Impact of Sleep Restriction on Performance in Adults: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Impact of Sleep Restriction on Performance in Adults (NCT02960776), a randomized na study. The primary outcome is Endpoint Fat Volume.

2. Clinical Question

The registry record describes a study of adults examining sustained sleep restriction and outcomes that include mood, cognitive and physical performance. Its primary endpoint was fat volume measured by MRI. The posted primary outcome data are from 38 women who underwent MRI scanning for body composition assessment. The central statistical question is whether mean endpoint fat volume differed between the habitual-sleep and sleep-restriction conditions, and how precisely that difference was estimated.

The posted mean difference is expressed as SR minus HS. It is an endpoint comparison, not a description of change from baseline: although the endpoint description says body composition was measured at baseline and endpoint, the posted primary outcome is identified as endpoint fat volume. The registry record does not report a separate baseline-adjusted estimate or a detailed statistical model.

3. Trial Design

This was a randomized, unmasked crossover study sponsored by Columbia University. The record identifies the study as completed and gives an enrollment of 45. In a crossover design, participants receive or experience more than one condition, so each participant may contribute data under multiple conditions. The registry describes both a habitual-sleep phase and a sleep-restriction phase. It does not report the assignment sequence, the timing of any transition between phases, or whether the analysis accounted for within-participant pairing.

During the HS phase, participants were asked to keep a fixed bedtime routine based on their regular bed- and wake-times. During the SR phase, they were asked to maintain their habitual wake time and delay bedtime to achieve a reduction of 1.5 hours in total sleep time. These are the behavioral conditions described in the record; adherence measurements and the extent to which participants achieved the intended sleep reduction are not reported in the registry record.

The primary endpoint was measured at Week 6 (endpoint), and MRI body-composition measurements are described as occurring at baseline and endpoint. The primary outcome population is stated to comprise 38 women with available MRI data. The record does not explain how that population relates to the overall enrollment, nor does it state whether all randomized participants were included in a particular analysis population.

The study lists secondary outcomes covering energy expenditure, physical activity, appetite-related measures, brain activation in response to food stimuli and sedentary behavior. The registry record does not report the detailed statistical analysis plan, the rationale for the sample size, the planned treatment of period or sequence effects, or interim analyses. Those design and analysis details should not be inferred from the crossover label alone.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Overall Study

Analysis population for the primary outcome, as defined in the registry: Data were available from 38 women who underwent MRI scanning for body composition assessment.

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 Endpoint Fat Volume, measured over Week 6 (endpoint).

The primary endpoint is fat volume, reported in liters as a mean with standard deviation. The registry describes body composition, specifically fat volume, as measured by MRI at baseline and endpoint; the stated primary time point is Week 6 (endpoint). MRI is the measurement method named in the record. The endpoint therefore represents a quantitative body-composition measure rather than a symptom rating or a time-to-event outcome.

Comparing endpoint means describes the average fat volume recorded under the two sleep conditions in the analyzed outcome groups. In the posted summaries, the HS mean is 24.0 liters with a standard deviation of 11.4, and the SR mean is 24.2 liters with a standard deviation of 11.6. The reported mean difference is 0.2 liters, with SR minus HS as the direction of comparison.

A continuous measure can retain gradations across participants, while a group mean provides a compact description of the center of the observed values. The standard deviation describes variation among those values; it is not the uncertainty interval for the mean difference. That uncertainty is represented separately by the confidence interval. The registry record does not describe whether baseline fat volume was used in an adjusted analysis, so the endpoint summaries should not be interpreted as a baseline-adjusted change estimate.

7. Results Posted in the Registry

• Sleep Restriction (SR): mean 24.20 versus 24.00 on control; difference 0.20 (95% CI -4.97 to 5.37), standardized effect d = 0.02; z-test p = 0.940.

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.

Energy Expenditure (EE)

• 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:
  • Sleep Restriction (SR): mean 2,476 versus 2,445 on control; difference 31.00 (95% CI -236.61 to 298.61), standardized effect d = 0.06; z-test p = 0.820.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sleep Restriction (SR) and the control. The interval gives the range of effects that remain compatible with the data.

