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Mental FatigueNCT07644611

Sleep, Mental Fatigue, and Performance in Students

An observational study of Mental Fatigue and Sleep and Circadian Problems, run by L.U.de.S. Sagl at 1 site in Switzerland.

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Trial summary

This observational, prospective, within-subject study will examine how the volume and timing of physiotherapy and psychology classes and exams at LUDES Institute influence mental fatigue, sleepiness, motivation, executive function, and physical performance in university students. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Fatigue, Sleep and Circadian Problems
How many people
30 participants
Where
1 siteSwitzerland
Study dates
1 Jul 2026to 20 Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The study population consists of undergraduate physiotherapy and psychology students enrolled at LUDES Institute (Lugano, Switzerland), who are at least 18 years old and regularly attending scheduled classes. Participants are recruited from cohorts currently following standard curricula and represent a mix of male and female students.

Who may be able to join

  • Enrolled as a physiotherapy or psychology student at LUDES Institute.
  • Age 18 years or older at the time of consent.
  • No self-reported major neurological disorders or conditions that would impair cognitive or physical testing.
  • Self-reported clinical sleep disorders.

Who cannot join

  • Use of psychostimulants (e.g., caffeine, energy drinks) before or during scheduled study sessions.
  • Vigorous exercise prior to testing sessions.
  • Melatonin intake.
  • Recent travel involving more than 3 time zones or shift/part-time shift work.
  • Absence from more than 25% of total scheduled lesson time

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jacopo A Vitale, Ph.D. contact

+41 799252830

Jacopo.VITALE@uniludes.ch

Dalton de Lima Junior, Ph.D. contact

dalton.delima@uniludes.ch

Switzerland1 site, 1 recruiting
  • LUDES - Istituto Universitario Professionale

    Lugano, Canton Ticino, 6912

    Jacopo A Vitale, Ph.D., +41 (0) 91 985.28.30, Jacopo.VITALE@uniludes.ch

    Recruiting

Other trials in Switzerland

About this study

Official title: Sleep, Mental Fatigue, and Performance: Psychobiological Insights for Optimizing Learning in Physiotherapy and Psychology Students

This observational, prospective, within-subject study will examine how the volume and timing of physiotherapy and psychology classes and exams at LUDES Institute influence mental fatigue, sleepiness, motivation, executive function, and physical performance in university students. Approximately 30 students aged 18 years or older will complete repeated assessments at baseline (no formal academic activities), during a regular theoretical class, and, when feasible, during an exam session.

At each time point, participants will undergo non-invasive measurements including self-reported mental fatigue (visual analogue scale), sleepiness (Karolinska Sleepiness Scale), motivation (Motivational States Scale), cognitive performance (Encephalapp Stroop task), and handgrip strength and endurance with perceived exertion ratings, alongside sleep diaries and wrist actigraphy. The primary endpoint is the pre-to post-session change in mental fatigue and cognitive performance, with secondary endpoints capturing sleep and circadian metrics, physical performance, motivation, and exam grades. Mixed-effects models will be used to test how class/exam duration, time of day, sleep quantity and quality, and chronotype relate to psychobiological responses, with the goal of informing evidence-based scheduling and workload policies in health-profession education.

Read the detailed description

Study overview

This is a prospective, observational, within-subject, repeated-measures, naturalistic case-crossover study involving physiotherapy and psychology students at LUDES Institute. The study focuses on how real-world academic demands (lectures and exams) interact with sleep, circadian rhythms, and mental fatigue to influence cognitive and physical performance. Each participant serves as their own control across three conditions: a baseline week without formal classes or exams, a typical theoretical class day, and, where applicable, an exam day.

The project is categorized as Category A (minimal risk and burden) under Swiss human research legislation and will be conducted in accordance with the Declaration of Helsinki, ICH-GCP (International Council for Harmonisation Good Clinical Practice), and applicable Swiss laws and guidelines.

Study objectives and hypotheses

The central objective is to characterize the psychobiological responses of physiotherapy and psychology students under varying academic pressures and schedules.

The study aims to:

Quantify changes in subjective mental fatigue, sleepiness, motivation, and objective cognitive and physical performance from before to after lectures and exams.

