- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07087236
- Original Trial
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
Enrolling by invitation
Conditions
Study Type
Interventional
Enrollment (Estimated)
8
Phase
- 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
-
-
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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
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 |
Intervention / Treatment |
|---|---|
|
Active Comparator: Baseline Cognitive Condition
|
Participants will sit quietly for 5 minutes to establish baseline spontaneous neurophysiological parameters.
|
|
Active Comparator: Maximum Cognitive Load Condition
|
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
|
Participants will engage in 7 activities, presented in a randomly assigned order across two separate days, to assess their impact on cognitive load:
|
What is the study measuring?
Primary Outcome Measures
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
|
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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.
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)
March 1, 2025
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
May 30, 2026
Study Registration Dates
First Submitted
July 6, 2025
First Submitted That Met QC Criteria
July 23, 2025
First Posted (Actual)
July 25, 2025
Study Record Updates
Last Update Posted (Actual)
July 25, 2025
Last Update Submitted That Met QC Criteria
July 23, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Other Study ID 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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