Sleep, Mental Fatigue, and Performance in Students

NCT07644611 | Not Yet Recruiting

• 2 other identifiers: RE-2026-02IZSEZ0_241118/1
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

T0 - Baseline/Control; T1 - Teaching Days; T2 - Exam Days

Keywords

sleep; mental fatigue; performance; learning

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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.

Secondary Outcomes (11)

• 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

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

• Physical performance: handgrip strength

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

• Physical performance: handgrip endurance

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

• Perceived exertion

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

Study Arms (3)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• L.U.de.S. Sagl: lead

Study Sites (1)

LUDES - Istituto Universitario Professionale

Lugano, Canton Ticino, 6912, Switzerland

Location

Related Publications (23)

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MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Central Study Contacts

Jacopo A Vitale, Ph.D.

CONTACT

+41 799252830; Jacopo.VITALE@uniludes.ch

Dalton de Lima Junior, Ph.D.

CONTACT

dalton.delima@uniludes.ch

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)