Physical Activity

• 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:
  • Sleep Restriction (SR): mean 87.40 versus 86.10 on control; difference 1.30 (95% CI -19.03 to 21.63), standardized effect d = 0.03; z-test p = 0.900.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sleep Restriction (SR) and the control. The interval gives the range of effects that remain compatible with the data.

Ghrelin

• 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:
  • Sleep Restriction (SR): mean 819.40 versus 856.60 on control; difference -37.20 (95% CI -173.23 to 98.83), standardized effect d = -0.12; z-test p = 0.592.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between Sleep Restriction (SR) and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary results cover energy expenditure, physical activity and ghrelin. Their mean-difference estimates vary in direction and scale, and their confidence intervals include zero. Taken together, the available summaries do not form a consistent pattern of clearly separated condition means. They also do not provide a more precise answer about the primary endpoint, because each secondary measure concerns a different outcome and has its own uncertainty.

The primary outcome concerns MRI-measured fat volume at endpoint. The secondary outcomes describe other measures, including energy expenditure and activity, rather than replacing or directly validating the primary endpoint. A similar-looking result across different outcomes would not, by itself, establish that one measure explains another; the registry record does not report such an analysis. Other secondary outcomes listed in the record include appetite-related measures and regional brain activation in response to food stimuli, but detailed result summaries for all listed outcomes are not available in the registry entries.

Unadjusted secondary results carry less weight because a study can examine multiple outcomes, increasing the chance that some estimates appear unusual through sampling variation alone. Multiplicity adjustment or a prespecified hierarchy can help define how confirmatory claims are made, but the registry record does not report whether such a plan was used. The analysis listing contains no reported secondary analyses. The secondary summaries are therefore most responsibly read as descriptive evidence that accompanies the primary comparison, not as independent confirmation.

Differences in outcome-specific sample sizes also matter when comparing summaries. The number of observations varies across the posted secondary outcomes, and the registry does not explain why. Each estimate should be understood with its own uncertainty and data availability rather than treated as if every outcome involved the same participants or had equal precision. The available secondary pattern does not resolve the limitations of the primary estimate or the undocumented details of the crossover analysis.

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

• Energy Expenditure (EE)
• Physical Activity
• Ghrelin
• Regional Brain Activation in Response to Food Stimuli
• Sedentary Behavior
• Leptin
• Glucagon-like Peptide 1
• Orexin

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous and is summarized by a mean and standard deviation. A mean is the arithmetic average of the observed values; a standard deviation describes how dispersed individual values are around that average. The posted endpoint means are 24.0 liters for HS and 24.2 liters for SR, with standard deviations of 11.4 and 11.6, respectively. These descriptive statistics do not by themselves show how uncertain the difference between the condition means is.

What does a mean difference represent?

The mean difference compares the average outcome under one condition with the average under the comparator. Here the reported direction is SR minus HS, giving a mean difference of 0.2 liters. A positive value means the SR mean is higher than the HS mean in this comparison; a negative value would mean it is lower. This direction is only a description of the estimate and does not indicate whether a difference is important or caused by the condition.

The registry labels the study as a randomized crossover. In general, crossover data can contain repeated observations from the same participants under different conditions. Accounting for that pairing can affect both the estimated uncertainty and the analysis. The registry record does not report whether the primary comparison used paired data, a crossover-specific model, or an adjustment for period or sequence. It is therefore not possible to attribute a specific method to the reported comparison.

What does the confidence interval add?

A confidence interval gives a range of values compatible with the data under the statistical procedure and its assumptions. It communicates precision as well as direction: a narrow interval gives a more constrained range, whereas a wide interval leaves more uncertainty about the size of the underlying difference. For fat volume, the posted interval for the mean difference is -4.971 to 5.371 liters. Because it includes zero, the result does not distinguish clearly between a difference in either direction and no difference under the interval procedure. The interval should not be read as a guarantee that the true value falls within those endpoints.

How should the p-value be understood?

