Sedentary Activities and Passive-to-Intense Effects on Neuro-Cognitive States (SAPIENS)

July 23, 2025 updated by: Carlos Cristi Montero, Pontificia Universidad Catolica de Valparaiso
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Viña Del Mar, Chile
        • Pontificia Universidad Católica de Valparaíso

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Baseline Cognitive Condition
Behavioral: Baseline Cognitive Load
Participants will sit quietly for 5 minutes to establish baseline spontaneous neurophysiological parameters.
Active Comparator: Maximum Cognitive Load Condition
Behavioral: Maximum Cognitive Load
Participants will perform a working memory task (through N-back 1-to-3) to evaluate the upper limit of cognitive demand.
Experimental: Experimental Mentally Active and Mentally Passive Sedentary Activities
Behavioral: Mental active/pasive activities

Participants 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 1 and 2
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.
Day 1 and 2
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.
Day 1 and 2
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).
Day 1 and 2
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).
Day 1 and 2
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.
day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pontificia Universidad Catolica de Valparaiso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIOEPUCV-H 858-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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