CognitionSAPIENSNCT07087236
Sedentary Activities and Passive-to-Intense Effects on Neuro-Cognitive States
A study testing Maximum Cognitive Load, Mental active/pasive activities and Baseline Cognitive Load in people with Cognition and Sedentary Behaviors, run by Pontificia Universidad Catolica de Valparaiso at 1 site in Chile.
Trial summary
Prolonged sedentary behavior is linked to poorer metabolic health, yet its effect on cognitive load and brain function remains unclear. Evidence indicates that "mentally active" sedentary tasks (e.g., reading) may support cognition, whereas "mentally passive" tasks (e.g., scrolling social media) may impair it. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition, Sedentary Behaviors
- What is being tested?
- Maximum Cognitive Load, Mental active/pasive activities and Baseline Cognitive Load
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Children aged 5 to 17 years, attending school.
- Adults aged 18 and above, without an upper age limit.
- Participants with and without specific health conditions, such as obesity.
- Ability to perform sedentary activities and comprehend instructions.
Who cannot join
- Severe visual impairments affecting reading or text visualization.
- Use of conventional glasses and history of migraine or epilepsy (due to preventive request for the flicker fusion test)
- Current use of medications that significantly influence cognitive function (unless the health condition being evaluated requires it).
- Other conditions interfering with cognitive or neurophysiological assessments.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Prolonged sedentary behavior is linked to poorer metabolic health, yet its effect on cognitive load and brain function remains unclear. Evidence indicates that "mentally active" sedentary tasks (e.g., reading) may support cognition, whereas "mentally passive" tasks (e.g., scrolling social media) may impair it. The cognitive demands associated with these behaviors across the general population are still poorly defined. This project will compare the acute neurophysiological and perceptual responses elicited by mentally active versus passive sedentary tasks across various age groups and in individuals with specific health conditions (i.e., obesity), clarifying how these behaviors differ in the cognitive load they impose. Neuro-cognitive, physiological, and perceptual responses will be assessed with a multimodal battery that includes portable electroencephalography combined with functional near-infrared spectroscopy (EEG + fNIRS; MUSE), eye-tracking (Pupil Core), alertness and visual fatigue via critical flicker fusion testing (CFFT; Lafayette Instrument), autonomic balance through heart-rate variability (HRV) recorded with a Polar H10 monitor, and the self-reported cognitive load assessed using the NASA Task Load Index (NASA-TLX). We hypothesise that mentally passive sedentary activities will elicit a lower cognitive load than mentally active tasks. By comparing different age groups and health conditions within a single protocol, the study will generate an initial set of group-specific data; subsequent independent studies can build on these findings to explore moderation effects in greater depth. Collectively, the results will provide both the theoretical rationale and the empirical evidence needed to sustain the "mentally active" versus "mentally passive" terminology in sedentary-behaviour research, with the ultimate aim of improving mental and cognitive health.
- Conditions
- Cognition, Sedentary Behaviors
- Being tested
- Maximum Cognitive Load, Mental active/pasive activities, Baseline Cognitive Load
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximum Cognitive LoadBehavioural
Participants will perform a working memory task (through N-back 1-to-3) to evaluate the upper limit of cognitive demand.
Mental active/pasive activitiesBehavioural
Participants will engage in 7 activities, presented in a randomly assigned order across two separate days, to assess their impact on cognitive load:
- playing a videogame (Tetris ®)
- listening a podcast (including a final question)
- watching a documentary (including a final question)
- reading a document extract (including a final question)
- watch a reality show extract (including a final question)
- listening music, they like it
- scrolling their Tik-Tok/Instagram
Baseline Cognitive LoadBehavioural
Participants will sit quietly for 5 minutes to establish baseline spontaneous neurophysiological parameters.
| Study group | Role | What they receive |
|---|---|---|
| Baseline Cognitive Condition | Active comparator | Not described Receives: Behavioral: Baseline Cognitive Load |
| Maximum Cognitive Load Condition | Active comparator | Not described Receives: Behavioral: Maximum Cognitive Load |
| Experimental Mentally Active and Mentally Passive Sedentary Activities | Experimental | Not described Receives: Behavioral: Mental active/pasive activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography-derived cortical activity (EEG)
This outcome will be evaluated using a portable EEG system (MUSE Athena), which will evaluate four types of brain waves-alpha (8-12 Hz), gamma (31-90 Hz), theta (4-7 Hz), and beta (13-30 Hz)-along with two wave ratios: theta/alpha and beta/alpha.