Evaluate how sustained cognitive demand across the university day affects psychomotor vigilance, executive control, and handgrip endurance.

Determine how sleep quantity and quality, as well as chronotype and time of day, moderate these responses.

Explore how the interaction between chronotype and timing of classes/exams relates to academic performance (exam grades) and perceived stress.

Key hypotheses include:

Longer classes and exam sessions will be associated with greater increases in mental fatigue, perceived effort, and sleepiness, and with reduced motivation and executive performance post-session; physical capacity is expected to show smaller decrements.

Students with sleep efficiency above 85% and nightly sleep duration above 7 hours will show greater resilience to mental fatigue, maintaining more stable reaction times and better cognitive performance than those with shorter or poorer-quality sleep.

Evening-type students will perform worse and feel sleepier during morning sessions compared with morning-type students, independently of total sleep duration, reflecting a chronotype × time-of-day interaction.

Mental fatigue will strongly impair cognitive tasks, while physical capacity (handgrip) will show relatively smaller declines.

Study design

The study uses a prospective, within-subject repeated-measures design with three main observation windows (T0, T1, T2).

Baseline/familiarization (T0):

A control week with no formal academic demands (no classes or exams). During this week, baseline psychometric, behavioral, and sleep profiles are collected, including overall sleep quality over the past 30 days and chronotype. Participants complete the Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ), provide demographic and lifestyle information (e.g., caffeine use, napping, fitness), and undergo baseline assessments of mental fatigue, sleepiness, motivation, cognitive performance, and handgrip strength and endurance.

Class condition (T1):

A regular theoretical lecture session is used as the exposure. Pre- and post-class assessments are conducted in both morning and afternoon sessions (ideally before 09:00 and after 13:00 for morning, before 14:00 and after 17:00 for afternoon). The same battery as at baseline is administered, with added measurement of class duration.

Exam condition (T2):

An exam session, when feasible based on each student's timetable, is used as a high-stakes exposure. Pre- and post-exam measures parallel those in the class condition. Exam grades are collected as an indicator of academic achievement.

Across all conditions, assessments are scheduled twice in the morning and twice in the afternoon, yielding multiple pre/post evaluations per participant.

Study population and eligibility

Participants are physiotherapy and psychology students at LUDES Institute. The target sample size is 30 students, with an expected dropout of 10-15% after the start of experimental procedures.

Inclusion criteria:

Enrolled physiotherapy or psychology student at LUDES Institute, age 18 years or older, no self-reported major neurological disorders or conditions that would impair cognitive or physical testing.

Exclusion criteria (relevant to the specific study sessions):

Use of psychostimulants (e.g., caffeine, energy drinks) before or during scheduled study sessions, vigorous exercise prior to testing sessions, melatonin intake, recent travel involving more than 3 time zones or shift/part-time shift work, self-reported clinical sleep disorders, absence from more than 25% of total scheduled lesson time.

Recruitment and informed consent

Recruitment and screening are coordinated by the project leader and the DIMUSCHEL research team. Students are initially informed about the study at the end of a class by a member of the research staff. Those who express interest receive more detailed information in person. After verbal agreement, students are given an information sheet and a consent form (pre-signed by the project leader and provided in duplicate). They are allowed sufficient time to read, ask questions, and decide whether to participate.

Participation is voluntary, and students may withdraw at any time without consequences. No financial compensation is offered. Signed consent forms are collected and retained as part of the study records.

Interventions and procedures

This is an observational study with no experimental therapeutic intervention. The "procedures" consist of non-invasive questionnaires, cognitive tasks, physical tests, and sleep monitoring.

Cognitive assessments

Stroop task (Encephalapp):

A tablet-based Stroop task is administered in two modes: congruent (Stroop "off") and incongruent (Stroop "on"). In the congruent condition, participants identify the color of pound signs displayed in different colors; in the incongruent condition, they identify the font color of color words presented in mismatched ink (e.g., the word "green" printed in blue). The test includes six phases per condition, with approximately 60 trials in each condition. Response time (latency for correct responses) and accuracy (number of correct responses) are recorded, and results are averaged across trials. Each Stroop assessment takes about 5 minutes.

