study, up to 10 weeks after baseline. The registry record says the Insomnia Severity Index was assessed weekly during treatment, but the primary outcome description identifies baseline and end-of-study scores as the results of interest. It reports that all 12 enrolled participants completed the baseline assessment and eight completed the end-of-study assessment, whose summary statistics include those eight participants.
The record lists two outcome measures and no analysis entries. Details of the statistical plan, including any planned approach to repeated assessments, are not reported in the registry record. The design can describe change over time within the enrolled group, but without a comparator it cannot separate a treatment-associated pattern from other explanations for change.
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 | Sleepio |
|---|---|
| STARTED | 12 |
| COMPLETED | 12 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: All 12 enrolled participants completed the baseline assessment. Eight participants completed the end-of-study assessment and were included in the end-of-study summary statistics.
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 | Sleepio |
|---|---|---|
| Participants analysed | 12 | |
| Age, Categorical: <=18 years | Participants | 12 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 3 |
| Sex: Female, Male: Male | Participants | 9 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 3 |
| Race (NIH/OMB): White | Participants | 6 |
| Race (NIH/OMB): More than one race | Participants | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Insomnia Severity, measured over Baseline and end of study (up to 10 weeks after baseline)..
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | Points on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is insomnia severity measured using the Insomnia Severity Index, or ISI. The registry describes it as a seven-item self-report measure. Its total score is calculated by summing the items, ranges from 0 to 28, and higher scores indicate greater insomnia severity. The endpoint is a continuous measure, with the registry identifying the mean and standard deviation as its summary statistics.
Insomnia severity is relevant to the study because the enrolled population is described as adolescents with co-occurring insomnia during the post-hospitalization period. A repeated measure of symptom severity can describe the group’s reported insomnia at different assessment times. The registry says the ISI was assessed weekly throughout treatment, while the primary endpoint focuses on baseline and end-of-study scores, with the latter assessed up to 10 weeks after baseline.
The registry record does not include the numerical baseline or end-of-study means or standard deviations. It also does not report a mean change, a confidence interval, or a test of change. Although the measure’s scoring range and direction are recorded, those properties alone do not show how participants’ scores changed. The end-of-study summary includes eight participants, whereas all 12 enrolled participants completed baseline assessment, so the two summary populations are not the same size.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies insomnia severity as the primary outcome and reports that 12 participants completed baseline assessment and eight completed the end-of-study assessment. It does not report the actual mean scores or standard deviations at either time point. No numerical change estimate, confidence interval, or test result is reported in the registry record. The direction and magnitude of any observed change therefore cannot be described from the posted outcome information.
This is a single-group study, not a randomized comparison. Baseline and end-of-study assessments can describe the enrolled participants at those times, but a difference between them, if one were available, would not by itself identify an effect attributable to the app. General statistical interpretation: over-time differences in a single group may reflect the intervention, other care, natural symptom fluctuation, changes in circumstances, or differences in who provided data at each assessment. Without a concurrent comparator, those explanations cannot be disentangled by a between-group comparison.
The end-of-study summary is based on eight participants, while baseline includes all 12 enrolled participants. This means a baseline group mean and an end-of-study group mean, if reported, would summarize groups with different membership. A comparison of those two group means would not necessarily equal the average within-person change among participants with measurements at both times. The registry does not report a paired-change estimate or explain how missing end-of-study assessments were handled.
The study description frames the project as a pilot intended to examine feasibility, acceptability, and effectiveness. However, the registry record lists two outcome measures and does not provide an analysis entry. The posted primary outcome description supplies the measure and assessment timing, but not numerical results. Feasibility and acceptability findings are not reported in the registry record. The absence of posted numerical outcome results is not evidence that scores were unchanged; it means the size and precision of any change cannot be assessed from this record.
General statistical interpretation: an estimate describes the direction and size of a result, while an uncertainty interval indicates how imprecisely that estimate is measured. Neither can be interpreted for this endpoint without the relevant result values. The enrolled sample is small, and the outcome summary at end of study includes only eight participants. This limits what can be learned about the distribution of scores and makes it especially important not to treat the observed participants as proof of a general pattern. No conclusion about treatment effectiveness relative to another intervention or usual care alone follows from these posted data.
