NCT07087236

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Mar 2025May 2026

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2026

Expected
Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

10 months

First QC Date

July 6, 2025

Last Update Submit

July 23, 2025

Conditions

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    Day 1 and 2

  • Eye-Tracking Metrics

    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)

    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)

    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)

    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

Study Arms (3)

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

Interventions

Participants will perform a working memory task (through N-back 1-to-3) to evaluate the upper limit of cognitive demand.

Maximum Cognitive Load Condition

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

Experimental Mentally Active and Mentally Passive Sedentary Activities

Participants will sit quietly for 5 minutes to establish baseline spontaneous neurophysiological parameters.

Baseline Cognitive Condition

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Católica de Valparaíso

Viña del Mar, Chile

Location

MeSH Terms

Conditions

Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Doble-blind. Both participants and the statistician were blinded to the intervention condition; however, the assessors administering the activities were not blinded.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 25, 2025

Study Start

March 1, 2025

Primary Completion

December 31, 2025

Study Completion (Estimated)

May 30, 2026

Last Updated

July 25, 2025

Record last verified: 2025-07

Locations