NCT07379606

Brief Summary

This study investigates the effects of moderate physical exercise and cyclic sighing (breathing training) on stress, cognition, and physiological markers in young adults. It is a randomized cross-over trial with two interventions. Each participant will take part in two intervention sessions:

  • EEG using Emotiv EPOC Flex Gel (32-channel device): 2 minutes with eyes open, 2 minutes with eyes closed, during the interventions, and while performing cognitive test (N-back).
  • Heart rate variability (HRV) using the Polar H10 sensor.
  • SUDS - Subjective Units of Disress Scale for perceived stress.
  • N-back test for cognitive performance using Emotiv App.
  • Blood pressure (systolic and diastolic) and heart rate.
  • Pain threshold measured with a dolorimeter.
  • PANAS-SF - Positive and Negative Affect Schedule. Baseline questionnaires completed by participants the day before the study:
  • PSS-10 - Perceived Stress Scale (Cohen, Kamarck, Mermelstein).
  • MAAS - Mindful Attention Awareness Scale
  • Psychological well-being - short version
  • Mini-COPE - Coping with Stress Inventory
  • Sleep quality and average sleep duration
  • Chronotype questionnaire (morningness-eveningness)
  • GPAQ - Global Physical Activity Questionnaire
  • Pittsburgh Sleep Quality Index The study aims to understand how brief interventions like moderate exercise and breathing techniques affect stress, cognitive performance, and physiological responses in young adults.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Mar 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress37%
Mar 2026Aug 2026

First Submitted

Initial submission to the registry

November 19, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

November 19, 2025

Last Update Submit

January 23, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Mean EEG spectral power in theta, alpha, low beta, high beta, gamma frequency bands during resting-state (eyes-open and eyes-closed)

    Mean spectral power in theta, alpha, low beta, high beta, and gamma frequency bands derived from resting-state EEG recordings collected during eyes-open and eyes-closed conditions. Spectral power will be calculated separately for eyes-open and eyes-closed resting-state conditions.

    Baseline: immediately before intervention; Post-intervention: immediately after completion of the intervention period

  • Heart Rate Variability (HRV)

    HRV will be recorded at three time points. Baseline HRV will be calculated as the average over a 5-minute resting-state period immediately before intervention. HRV during the intervention will be calculated as the average over the entire intervention session (periprocedural). Post-intervention HRV will be calculated as the average over a 5-minute resting-state period immediately after intervention.

    Baseline (average over 5-minute resting-state immediately before intervention); During intervention (average over entire session, periprocedural); Post-intervention (average over 5-minute resting-state immediately after intervention).

Secondary Outcomes (8)

  • Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during N-back task

    Baseline (during N-back task immediately before each intervention session, periprocedural); Post-intervention (during N-back task immediately after each intervention session, periprocedural)

  • Mean EEG spectral power in theta, alpha, low beta, high beta, and gamma frequency bands during intervention session

    During intervention session (periprocedural, averaged over entire session)

  • Perceived Stress measured with the Subjective Units of Distress Scale (SUDS)

    Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

  • Cognitive Performance (N-back)

    Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

  • Blood Pressure

    Baseline: immediately before each intervention session; Post-intervention: immediately after each intervention session

  • +3 more secondary outcomes

Other Outcomes (7)

  • Psychological Well-Being measured with the Short Version of Ryff's Psychological Well-Being Scale

    Day before first intervention.

  • Trait Mindfulness measured with the Mindful Attention Awareness Scale (MAAS)

    Day before first intervention.

  • Coping with Stress measured with the Brief COPE Inventory (mini-COPE)

    Day before first intervention.

  • +4 more other outcomes

Study Arms (2)

Moderate-Intensity Physical Activity (PA)

EXPERIMENTAL

Participants perform 15 minutes of stationary cycling at moderate intensity.

Behavioral: Moderate-Intensity Physical Activity (PA)

Breathing Training - Cyclic Sighing (CS)

EXPERIMENTAL

Participants perform 15 minutes of cyclic sighing.

Behavioral: Breathing Training - Cyclic Sighing (CS)

Interventions

Participants perform 15 minutes of stationary cycling at moderate intensity.

Moderate-Intensity Physical Activity (PA)

Participants perform 15 minutes of cyclic sighing (a breathing technique).

Breathing Training - Cyclic Sighing (CS)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male or female participants,
  • age 18-35,
  • without chronic somatic diseases,
  • no current episode of psychiatric disorder (no active depression, mania, or psychosis),
  • regular sleep schedule in the week prior to the study,
  • not taking psychotropic drugs or medications,
  • non-smoker,
  • not working nightshifts.

You may not qualify if:

  • consumption of alcohol or psychoactive substances the day before or on the day of the study,
  • intense physical activity less than 2 hours before the study,
  • consuming coffee, black tee, energy drinks less than 2 hours before the study,
  • contraindications to moderate-intensity physical activity on cycle ergometer (e.g., recent injuries),
  • contraindications to EEG (e.g., scalp skin conditions preventing proper electrode placement, hypersensitivity to conductive gels or pastes).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2025

First Posted

January 30, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

De-identified individual participant data (IPD) will be shared in the RepOD repository after study completion. An embargo of up to 36 months may apply to allow for publication of primary study results. Data will be available for scientific research purposes.