9. Statistical Methods Explained
The registry identifies the primary outcome as a continuous score summarized by a mean and standard deviation. The outcome is the Insomnia Severity Index, whose total is formed by summing seven self-report items. The registry gives a score range of 0 to 28 and states that higher scores indicate greater insomnia severity. These are measurement and summary details; they do not constitute a complete statistical analysis plan.
What a mean and standard deviation describe
General statistical explanation: a mean is a measure of the center of a set of scores. A standard deviation describes how spread out the scores are around that mean. Reporting both can help readers distinguish a group with scores concentrated near its mean from one with more varied scores. For a continuous symptom measure, the mean can be useful for describing the group, while the standard deviation gives context about participant-to-participant variability. Neither summary alone describes the full score distribution or establishes a treatment effect.
The registry specifies these summary statistics but does not report their numerical values for baseline or end of study. It also does not report a numerical change estimate or the uncertainty around one. As a result, the endpoint’s measurement properties can be explained, but the observed level of insomnia severity and its change cannot be reconstructed from the registry record.
Repeated measurements and change
General statistical explanation: when the same participants are measured repeatedly, a within-person change analysis uses each participant’s measurements together. This preserves the pairing between a person’s baseline and later score. A comparison of separate group means at two time points is different: it summarizes each time point independently and may include different participants. In this study, all 12 enrolled participants completed baseline, while eight completed the end-of-study assessment. The registry does not report whether a paired analysis was conducted, nor does it provide individual paired data or a change summary.
The study description says the ISI was assessed weekly during treatment, and the primary outcome timeframe identifies baseline and end of study up to 10 weeks after baseline. Repeated measurements can help describe the course of scores over time, but they also require an analysis plan that addresses the dependence among measurements from the same person. The analysis plan and any model for repeated scores are not reported in the registry record. No weekly score results are given in the posted primary outcome description.
Uncertainty and inference
General statistical explanation: a confidence interval is a range of values compatible with the observed estimate under the assumptions of the method used. It expresses uncertainty in the estimate; it is not a range containing a known fraction of individual participants’ scores. A narrow interval generally indicates greater precision than a wide interval, but precision depends on the data and the analysis assumptions. The registry record does not report a confidence interval for the primary outcome or a test of change.
A significance test, when appropriate, evaluates data against a specified null hypothesis under a defined statistical model. A p-value is not the probability that a treatment works, nor does it measure the size or clinical importance of an effect. No p-value or inferential test for the primary outcome is reported in the registry record. The statistical plan and any assumptions used for inference are also not reported, so no significance-based conclusion can be drawn.
Why a comparator matters
General statistical explanation: a single-group before-and-after comparison can describe how measurements differ over time among participants with recorded data. It cannot, on its own, establish what would have happened to those participants over the same period without the intervention. A randomized comparator can help distinguish an intervention-associated difference from background changes and other influences. This registry lists a single-group model, with allocation not applicable and no separate comparator arm. Therefore, the design does not support a randomized treatment-versus-control estimate.
The study description says participants would receive the app plus post-hospitalization treatment-as-usual. The record does not provide a separate treatment-as-usual-only group. Since the outcome values and a change analysis are also not reported, the registry record cannot support an estimate of change attributable to the app, either against usual care or against no app.
Planning illustrations and observed evidence
General statistical explanation: sample-size planning uses assumptions about an effect, variability, significance level, and allocation to estimate how many participants a future study might require for a specified power. Such planning values are not observed participant outcomes, and they are not a measure of the probability that a result from this study is true. The registry’s planning description specifies a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and effects expressed as fractions of an observed effect. Those assumptions describe a planning illustration, not the single-group study’s design. The record does not report a sample-size justification for the trial itself.
The registry also specifies that planning illustrations for time-to-event outcomes use a total event count, while other illustrations use participants per arm. The primary endpoint in this study is continuous insomnia severity, and the registry lists a single-group design. The planning assumptions therefore should not be read as the study’s observed sample or as evidence of treatment effectiveness. No numerical planning output is reported in the registry record addressed by these outcome details.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists two outcome measures and no analysis entries. The primary measure described is insomnia severity on the Insomnia Severity Index. The other outcome measure and its results are not reported in the registry record. The record does not specify whether outcomes were ranked, whether a primary time point was selected for inferential testing beyond the stated baseline and end-of-study timeframe, or how multiple tests would be handled.