Subjective states (mental fatigue, sleepiness, effort, motivation)

Visual Analogue Scale for Mental Fatigue (VAS-MF):

A 0-100 mm visual analogue scale anchored by "none at all" and "maximal" is used. Participants answer "How mentally fatigued do you feel now?" after receiving a standardized definition and examples of mental fatigue. Scores are derived by measuring the distance from the 0-mm anchor to the participant's mark.

Karolinska Sleepiness Scale (KSS):

A 9-point scale ranging from "not sleepy at all" to "extremely sleepy" is used to assess sleepiness. The KSS is administered before sleep, upon waking, and before and after teaching (T1) or exams (T2).

Rating of Perceived Exertion (CR-10 scale):

An 11-point numerical scale (0-10) assesses perceived effort during the handgrip endurance test. The scale is applied every 30 seconds, where 0 indicates no effort and 10 indicates maximal perceived exertion.

Motivational States Scale:

A 15-item Likert-type scale capturing task engagement, distress, and worry is administered before and after teaching and exam sessions.

Physical performance

Handgrip Strength and Endurance (HGSE):

Maximal and endurance handgrip performance is assessed using a hydraulic dynamometer. For maximal strength, participants perform three maximal squeezes with the dominant hand while seated, with the elbow at 90 degrees and wrist in a neutral position. Each squeeze lasts 3 seconds with 60 seconds rest, and the average of three trials is used for analysis. For endurance, participants maintain 40% of their own maximal force as long as possible; time to task failure is recorded, where failure is defined as force dropping below 40% for more than three seconds. The overall test (including setup, three maximal trials, and endurance bout) takes about 8 minutes.

Sleep and circadian assessment

Actigraphy and sleep diaries:

Sleep is monitored with wrist actigraphy (MotionWatch 8) and daily sleep diaries. During baseline and class conditions, actigraphy is recorded for two weeks, with an additional week for the exam condition when applicable. Sleep diary entries include bedtime, wake time, nap duration, and nocturnal awakenings. Derived parameters include bedtime, get-up time, time in bed, sleep onset and offset, sleep efficiency, sleep latency, wake after sleep onset, total sleep time, immobility time, and fragmentation index. Upon waking, participants rate sleep quality on a 10-point Likert scale. If actigraphy cannot be used for all participants, a "full diary plus actigraphy subsample" strategy is employed.

Questionnaires:

Sleep quality over the past month is assessed with the PSQI (Pittsburgh Sleep Quality Index), and chronotype with the MEQ (Morningness-Eveningness Questionnaire). These instruments inform the analysis of how sleep history and circadian preference influence acute responses to classes and exams.

Assessment sequence and duration

To reduce carry-over and arousal effects, the assessment sequence at each session is fixed: VAS-MF (Visual Analogue Scale for Mental Fatigue), KSS (Karolinska Sleepiness Scale), Stroop task, Motivation (Motivational States Scale), Handgrip endurance with perceived effort.

This sequence ensures that subjective state ratings are collected before tasks that could alter them, that vigilance tasks precede more complex executive tasks, and that physical exertion is last to avoid sympathetic activation affecting cognitive measures. Total time per assessment session is approximately 20 minutes.

Outcomes

Primary outcome

Within-subject change in mental fatigue (VAS-MF; 0-100 mm) and cognitive performance (Stroop reaction time/accuracy) from pre- to post-session across baseline, class, and exam conditions.

Key secondary outcomes

Sleep and circadian metrics (actigraphy + diaries, KSS, PSQI, MEQ), Handgrip strength and endurance (including perceived exertion), Motivation (Motivational States Scale scores), Academic performance (exam grades), Perceived stress components and time-of-day effects.

Sample size and statistical analysis

An a priori power analysis using a repeated-measures framework indicated that 26 participants would provide approximately 81% power (alpha 0.05) to detect the expected interaction on mental fatigue (Time × Turn; pre/post × morning/afternoon). Allowing for about 10% attrition, 30 participants will be recruited.

