The Individual Response of Healthy Individuals to Mental Fatigue
NCT05576935, Not applicable, Completed, Vrije Universiteit Brussel
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | The Individual Response of Healthy Individuals to Mental Fatigue | ClinicalTrials.gov |
| NCT number | NCT05576935 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 142 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Vrije Universiteit Brussel | ClinicalTrials.gov |
| Conditions | Mental Fatigue | ClinicalTrials.gov |
| Interventions | Stroop task, Documentary | ClinicalTrials.gov |
| First posted | 2022-10-13 | ClinicalTrials.gov |
| Last updated | 2024-08-28 | ClinicalTrials.gov |
Registered outcomes 37
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Physical performance | through study completion, an average of 2 years | Participants will perform a time trial to assess physical performance. Participants will be able to start a 3 min fixed intensity warm-up. The trial itself lasts 15 min and participants are instructed to cover as much distance as possible. To keep the influence of motivation to a minimum, no encouragements or performance feedback will be given during the trial. The participants will only see the amount of time they have left on a digital chronometer. After the trial, a 2 min self-paced cooldown period will start. The evaluted outcome will be total workload performed by the participants (in kJ). | ClinicalTrials.gov |
| Primary | Cognitive performance: Go NoGo task: attention | through study completion, an average of 2 years | Cognitive performance will be assessed using a task based on the go/no-go paradigm. Participants are to react to different stimuli displayed on a computer screen positioned about 1 meter from the subject, preceded by a screen with general instructions. Two different stimuli were present at the same time: a Go or NoGo stimuli, and a left or right stimuli (meaning that four combinations are possible: GoRight, GoLeft, NoGoRight and NoGoLeft). If a Go stimuli is presented, participants are instructed to react to the left or right stimuli with the corresponding arrows. However, if a NoGo stimulus is presented, participants are instructed to refrain from reacting to the either the left or right stimuli. This proposed paradigm measures attention, response inhibition and working memory. Stimuli will be presented for 500 ms, with a varying interstimulus time between 1100 and 1700 ms. Outcome for attention will be reaction time on the Go trials. | ClinicalTrials.gov |
| Primary | Cognitive performance: Go NoGo task: response inhibition | through study completion, an average of 2 years | Cognitive performance will be assessed using a task based on the go/no-go paradigm. Participants are to react to different stimuli displayed on a computer screen positioned about 1 meter from the subject, preceded by a screen with general instructions. Two different stimuli were present at the same time: a Go or NoGo stimuli, and a left or right stimuli (meaning that four combinations are possible: GoRight, GoLeft, NoGoRight and NoGoLeft). If a Go stimuli is presented, participants are instructed to react to the left or right stimuli with the corresponding arrows. However, if a NoGo stimulus is presented, participants are instructed to refrain from reacting to the either the left or right stimuli. This proposed paradigm measures attention, response inhibition and working memory. Stimuli will be presented for 500 ms, with a varying interstimulus time between 1100 and 1700 ms. Outcome for response inhibition will be accuracy on the NoGo trials. | ClinicalTrials.gov |
| Secondary | Subjective Manipulation check: M-VAS | through study completion, an average of 2 years | The M-VAS-scale (0-10cm) will be taken at multiple different time points (i.e. at the start of the trial, after the EEG baseline, after the pre cognitive performance task, after the behavioural manipulation check, during the intervention/control task, after the post behavioural manipulation check, after the post cognitive performance outcome and after the physical task). It will assess how mentally fatigued the subject is feeling (100 point VAS scale), and ranges from 'not at all' to 'completely exhausted'. The validity and reliability of a visual analogue scale to assess general fatigue was demonstrated by Lee et al., and this type of scale has been shown to be one of the most sensitive assessments of MF. | ClinicalTrials.gov |
| Secondary | Behavioural Manipulation check: Stroop reaction time | through study completion, an average of 2 years | Reaction time on the stroop will be assessed to determine behavioural induction of mental fatigue. | ClinicalTrials.gov |
| Secondary | Behavioural Manipulation check: Stroop accuracy | through study completion, an average of 2 years | Accuracy on the stroop will be assessed to determine behavioural induction of mental fatigue. | ClinicalTrials.gov |
| Secondary | Physiological manipulation check - EEG (theta and alpha power and ERPs) | through study completion, an average of 2 years | Electroencephalography (EEG) will be used to continuously measure brain activity by using 32 active Ag/AgCl electrodes attached on the participants' head (Acticap, Brain Products Munich, Germany), according to the "10:20 International System". The sampling rate will be set at 500 Hz (Brain Vision Recorder, Brain Products, Munich, Germany). Electrode impedance will be kept \<10 kΩ throughout the recording. Baseline measurements will be taken 2 min with eyes open, 2 min with eyes closed and subjects will be seated in a sound isolated dimly lit room. Afterwards, Event-related potentials (ERP), spectral power and brain connectivity analysis will be executed. The aim of the EEG device is to measure the presence of MF during the Stroop task, and to identify possible mechanisms behind the suspected decreases in human performance. | ClinicalTrials.gov |
