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Идёт набор NCT07323810

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

Без фазы С лечением Mental Fatigue

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mental Fatigue.
Кому может быть актуально
Состояния в реестре: Mental Fatigue. Базовые параметры: 18 лет — 35 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Бельгия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

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.

Вмешательства

  • Поведенческое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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)

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Бельгия · 1 центр
  • Brussels Labo voor Inspanning en Topsport — Brussels

Идентификаторы

NCT: NCT07323810 · EC-2025-113

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