Sleep, Mental Fatigue, and Performance in Students
NCT07644611, Recruiting, L.U.de.S. Sagl
Trial 8
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Sleep, Mental Fatigue, and Performance in Students | ClinicalTrials.gov |
| NCT number | NCT07644611 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | L.U.de.S. Sagl | ClinicalTrials.gov |
| Conditions | Mental Fatigue, Sleep and Circadian Problems | ClinicalTrials.gov |
| First posted | 2026-06-12 | ClinicalTrials.gov |
| Last updated | 2026-09-03 | ClinicalTrials.gov |
Registered outcomes 13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Subjective mental fatigue | Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment; assessed immediately before and immediately after each session over the study period. | Measured with a 0-100 mm visual analogue scale anchored by "none at all" and "maximal." Participants mark their current level of mental fatigue, and the score is calculated as the distance in millimeters from the zero point to the participant's mark. Higher scores measure in arbitrary units (a.u.) indicate greater fatigue. | ClinicalTrials.gov |
| Primary | Cognitive performance | Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment; assessed immediately before and immediately after each session over the study period. | Measured with a Stroop task delivered through a tablet-based application. The task includes congruent/control trials and incongruent trials in which participants must identify the font color while ignoring conflicting word meaning. Performance is quantified by reaction time in milliseconds (ms) for correct responses and accuracy in percentage (%). Faster reaction times and higher accuracy indicate better cognitive performance. | ClinicalTrials.gov |
| Secondary | Sleepiness | Pre- and post-session during teaching (T1) and exam (T2) sessions; also assessed at sleep/wake points during the monitoring period (the week in which T0 occurs). | Measured with the Karolinska Sleepiness Scale (KSS), a 9-point scale ranging from 1 ("very alert") to 9 ("very sleepy, fighting sleep"). Participants report their current level of sleepiness. Higher scores measured as arbitrary units (a.u.) indicate greater sleepiness. | ClinicalTrials.gov |
| Secondary | Motivation | Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment. | Measured with the Motivational States Scale, a 15-point Likert-type scale that captures task engagement, distress, and worry. It is used to assess the participant's immediate motivational state before a specific task. Higher or lower scores are measured as arbitrary units (a.u.) and interpreted according to the subscale direction used in the instrument foe each subscale (i.e., engagement, distress, and worry). | ClinicalTrials.gov |
| Secondary | Physical performance: handgrip strength | Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment. | Measured using a hand dynamometer on the dominant hand. Participants squeeze the device as hard as possible for 3 seconds, three times, with 60 seconds of rest between trials. The average of the three trials is used as the maximal strength score in kilograms (kg). The instrument allows measurements from 0 to 90kg and higher values indicate greater grip strength. | ClinicalTrials.gov |
| Secondary | Physical performance: handgrip endurance | Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment. | Measured after the maximal strength trials by having participants maintain a target force equal to 45% of their maximal force for as long as possible. Endurance time in seconds (s) is recorded until task failure, defined as force dropping below 45% of the target for more than 3 seconds. Higher times indicate better endurance. | ClinicalTrials.gov |
| Secondary | Perceived exertion | During each handgrip endurance test (pre- and post-session) at baseline (T0), teaching (T1), and exam (T2) sessions. | Measured during the handgrip test with the CR-10 Rating of Perceived Exertion scale, ranging from 0 ("no effort at all") to 10 ("extremely strong effort"). Participants rate how hard the handgrip task feels. Scores are expressed in arbitrary units (a.u.), with higher scores indicating greater perceived effort. | ClinicalTrials.gov |
| Secondary | Bedtime, wake time, time in bed, sleep onset, and sleep offset | Five consecutive nights at the week in which the baseline (T0) occurs; three nights before and two nights after the teaching (T1) session; three nights before and two nights after the exam (T2) session. | Measured using wrist actigraphy and daily sleep diaries. Variables such as bedtime (the time when the participant attempts to go to sleep), wake time (the time when the participant gets out of bed), time in bed (the total duration from bedtime to wake time), sleep onset (the time when sleep actually begins), and sleep offset (the time when sleep ends) are measured in hours:minutes (h:mm). | ClinicalTrials.gov |
| Secondary | Sleep efficiency and fragmentation index | Five consecutive nights at the week in which the baseline (T0) occurs; three nights before and two nights after the teaching (T1) session; three nights before and two nights after the exam (T2) session. | Measured using wrist actigraphy and daily sleep diaries. Variables such as sleep efficiency (the percentage of time in bed that the participant is actually asleep) and fragmentation index (a measure of sleep continuity reflecting the frequency of awakenings and restlessness during sleep) are measured as percentage (%). | ClinicalTrials.gov |
| Secondary | Sleep latency, wake after sleep onset, total sleep time, immobility time, naps, and nocturnal awakenings | Five consecutive nights at the week in which the baseline (T0) occurs; three nights before and two nights after the teaching (T1) session; three nights before and two nights after the exam (T2) session. | Measured using wrist actigraphy and daily sleep diaries. Variables such as sleep latency (the time it takes to transition from wakefulness to sleep after bedtime), wake after sleep onset (the total duration of awakenings after initially falling asleep), total sleep time (the actual amount of time spent asleep during the night), immobility time (the total duration of uninterrupted sleep without movement), naps (the duration of daytime sleep episodes), and nocturnal awakenings (the duration of wakefulness during the night after sleep onset) are measured in minutes (min). | ClinicalTrials.gov |
| Secondary | Chronotype | At the week in which occurs the baseline (T0). | Measured with the Morningness-Eveningness Questionnaire (MEQ), which assesses chronotype. Scores are expressed in arbitrary units (a.u.), with higher scores indicating a more morning-type preference and lower scores indicating a more evening-type preference. The total score ranges from 16 to 86, with score bands commonly interpreted as definite evening (16-30), moderate evening (31-41), intermediate (42-58), moderate morning (59-69), and definite morning (70-86). | ClinicalTrials.gov |
| Secondary | Sleep quality | At baseline (T0) referring to the previous month. | Measured with the Pittsburgh Sleep Quality Index (PSQI), which assesses overall sleep quality over the previous month. The total score is expressed in arbitrary units (a.u.) and ranges from 0 to 21, with higher scores indicating poorer sleep quality and lower scores indicating better sleep quality. A global PSQI score greater than 5 is commonly used as the cutoff to identify poor sleepers. | ClinicalTrials.gov |
| Secondary | Academic achievement | At the exam (T2) session. | Measured as the participant's final exam grade when an exam session is available. The score is on the Swiss 1-6 grading scale (unit: points), ranging from 1.0 (lowest possible) to 6.0 (highest possible), with 4.0 as the minimum passing grade. Higher scores indicate better performance, with 6.0 representing excellent performance and grades below 4.0 indicating failure. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 17
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 1027738 | BACKGROUND | PubMed |
| 2062970 | BACKGROUND | PubMed |
| 2265922 | BACKGROUND | PubMed |
| 2748771 | BACKGROUND | PubMed |
| 12209117 | BACKGROUND | PubMed |
| 12749557 | BACKGROUND | PubMed |
| 12899368 | BACKGROUND | PubMed |
| 16564189 | BACKGROUND | PubMed |
| 28044281 | BACKGROUND | PubMed |
| 33440343 | BACKGROUND | PubMed |
| 33666165 | BACKGROUND | PubMed |
| 35708888 | BACKGROUND | PubMed |
| 38621290 | BACKGROUND | PubMed |
| 40271358 | BACKGROUND | PubMed |
| 40417017 | BACKGROUND | PubMed |
| 40771318 | BACKGROUND | PubMed |
| 41112567 | BACKGROUND | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)