The posted primary p-value is unadjusted and equals 0.94. In general, a p-value measures how unusual the observed data, or data more extreme, would be under a specified null hypothesis and statistical model. It depends on the model and assumptions; it does not measure the probability that the null is true, nor does it quantify the probability that a result will replicate. The registry record does not report a detailed test specification or adjustment for multiplicity.

For the secondary outcomes, the posted comparisons are also expressed as mean differences with confidence intervals and unadjusted p-values. The record reports no secondary analyses in its analysis listing. The available secondary estimates should therefore be read as descriptive posted comparisons, not as evidence that a particular prespecified model was used. In general, multiple outcomes create multiple opportunities for apparently notable results, and unadjusted p-values do not account for that multiplicity.

Why can over-dispersion matter?

General statistical explanation: when observed values vary more than a model assumes, standard errors can be too small and confidence intervals can be too narrow if the extra variability is ignored. The listed endpoint is continuous, and its observed standard deviations are reported. The registry record does not report a model that assumes a particular dispersion structure, nor does it report an over-dispersion assessment. This concept is relevant when evaluating model assumptions in general, but it should not be presented as a finding about this trial.

For a crossover analysis, a further general consideration is the dependence between measurements from the same participant. A method that treats repeated measurements as independent may not represent that dependence appropriately. Conversely, a paired analysis requires information about within-participant variation. The registry record does not report the paired differences or the covariance between conditions. The posted arm summaries alone cannot recover those features.

The registry also does not report the original sample-size justification, a full statistical analysis plan, interim analyses, a missing-data method, or a defined analysis population. These omissions limit assessment of whether the reported estimates correspond to the study's prespecified primary analysis. General statistical interpretation should remain conditional on those unknowns rather than filling them in by assumption.

11. Confidence Intervals and Precision

The primary mean difference is 0.2 liters, with a 95% confidence interval from -4.971 to 5.371 liters. The interval extends on both sides of zero, so the estimate does not precisely establish the direction of the difference. Its width indicates that the data are compatible with a range of possible differences, rather than tightly locating the underlying contrast near the point estimate.

The 95% confidence level describes the long-run coverage property of the interval procedure under its assumptions. In general, it does not mean there is a 95% probability that this particular fixed interval contains the true difference. The confidence interval is also not a range of individual participants' fat-volume values; those values vary around the means, as reflected in the reported standard deviations of 11.4 liters for HS and 11.6 liters for SR.

Precision depends on the number of observations and their variability, as well as the analysis design. The primary MRI population is reported as 38 women. Because the study is a crossover, within-participant correlation could affect precision, but the registry does not report the paired data or the model used to account for them. The confidence interval should therefore be interpreted as the interval attached to the posted mean-difference estimate, without assuming an undocumented analysis method.

The interval does not by itself determine whether the range is meaningful in practice. The registry record does not report a threshold for an important difference in fat volume. Nor does it report a baseline-adjusted estimate that might answer a different question from the endpoint comparison. Statistical uncertainty and practical importance are related but distinct considerations.

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 events. They are illustrations based on the observed effect, not a report of the trial's original design calculation. The stated assumptions are a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. Each planning row uses a stated fraction of the observed effect as the effect to detect. The trial's original sample-size assumptions are not reported in the registry record.

The 80% power column describes the number of participants per arm that the illustration estimates would be needed to have an 80% chance of detecting the selected effect under the stated assumptions. The 90% power column uses a higher target chance of detection, so its planning count is larger for the same effect. These are prospective planning quantities under a hypothetical design, not descriptions of what happened in the completed study.

For the primary endpoint, the illustration based on 100% of the observed effect gives 51,905 participants per arm for 80% power and 69,486 participants per arm for 90% power. Planning for 75% of the observed effect gives 92,275 and 123,530 participants per arm, respectively; planning for 50% gives 207,619 and 277,943 participants per arm. The direction of the pattern is important: smaller effects require more participants to detect under otherwise unchanged assumptions.

These planning figures are not observed power. They do not show the probability that this completed trial detected an effect, and they should not be interpreted as the number of participants the original investigators intended to enroll. The registry record reports enrollment of 45, while the primary MRI outcome population is 38 women; those observed counts are distinct from the hypothetical planning illustrations.