General statistical explanation: when many outcomes, time points, or statistical tests are examined, the chance of finding an apparently unusual result can rise. A prespecified analysis plan can identify which comparisons are primary and describe how multiplicity will be addressed. The registry record does not report such a plan or a multiplicity adjustment. Since no analysis entries are listed, there are no reported test results to evaluate for multiplicity.
Missing end-of-study data are relevant to interpretation. All 12 enrolled participants completed baseline assessment, while eight completed the end-of-study assessment and were included in that summary. The registry does not report why some participants lack end-of-study assessments, whether missingness was related to symptoms or participation, or what methods were used to handle missing data. It also does not report an analysis population definition beyond the stated baseline and end-of-study summary populations.
General statistical explanation: if participants with missing later measurements differ systematically from those with observed measurements, a summary among completers may not represent the full enrolled group. Methods for handling missing data rely on assumptions, and different assumptions can lead to different results. The registry does not describe any such assumptions, imputation, sensitivity analysis, or use of all available repeated observations. Consequently, the extent to which missing assessments could affect an estimate of change cannot be assessed from the posted record.
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 |
|---|---|---|---|
| Sleepio | 0 | 12 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Sleepio | 0 of 12 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Sleepio | 0 of 12 |
The serious adverse event figures list 12 participants at risk in the Sleepio group and zero affected by a serious adverse event. The figures also list 12 at risk for other adverse events and zero affected. Deaths are listed as zero. These are the registry’s event counts for the recorded group.
These counts should be read as reported events in this study, not as proof that an event is impossible or that the intervention has no risk. The record does not provide a list of serious adverse event terms, and no top serious-event terms are listed. It also does not give further details about how events were collected, the observation period for safety, or whether events were assessed as related to the intervention. Those details are not reported in the registry record.
General statistical explanation: a zero event count in a small study provides limited information about the frequency of uncommon events. A study with few participants may not observe an event even if it could occur in a larger population. The safety figures are therefore best understood as the counts recorded among participants at risk in this study, with the registry’s limited sample and reporting details kept in view. They do not permit a comparison of safety against a control group, because no separate control group is listed.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this completed study enrolled 12 participants in a single-group design and assessed insomnia severity at baseline and end of study. All 12 completed baseline assessment, while eight completed the end-of-study assessment and contributed to its summary statistics. The record describes the Insomnia Severity Index and its scoring direction, but does not report the numerical scores at either time point or a statistical analysis of change.
Accordingly, the posted information does not show whether insomnia severity increased, decreased, or remained similar over the observed period. It does not show the size or precision of a change, and it does not allow assessment of whether a change would be clinically meaningful. No conclusion about effectiveness relative to usual care alone or another treatment can be drawn because the registry lists no comparator arm and provides no inferential results.
The study description identifies feasibility, acceptability, and effectiveness as aims of a pilot. Those aims should be distinguished from the results that are actually reported. The record provides enrollment and assessment completion information, but no numerical findings for feasibility or acceptability. It also does not report app use or session completion. The absence of these details does not mean that no such information was collected; it means it is not reported in the registry record.
General statistical explanation: a small pilot can help characterize whether a larger study may be worth developing, but estimates from a small sample are often imprecise and may not represent a broader population. A single-group design can be useful for describing an observed course, but it cannot isolate the intervention’s contribution to that course. Here, the missing numerical outcome summaries further limit interpretation: even a descriptive within-group pattern cannot be quantified from the posted record.
The most defensible reading is therefore narrow. The registry documents a completed, single-group pilot with an insomnia severity outcome, baseline data from all enrolled participants, an end-of-study summary based on eight participants, and zero recorded adverse events in the listed categories. It does not provide the outcome values or analysis needed to estimate change or evaluate a treatment effect.