Measured: Day 1 and 2
Hemodynamic Response (fNIRS)
This outcome will be evaluated using a portable functional near-infrared spectroscopy system (fNIRS) in the MUSE headband, assessing changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) concentrations in the prefrontal cortex.
Measured: Day 1 and 2
Eye-Tracking Metrics
This outcome will be evaluated using a validated portable eye tracker (Pupil Core) to assess eye metrics.
Measured: Day 1 and 2
Heart Rate Variability (HRV)
This outcome will be evaluated using a chest strap device connected wirelessly to a tablet (Polar H10). Changes in HRV and heart rate are analyzed as a physiological marker (autonomic balance).
Measured: Day 1 and 2
Critical Flicker Fusion Threshold (Flicker Fusion)
This outcome will be evaluated using the Flicker Fusion System (Lafayette Instrument Company) with the "coincident" stimulus to determine the critical flicker fusion threshold (Hz).
Measured: Day 1 and 2
Self-Reported Cognitive Load (NASA-TLX)
The Self-Reported Cognitive Load is measured using the NASA Task Load Index (NASA-TLX). Scores range from 0 to 100, with higher scores indicating greater cognitive load. Capturing subjective workload across six dimensions: mental demand, physical demand, temporal demand, effort, performance, and frustration.
Measured: day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This intra-individual study will be conducted in three separate days. The first day will be performed the "familiarization day" for those being evaluated, assessing basal (through spontaneous sitting activity) and maximal (through N-back test) cognitive load and additionally, the evaluators will conducted physical measures (e.g., body composition through DEXA, fitness by the 3-minute step and strength using dynamometer (Jamar Plus + Digital Hand Dynamometer, Sammons Preston, USA), and sociodemographic questionnaire. The second day, the evaluators will conduct four randomized activities. Finally, the third day, the evaluators will conduct the final 3 activities, which also will be randomized between mentally passive and active activities.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Valparaiso
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Cristi Montero, Pontificia Universidad Catolica de Valparaiso
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087236
- Sponsor's protocol ID
- BIOEPUCV-H 858-2024
- Acronym
- SAPIENS
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2025
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Activities and Passive-to-Intense Effects on Neuro-Cognitive States
- ClinicalTrials.gov ID
- NCT07087236
- Acronym / sponsor ID
- SAPIENS / BIOEPUCV-H 858-2024
- Conditions
- Cognition, Sedentary Behaviors
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ValparaisoUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged sedentary behavior is linked to poorer metabolic health, yet its effect on cognitive load and brain function remains unclear. Evidence indicates that "mentally active" sedentary tasks (e.g., reading) may support cognition, whereas "mentally passive" tasks (e.g., scrolling social media) may impair it. The cognitive demands associated with these behaviors across the general population are still poorly defined. This project will compare the acute neurophysiological and perceptual responses elicited by mentally active versus passive sedentary tasks across various age groups and in individuals with specific health conditions (i.e., obesity), clarifying how these behaviors differ in the cognitive load they impose. Neuro-cognitive, physiological, and perceptual responses will be assessed with a multimodal battery that includes portable electroencephalography combined with functional near-infrared spectroscopy (EEG + fNIRS; MUSE), eye-tracking (Pupil Core), alertness and visual fatigue via critical flicker fusion testing (CFFT; Lafayette Instrument), autonomic balance through heart-rate variability (HRV) recorded with a Polar H10 monitor, and the self-reported cognitive load assessed using the NASA Task Load Index (NASA-TLX). We hypothesise that mentally passive sedentary activities will elicit a lower cognitive load than mentally active tasks. By comparing different age groups and health conditions within a single protocol, the study will generate an initial set of group-specific data; subsequent independent studies can build on these findings to explore moderation effects in greater depth. Collectively, the results will provide both the theoretical rationale and the empirical evidence needed to sustain the "mentally active" versus "mentally passive" terminology in sedentary-behaviour research, with the ultimate aim of improving mental and cognitive health.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This intra-individual study will be conducted in three separate days. The first day will be performed the "familiarization day" for those being evaluated, assessing basal (through spontaneous sitting activity) and maximal (through N-back test) cognitive load and additionally, the evaluators will conducted physical measures (e.g., body composition through DEXA, fitness by the 3-minute step and strength using dynamometer (Jamar Plus + Digital Hand Dynamometer, Sammons Preston, USA), and sociodemographic questionnaire. The second day, the evaluators will conduct four randomized activities. Finally, the third day, the evaluators will conduct the final 3 activities, which also will be randomized between mentally passive and active activities.