| Secondary | Age | through study completion, an average of 2 years | Age will be assessed to determine influences on mental fatigue effects | ClinicalTrials.gov |
| Secondary | Length | through study completion, an average of 2 years | Length will be assessed to determine influences on mental fatigue effects (using SECA 206, SECA Benelux, The Netherlands) | ClinicalTrials.gov |
| Secondary | Weight | through study completion, an average of 2 years | Weight will be assessed to determine influences on mental fatigue effects (using Tanita TBF 300, Tanita Europe BV, The Netherlands) | ClinicalTrials.gov |
| Secondary | Sex | through study completion, an average of 2 years | Sex will be assessed to determine influences on mental fatigue effects | ClinicalTrials.gov |
| Secondary | Fat percentage | through study completion, an average of 2 years | Fat percentage will be assessed to determine influences on mental fatigue effects (Tanita TBF 300, Tanita Europe BV, The Netherlands) | ClinicalTrials.gov |
| Secondary | Burn out | through study completion, an average of 2 years | General health will be assessed using the Burn out assessment tool (BAT). The questionnaire assesses 4 core domains in burn out: exhaustion, emotional impairment, cognitive impairment and mental distance Moreover, 2 additional domains that assess specific symptoms of burn out are also assessed: psychosomatic complaints and psychological distress. | ClinicalTrials.gov |
| Secondary | Recovery need | through study completion, an average of 2 years | Additionally, a questionnaire that determines recovery need will be added to the burn out assessment. For this part, we will use the recovery need section of the "Short Inventory to Monitor Psychosocial Hazards" questionnaire. | ClinicalTrials.gov |
| Secondary | Physical training level (objective) | through study completion, an average of 2 years | Objectively, a graded maximal cycle ergometer test will be performed in 18-20°C and a RH of 40%, to attain the maximal exercise ability. This ability will then be translated to a specific performance level as defined by De Pauw et al. | ClinicalTrials.gov |
| Secondary | Physical training level (subjective) | through study completion, an average of 2 years | Subjectively, the international physical activity questionnaire short form (IPAQ-SF) will assess the overall physical activity habits of the participant. The IPAQ-SF consists of 7 questions, assessing amount and level of intensity of physical activity in the last 7 days, and represents good reliability and validity. | ClinicalTrials.gov |
| Secondary | Sport participation | through study completion, an average of 2 years | a specific questionnaire will be designed with questions examining sport participation. These answers on these questions will then be employed to divide participants into a tier based system as proposed by McKay et al. | ClinicalTrials.gov |
| Secondary | Working memory | through study completion, an average of 2 years | Working memory will be assessed using a short n-back task. Participants will be instructed to focus on a white computer screen with a randomly generated number between 0-9. They have to press a button if the number in front of them matches the number they encountered 2 numbers earlier (2 back paradigm). Stimuli are presented for 500 ms, with an interstimulus time of 2500 ms, and a target/non target ratio of 33/67 (58). Outcomes include ACC (percentage of correct responses). | ClinicalTrials.gov |
| Secondary | Response inhibition | through study completion, an average of 2 years | To examine response inhibition, participants will be required to perform a sustained attention to response task (SART). Participants were presented with single digits in the centre of the screen, ranging from 0-9, and were instructed to react as fast as possible if a number was shown on screen. However, if the number that was displayed equalled 3, participants were asked to refrain from responding. To specifically measure response inhibition, the outcome of this task consisted of the percentage of correct responses to the number 3 stimulus. | ClinicalTrials.gov |
| Secondary | Attention | through study completion, an average of 2 years | Attention will be assessed using a psychomotor vigilance task (PVT). The task features a red triangle in the centre of a computer screen, where participants are required to react as fast as possible when a yellow count is started in the middle of this red triangle. The interstimulus time ranges between 2 and 10 sec. Mean RT is collected as outcome, and false alarms (\>200 ms reaction) and misses (\>900 ms) are also measured. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 7
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Primary outcome | ConductCognition |
| 1-Back Task | Secondary outcome | ConductCognition |
| 2-Back Task | Secondary outcome | ConductCognition |
| Psychomotor Vigilance Task | Secondary outcome | ConductCognition |
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Sustained Attention to Response | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)