Primary analyses will use mixed-effects models with students as random intercepts. Fixed effects will include Session (pre vs post), Condition (T0/T1/T2), Time of day (AM vs PM), class/exam duration, and sleep/circadian covariates (e.g., prior-night total sleep time, sleep efficiency, sleep latency, MEQ score), as well as interaction terms (e.g., Session × Duration, Session × Time of day, Session × MEQ). The models will estimate how academic load and timing, combined with sleep and chronotype, influence changes in psychobiological outcomes.

Missing data will be addressed by recruiting additional participants if necessary to maintain adequate power, and by using mixed-model approaches that can accommodate incomplete repeated measures.

Safety, risk, and ethics

The study involves only minimal risk procedures (questionnaires, non-invasive cognitive tasks, handgrip testing, and actigraphy). No drugs, devices, or radiation are used. The project is classified as Category A and adheres to the Declaration of Helsinki, ICH-GCP (International Council for Harmonisation Good Clinical Practice), and Swiss regulations.

Participation is voluntary, and withdrawal is allowed at any time. If participants withdraw after contributing data, their existing data may still be used in analyses in pseudonymized form, unless they request otherwise in line with applicable law.

Data management, confidentiality, and quality assurance

Data are captured in case report forms and electronic databases using unique participant codes. The key linking codes to identities is stored separately under restricted access, solely for purposes of follow-up assessments and longitudinal linkage. After the end of the study, data may be fully anonymized when feasible, and will be stored and destroyed according to institutional and legal requirements.

Confidentiality is safeguarded through coding, secure storage, and controlled access. Only authorized study staff will access identifiable information. Quality assurance measures include standardized training of assessors, fixed testing sequences, and use of validated instruments to ensure reliability and internal validity.

Keywords
sleep, mental fatigue, performance, learning
Medical subject headings
Mental Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07644611
Study groupRoleWhat they receive
Baseline T0Students assessed during a control week without formal classes or exams.
Teaching Session (T1)Same students assessed immediately before and after a regular theoretical class (morning and afternoon sessions).
Exam Session (T2)Subset of students assessed immediately before and after an exam session scheduled in their curriculum (morning or afternoon)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective mental fatigue

    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.

    Measured: 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.

  2. Cognitive performance

    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.

    Measured: 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.

Secondary outcomes (11)
  1. Sleepiness

    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.

    Measured: 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).

  2. Motivation

    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).

    Measured: Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.

  3. Physical performance: handgrip strength

    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.

    Measured: Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.

  4. Physical performance: handgrip endurance

    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.

    Measured: Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.

  5. Perceived exertion

    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.

    Measured: During each handgrip endurance test (pre- and post-session) at baseline (T0), teaching (T1), and exam (T2) sessions.

  6. Bedtime, wake time, time in bed, sleep onset, and sleep offset

    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).

    Measured: 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.

  7. Sleep efficiency and fragmentation index

    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 (%).

    Measured: 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.

  8. Sleep latency, wake after sleep onset, total sleep time, immobility time, naps, and nocturnal awakenings

    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).

    Measured: 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.

  9. Chronotype

    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).

    Measured: At the week in which occurs the baseline (T0).

  10. Sleep quality

    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.

    Measured: At baseline (T0) referring to the previous month.

  11. Academic achievement

    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.

    Measured: At the exam (T2) session.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2026
  2. Study start1 Jul 2026
  3. Primary completion20 Dec 2026 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case crossover
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07644611
Sponsor's protocol ID
RE-2026-02
Other IDs
IZSEZ0_241118/1
Status last verified
Sep 2026
First submitted
2 Jun 2026
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data underlying the published results (e.g., psychometric and actigraphy variables) may be shared with qualified researchers upon reasonable request to the principal investigator, after ethics approval and data-sharing agreement. Data will be available beginning 12 months after main publication, for up to 5 years, for analyses related to sleep, fatigue, and academic performance.

Publications

  • Rivkin, S. G., & Schiman, J. C. (2015). Instruction time, classroom quality, and academic achievement. The Economic Journal, 125(588), F425-F448.

  • Lee KA, Hicks G, Nino-Murcia G. Validity and reliability of a scale to assess fatigue. Psychiatry Res. 1991 Mar;36(3):291-8. doi: 10.1016/0165-1781(91)90027-m.