13. Why This Trial Matters Statistically
This study is statistically informative as an example of the gap between a study’s stated aims and the results available for interpretation. The registry describes a pilot intended to examine feasibility, acceptability, and effectiveness of digital cognitive behavioral therapy for insomnia in adolescents during a post-hospitalization period. It also records actual enrollment and completion of assessments. These details help readers understand the scope of the study and the amount of outcome information represented in the end-of-study summary.
The single-group design makes it important to distinguish description from causal inference. A baseline assessment and a later assessment can describe how measured insomnia severity varies over time. Without a comparator, however, such a pattern cannot isolate the contribution of the app from other factors. This distinction is central when a study is framed around treatment effectiveness: a before-and-after pattern is not equivalent to a randomized contrast.
Missing end-of-study assessments are another important statistical feature. Baseline measurements are recorded for all 12 enrolled participants, while the end-of-study summary includes eight. That difference in the available populations matters when interpreting any comparison across time. The registry does not explain missingness or describe a method for accounting for it, and the numerical outcome summaries are not reported. Readers therefore cannot judge either the size of a possible change or how robust it might be to missing data.
The study also illustrates why reporting estimates and uncertainty matters. A measure’s scale and direction explain what scores represent, but they do not substitute for the observed means, variation, change estimate, or uncertainty interval. Without those results, the record supports a description of the design and assessment flow, not a quantitative conclusion about outcome change.
These considerations are relevant beyond this particular study. Clear reporting of analysis populations, outcome summaries, missing-data handling, and comparator structure lets readers distinguish a promising research question from evidence that can answer it. In this record, those distinctions define what can and cannot be concluded.
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 primary limitation for interpreting the outcome is that numerical baseline and end-of-study scores are not reported in the registry record. The mean and standard deviation are identified as the intended summary statistics, but their values are absent. No change estimate, confidence interval, or inferential test is reported. Consequently, the magnitude, direction, and precision of any outcome change cannot be evaluated.
The study is listed as single group, with no allocation and no masking. No comparator group is recorded. Any difference over time, if one were reported, could not be separated from changes associated with other care, time, or participant circumstances. The study description includes treatment-as-usual alongside the app, but does not list a treatment-as-usual-only group.
The outcome summaries include different numbers of participants at baseline and end of study: 12 completed baseline assessment and eight completed the end-of-study assessment. The reasons for missing end-of-study assessments, the characteristics of participants without those data, and the approach to missing data are not reported in the registry record. This makes it difficult to determine how representative the end-of-study summary is of the enrolled group.
The registry describes weekly ISI assessment and a timeframe of baseline and end of study up to 10 weeks after baseline, but does not report weekly results or an analysis of repeated assessments. It also lists two outcome measures and no analysis entries; the other outcome measure and the statistical plan are not reported. The record does not provide session attendance, app adherence, or numerical findings about feasibility and acceptability, despite identifying these as study aims.
Finally, the registry’s description of a pilot target of 20 differs from its recorded enrollment of 12. The recorded enrollment describes the participants enrolled in the completed study; the target does not change the size of the observed outcome population. The record does not report a trial-specific sample-size justification.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Sleep Treatment for Teens — NCT05397353.
- Registry record last updated 2026-07-08; status last verified 2026-06.
- Results first posted 2026-07-08.
- 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
Sleep Treatment for Teens is listed as a completed, single-group study sponsored by Rutgers, The State University of New Jersey. The registry records 12 participants enrolled, no masking, and allocation as not applicable. The study description concerns adolescents aged 14–18 recently hospitalized for suicide risk with co-occurring insomnia, and lists the Sleepio app as the intervention.
The primary outcome is insomnia severity on the seven-item Insomnia Severity Index, with higher scores indicating greater severity. The assessment timeframe is baseline and end of study, up to 10 weeks after baseline. All 12 enrolled participants completed baseline assessment; eight completed the end-of-study assessment and were included in its summary statistics.
The numerical outcome summaries, an analysis of change, the statistical plan, and missing-data methods are not reported in the registry record. No separate comparator arm is listed. The adverse-event record lists zero serious adverse events, zero other adverse events, and zero deaths among the 12 participants at risk in the Sleepio group.