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Sleep, Mental Fatigue, and Performance in Students

8 czerwca 2026 zaktualizowane przez: Jacopo Vitale, L.U.de.S. Sagl

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

30

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

    • Canton Ticino
      • Lugano, Canton Ticino, Szwajcaria, 6912
        • LUDES - Istituto Universitario Professionale
        • Kontakt:

Kryteria uczestnictwa

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Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Baseline T0
Students 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)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Subjective mental fatigue
Ramy czasowe: 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.
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.
Cognitive performance
Ramy czasowe: 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.
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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Sleepiness
Ramy czasowe: 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.
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).
Motivation
Ramy czasowe: 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).
Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.
Physical performance: handgrip strength
Ramy czasowe: 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.
Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.
Physical performance: handgrip endurance
Ramy czasowe: 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.
Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.
Perceived exertion
Ramy czasowe: 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.
During each handgrip endurance test (pre- and post-session) at baseline (T0), teaching (T1), and exam (T2) sessions.
Bedtime, wake time, time in bed, sleep onset, and sleep offset
Ramy czasowe: 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).
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.
Sleep efficiency and fragmentation index
Ramy czasowe: 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 (%).
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.
Sleep latency, wake after sleep onset, total sleep time, immobility time, naps, and nocturnal awakenings
Ramy czasowe: 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).
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.
Chronotype
Ramy czasowe: 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).
At the week in which occurs the baseline (T0).
Sleep quality
Ramy czasowe: 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.
At baseline (T0) referring to the previous month.
Academic achievement
Ramy czasowe: 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.
At the exam (T2) session.

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Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 lipca 2026

Zakończenie podstawowe (Szacowany)

20 grudnia 2026

Ukończenie studiów (Szacowany)

20 lutego 2027

Daty rejestracji na studia

Pierwszy przesłany

2 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

12 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

12 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

8 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • RE-2026-02
  • IZSEZ0_241118/1 (Inny numer grantu/finansowania: Swiss National Science Foundation (SNSF))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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