    PubMed 2062970
  • Van Cutsem J, Marcora S, De Pauw K, Bailey S, Meeusen R, Roelands B. The Effects of Mental Fatigue on Physical Performance: A Systematic Review. Sports Med. 2017 Aug;47(8):1569-1588. doi: 10.1007/s40279-016-0672-0.

    PubMed 28044281
  • Soylu Y, Arslan E, Akcay N, Akgul MS, Kilit B, Lopes TR, de Lima-Junior D. Effects of mental fatigue on psychophysiological responses, kinematic variables and technical actions in small-sided soccer games: a time course analysis. Front Psychol. 2025 Oct 2;16:1654701. doi: 10.3389/fpsyg.2025.1654701. eCollection 2025.

    PubMed 41112567
  • Solon-Junior LJF, Vieira da Silva Neto L, Lima-Junior D, Costa YP, Klinger da Silva Oliveira J, Fiorese L, Fortes LS. "Encephalapp Stroop": Validity and reliability of a smartphone app to measure cognitive performance in physically active subjects. Appl Neuropsychol Adult. 2026 Jan-Feb;33(1):219-224. doi: 10.1080/23279095.2024.2343024. Epub 2024 Apr 15.

    PubMed 38621290
  • Smith, A. (2018). Cognitive fatigue and the wellbeing and academic attainment of university students. Journal of Education, Society and Behavioural Science.

  • Plukaard, S., Huizinga, M., Krabbendam, L., & Jolles, J. (2015). Cognitive flexibility in healthy students is affected by fatigue: An experimental study. Learning and Individual Differences, 38, 18-25.

  • Matthews G, Campbell SE, Falconer S, Joyner LA, Huggins J, Gilliland K, Grier R, Warm JS. Fundamental dimensions of subjective state in performance settings: task engagement, distress, and worry. Emotion. 2002 Dec;2(4):315-40. doi: 10.1037/1528-3542.2.4.315.

    PubMed 12899368
  • de Lima-Junior, D., Gantois, P., Nakamura, F. Y., Marcora, S. M., Batista, G. R., Bartolomei, S., ... & de Sousa Fortes, L. (2024). Mental fatigue impairs the number of repetitions to muscular failure in the half back-squat exercise for low-and mid-but not high-intensity resistance exercise. European Journal of Sport Science, 24(4), 395-404.

  • de Lima-Junior D, Caporaso G, Cortesi M, Fortes LS, Marcora SM. Effects of mental fatigue on perception of effort and performance in national level swimmers. Front Psychol. 2025 Apr 9;16:1520156. doi: 10.3389/fpsyg.2025.1520156. eCollection 2025.

    PubMed 40271358
  • Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97-110.

    PubMed 1027738
  • Hobson JA, Pace-Schott EF. The cognitive neuroscience of sleep: neuronal systems, consciousness and learning. Nat Rev Neurosci. 2002 Sep;3(9):679-93. doi: 10.1038/nrn915.

    PubMed 12209117
  • Filipas L, Ferioli D, Banfi G, La Torre A, Vitale JA. Single and Combined Effect of Acute Sleep Restriction and Mental Fatigue on Basketball Free-Throw Performance. Int J Sports Physiol Perform. 2021 Mar 1;16(3):415-420. doi: 10.1123/ijspp.2020-0142. Epub 2021 Jan 12.

    PubMed 33440343
  • Diette, T. M., & Raghav, M. (2017). Does early bird catch the worm or a lower GPA? Evidence from a liberal arts college. Applied Economics, 49(33), 3341-3350.

  • Dietch JR, Taylor DJ. Evaluation of the Consensus Sleep Diary in a community sample: comparison with single-channel electroencephalography, actigraphy, and retrospective questionnaire. J Clin Sleep Med. 2021 Jul 1;17(7):1389-1399. doi: 10.5664/jcsm.9200.

    PubMed 33666165

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Fatigue and Sleep and Circadian Problems, run by L.U.de.S. Sagl at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jacopo A Vitale, Ph.D. (+41 799252830, Jacopo.VITALE@uniludes.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective mental fatigue (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07644611, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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