Sleep, Mental Fatigue, and Performance in Students
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorL.U.de.S. Sagl
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
30 Participants
are grouped into 3 trial groupsGroup A: Baseline T0
Group B: Teaching Session (T1)
Group C: Exam Session (T2)
Trial outcomes
Primary outcomes
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.
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.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.
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.Secondary outcomes
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.
Time frame
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).
Time frame
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.
Time frame
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.
Time frame
Pre- and post-session during each baseline (T0), teaching (T1), and exam (T2) assessment.Sponsors and contacts
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Source ClinicalTrials.gov