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Recruiting NCT07323810

Monitoring the Effect of Mental Fatigue on Physical Performance Using Wearable Sensors and Physiological Parameters

No phase Interventional Mental Fatigue

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mental Fatigue.
Who it may be relevant to
Registry conditions: Mental Fatigue. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Mental fatigue (MF) negatively affects both cognitive and physical performance, increasing the risk of errors in high-stakes environments such as sports and surgery. Traditional methods to assess MF rely on subjective self-report scales, which are prone to bias, or on complex brain measurements (e.g. EEG) that are impractical outside laboratory settings. This study aims to develop a real-time, objective monitoring method for MF using wearable physiological sensors. The study will recruit healthy, trained runners (18-35 years old) who will complete both an MF-inducing cognitive task (Stroop test) and a control condition (watching a documentary) in a randomized, counterbalanced, crossover design. Heart rate variability, respiration rate, and pupil metrics will be continuously recorded using wearable devices. Machine learning models will be used to predict MF-level as well as the effect of MF on physical performance (5-km time trial on a treadmill) using the physiological data as input.

Interventions

  • Behavioral Mental Fatigue
    Mental fatigue (MF) is a psychobiological state characterized by feelings of tiredness and/or a measurable decline in performance following prolonged or intense cognitive activity.

Primary outcome measures

  • Heart rate variability time-domain parameters [Time frame: Continuously during the cognitive intervention and control condition on the study day (approximately 75 minutes).]
  • Heart rate variability frequency-domain parameters [Time frame: Continuously during the cognitive intervention and control condition on the study day (approximately 75 minutes).]
  • Respiration rate [Time frame: Continuously during the cognitive intervention and control condition on the study day (approximately 75 minutes).]
  • Pupil diameter [Time frame: Continuously during the cognitive intervention and control condition on the study day (approximately 75 minutes).]
  • Blinking rate [Time frame: Continuously during the cognitive intervention and control condition on the study day (approximately 75 minutes).]
  • Eyelid opening [Time frame: Continuously during the cognitive intervention and control condition on the study day (approximately 75 minutes).]
  • Cognitive Performance Accuracy [Time frame: At baseline (pre-intervention), during the 60-minute cognitive intervention, and immediately after completion of the intervention on the study day (approximately 70 minutes total).]
  • Cognitive Performance Reaction Time [Time frame: At baseline (pre-intervention), during the 60-minute cognitive intervention, and immediately after completion of the intervention on the study day (approximately 70 minutes total).]
  • Physical performance: Time to Completion [Time frame: Immediately after completion of the 60-minute cognitive intervention, during a single 5-km treadmill time trial on the study day (approximately 20 minutes).]
Secondary outcome measures (7)
  • Subjective feeling of Mental Fatigue [Time frame: At baseline (pre-intervention), every 5 minutes during the 60-minute cognitive intervention, and immediately after completion of the intervention on the study day.]
  • Mood [Time frame: At baseline, prior to the start of each experimental and control trial on the study day.]
  • Motivation [Time frame: At baseline (pre-intervention) and immediately after completion of the 60-minute cognitive intervention on the study day.]
  • Sleepiness [Time frame: At baseline (pre-intervention) and immediately after completion of the 60-minute cognitive intervention on the study day.]
  • Physical fatigue [Time frame: Immediately prior to the physical performance test on the study day.]
  • Perceived physical exertion [Time frame: During the 5-km treadmill time trial, assessed at the end of each kilometer on the study day.]
  • Pacing [Time frame: During the 5-km treadmill time trial, assessed at the end of each kilometer on the study day.]

Eligibility criteria

Inclusion criteria

  • Healthy (no neurological, cardiovascular or musculoskeletal disorders of any kind)
  • Male or female
  • No prior knowledge of the concept of MF
  • No medication
  • Non-smoker
  • 18-35 years of age
  • Experienced runners: (≥15km/week and/or ≥2u/week during the last 6 months)

Exclusion criteria

  • Injuries in the past 6 months, affecting running performance
  • Suffering from a chronic health condition (could be neurological, cardiovascular, internal or musculoskeletal)
  • Participating in any concomitant care or research trials
  • History of suffering from any mental/psychiatric disorders
  • Use of medication
  • Use of caffeine and heavy efforts 24 hours prior each trial
  • Suffering from colour vision deficiencies
  • Not eating a standardized meal, the morning of each trial and the evening before each trial

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Belgium · 1 center
  • Brussels Labo voor Inspanning en Topsport — Brussels

Identifiers

NCT: NCT07323810 · EC-2025-113

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