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 = 0.200; pooled standard deviation σ = 11.500.
2. n = 2 × (1.96 + 0.842)² × 11.500² / 0.200² = 51,904.6, rounded up to 51,905 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 <- 0.199999999999999                      # observed difference in means
sigma <- 11.5004347743901                     # 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(2960776)
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 = 51,905 (80% power), 69,486 (90% power)
 75% of observed effect: n per arm = 92,275 (80% power), 123,530 (90% power)
 50% of observed effect: n per arm = 207,619 (80% power), 277,943 (90% power)
power.t.test: 51905.6 
Simulated power at n = 51,905 per arm: 0.798 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

The registry lists multiple secondary outcomes, and the record states that 15 outcome measures were posted. Examining many outcomes raises a multiplicity issue: when many statistical comparisons are made, some may appear notable by chance even if there is no underlying effect. In general, a prespecified primary outcome and an explicit plan for handling secondary comparisons help readers distinguish confirmatory questions from exploratory ones. The registry record does not report a multiplicity adjustment, an outcome hierarchy, or a detailed statistical analysis plan.

The posted primary comparison has an unadjusted p-value. The secondary comparisons also have unadjusted p-values, and the registry lists no reported secondary analyses. Without a stated analysis plan, it is not possible to determine which comparisons were intended as confirmatory, whether results were selected for reporting, or whether any adjustment was used outside the record. These unknowns do not prove that a particular practice occurred; they limit what can be concluded from the registry information.

Missing-data handling is also not reported. The primary MRI outcome is described as available from 38 women, while the overall enrollment is 45. The registry record does not state why the numbers differ, whether the MRI observations were missing for some participants, or how any missing outcomes were handled. The secondary outcome summaries also have outcome-specific participant counts. Those differences should not be assigned a cause without documentation.

The analysis population is not fully defined beyond the statement about the women with MRI data. The record does not say whether the primary analysis included all randomized participants, only participants with observed MRI outcomes, or a different population. It does not describe imputation, sensitivity analyses, or assumptions about missingness. Nor does it provide the crossover-specific analysis details needed to assess whether all available repeated measurements were handled as planned. These reporting gaps make it harder to judge robustness and to reproduce the analysis from the registry record alone.

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 reports serious and other adverse-event counts separately for the two sleep conditions. For HS, 42 participants were at risk for serious adverse events and 0 were affected; 42 were at risk for other adverse events and 0 were affected. For SR, 39 were at risk for serious adverse events and 0 were affected; 39 were at risk for other adverse events and 0 were affected. The record lists no serious adverse-event terms.

These are reported counts within the stated at-risk groups. They do not establish that no events could occur, and zero recorded events should not be read as proof of absence of risk. The groups have different reported at-risk counts, and the registry record does not explain the difference or give further detail about event collection, follow-up, or attribution. No deaths are reported in either group.

Adverse-event counts are distinct from the primary outcome comparison. They do not provide evidence about the size or precision of the fat-volume difference. The record does not describe a causal assessment for individual events, so the counts should be read as registry safety reporting rather than as an assessment of whether an event was caused by a sleep condition.

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

The result describes an observed difference in mean endpoint fat volume between the sleep conditions among the participants represented in the posted MRI outcome data. The estimate is 0.2 liters for SR minus HS, with a 95% confidence interval from -4.971 to 5.371 liters. The interval includes zero and leaves uncertainty about the direction and size of the underlying difference. The unadjusted p-value is 0.94. Together, these statistics do not demonstrate a clear difference, but they also do not establish that the conditions are equivalent.

Equivalence requires a prespecified margin defining how small a difference must be to count as practically equivalent, together with an analysis designed to assess that question. The registry record does not report such a margin. A non-significant result is not, on its own, an equivalence finding. Likewise, the point estimate's closeness to zero does not eliminate the uncertainty conveyed by the interval.

The study is described as randomized and crossover, but the registry record does not report the analysis details needed to evaluate pairing, period effects or sequence effects. The primary outcome population consists of 38 women with MRI data, and the record does not report how missing outcomes were handled. These limitations affect how confidently the posted contrast can be interpreted as an estimate of the condition difference in the intended population.