| Arm | Type | Receives |
|---|---|---|
| Baseline Cognitive Condition | Active comparator | Behavioral: Baseline Cognitive Load |
| Maximum Cognitive Load Condition | Active comparator | Behavioral: Maximum Cognitive Load |
| Experimental Mentally Active and Mentally Passive Sedentary Activities | Experimental | Behavioral: Mental active/pasive activities |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children aged 5 to 17 years, attending school.
- Adults aged 18 and above, without an upper age limit.
- Participants with and without specific health conditions, such as obesity.
- Ability to perform sedentary activities and comprehend instructions.
Key exclusion criteria (4 listed)
- Severe visual impairments affecting reading or text visualization.
- Use of conventional glasses and history of migraine or epilepsy (due to preventive request for the flicker fusion test)
- Current use of medications that significantly influence cognitive function (unless the health condition being evaluated requires it).
- Other conditions interfering with cognitive or neurophysiological assessments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximum Cognitive LoadParticipants will perform a working memory task (through N-back 1-to-3) to evaluate the upper limit of cognitive demand. | Behavioural | Maximum Cognitive Load Condition |
| Mental active/pasive activitiesParticipants will engage in 7 activities, presented in a randomly assigned order across two separate days, to assess their impact on cognitive load: 1. playing a videogame (Tetris ®) 2. listening a podcast (including a final question) 3. watching a documentary (including a final question) 4. reading a document extract (including a final question) 5. watch a reality show extract (including a final question) 6. listening music, they like it 7. scrolling their Tik-Tok/Instagram | Behavioural | Experimental Mentally Active and Mentally Passive Sedentary Activities |
| Baseline Cognitive LoadParticipants will sit quietly for 5 minutes to establish baseline spontaneous neurophysiological parameters. | Behavioural | Baseline Cognitive Condition |
Primary outcome
Electroencephalography-derived cortical activity (EEG)
Time frame: Day 1 and 2
This outcome will be evaluated using a portable EEG system (MUSE Athena), which will evaluate four types of brain waves-alpha (8-12 Hz), gamma (31-90 Hz), theta (4-7 Hz), and beta (13-30 Hz)-along with two wave ratios: theta/alpha and beta/alpha.
Hemodynamic Response (fNIRS)
Time frame: Day 1 and 2
This outcome will be evaluated using a portable functional near-infrared spectroscopy system (fNIRS) in the MUSE headband, assessing changes in oxyhemoglobin (HbO) and deoxyhemoglobin (HbR) concentrations in the prefrontal cortex.
Eye-Tracking Metrics
Time frame: Day 1 and 2
This outcome will be evaluated using a validated portable eye tracker (Pupil Core) to assess eye metrics.
Heart Rate Variability (HRV)
Time frame: Day 1 and 2
This outcome will be evaluated using a chest strap device connected wirelessly to a tablet (Polar H10). Changes in HRV and heart rate are analyzed as a physiological marker (autonomic balance).
Critical Flicker Fusion Threshold (Flicker Fusion)
Time frame: Day 1 and 2
This outcome will be evaluated using the Flicker Fusion System (Lafayette Instrument Company) with the "coincident" stimulus to determine the critical flicker fusion threshold (Hz).
Self-Reported Cognitive Load (NASA-TLX)
Time frame: day 2
The Self-Reported Cognitive Load is measured using the NASA Task Load Index (NASA-TLX). Scores range from 0 to 100, with higher scores indicating greater cognitive load. Capturing subjective workload across six dimensions: mental demand, physical demand, temporal demand, effort, performance, and frustration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximum Cognitive Load, Mental active/pasive activities and Baseline Cognitive Load in people with Cognition and Sedentary Behaviors, run by Pontificia Universidad Catolica de Valparaiso at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography-derived cortical activity (EEG) (time frame: Day 1 and 2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.