The summaries concern a specific endpoint and timeframe. They do not establish results for every listed secondary outcome, every population, or other durations and settings. They do not provide a basis for individual medical decisions. The statistical result is best understood as an imprecise endpoint comparison in the analyzed MRI group, with important analysis and reporting details not stated in the registry record.

17. Why This Trial Matters Statistically

This trial is statistically instructive because its randomized crossover design and posted outcome summaries raise questions that cannot be answered from arm means alone. In crossover studies, the same participant may contribute information under multiple conditions. The handling of within-participant dependence can be central to estimating uncertainty, yet the registry record does not describe whether or how that dependence was included in the analysis.

The primary estimate also illustrates why a point estimate and its precision should be considered together. The mean difference is 0.2 liters, while the confidence interval extends from -4.971 to 5.371 liters. The estimate's direction and size alone do not convey how much uncertainty remains. The interval provides that context, while the unadjusted p-value is only one summary under a statistical model.

The record further shows the distinction between observed outcomes and planning illustrations. The trial's enrollment and the MRI population describe the study data, whereas the sample-size illustrations use hypothetical assumptions and the observed effect. Those planning values are not observed power and do not reveal the investigators' original design rationale. The original sample-size justification is not reported in the registry record.

Finally, multiple outcomes and incomplete analysis reporting make restraint important. The record lists numerous outcome measures, but does not document multiplicity handling, missing-data methods, or a full statistical analysis plan. These are not minor technicalities: they shape how a result should be interpreted and how reproducible its analysis is. The trial is therefore a useful example of reading estimates in the context of design, precision, and reporting limits, rather than treating a single p-value as a complete account.

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.

The primary result is based on MRI data reported as available from 38 women, while total enrollment is 45. The registry record does not explain this difference, define the primary analysis population in greater detail, or report how missing data were handled. The endpoint description notes measurements at baseline and endpoint, but the posted primary result is endpoint fat volume. No baseline-adjusted comparison is reported.

The crossover design creates a specific interpretive limitation: the record does not describe treatment order, period effects, sequence effects, or whether the analysis accounted for paired measurements. Without those details, readers cannot determine from the registry record whether the uncertainty estimate reflects the dependence expected in a crossover study. The record also does not state whether participants achieved the intended reduction of 1.5 hours in total sleep time.

The statistical analysis plan, original sample-size justification, interim analyses, multiplicity strategy and clinically important difference threshold are not reported in the registry record. The posted p-values are unadjusted. Multiple listed outcomes and the lack of a documented testing hierarchy limit the strength of interpretations based on secondary findings.

Adverse-event counts are reported, but the record does not give details on event ascertainment, follow-up or attribution. Secondary summaries are available for only some outcomes in the registry entries, and their participant counts vary. The registry record does not explain the variation. These are limitations of the information reported; they should not be replaced with assumptions about study conduct or data quality.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Impact of Sleep Restriction on Performance in Adults — NCT02960776.
• Registry record last updated 2025-04-03; status last verified 2025-03.
• Results first posted 2024-07-09.
• 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

NCT02960776, titled “Impact of Sleep Restriction on Performance in Adults,” is a completed, randomized, unmasked crossover study sponsored by Columbia University. Its official title is “Effect of Long Term Sleep Restriction on Energy Balance.” The record gives enrollment as 45 and describes habitual sleep and sleep restriction conditions. Participants in the sleep-restriction phase were asked to delay bedtime while maintaining their habitual wake time, with a target reduction of 1.5 hours in total sleep time.

The primary outcome was endpoint fat volume measured by MRI at Week 6. Data were available from 38 women. The posted mean difference for SR versus HS is 0.2 liters, with a 95% confidence interval from -4.971 to 5.371 liters and an unadjusted p-value of 0.94. The registry also lists secondary outcomes, including energy expenditure, physical activity and ghrelin. Detailed statistical methods, missing-data handling, multiplicity procedures and the original sample-size justification are not reported in the registry record.