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Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System

NCT07445113 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-03-05

No results posted yet for this study

Summary

Introduction:

Slow, deep breathing has demonstrated beneficial effects on the autonomic nervous system, particularly by increasing parasympathetic activity through vagal nerve modulation. Previous studies suggest that this breathing pattern optimizes the sympathovagal balance, modifies physiological parameters such as heart rate, blood pressure, and oxygen saturation, and influences variables including heart rate variability (HRV) and RR intervals.

Objectives:

To analyze the effects of different slow deep breathing (SDB) training modalities on vagal tone regulation. Secondary objectives include evaluating their impact on heart rate and rhythm, HRV, cardiac beat intervals, blood pressure, and oxygen saturation.

Methodology:

A randomized, controlled, single-blind, parallel-design clinical trial will be conducted. Sixty healthy participants will be enrolled and allocated into three groups: two experimental groups (SDB with and without apnea) and one control group (breathing education). Pre- and post-intervention measurements will include HRV, RR intervals, heart rate, blood pressure, oxygen saturation, and cervical joint variables. Data will be analyzed using repeated-measures ANOVA and statistical tests appropriate for each variable type, with a significance level set at 5%.

Expected Results:

SDB-based interventions are expected to produce significant improvements in vagal regulation, increasing heart rate variability and favorably modifying the aforementioned physiological parameters compared with the control group.

Conditions

  • Healthy Adult Male and Female Volunteers

Interventions

PROCEDURE

Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)

Spontaneous breathing in adults typically ranges between 12 and 20 breaths per minute (bpm), whereas slow, deep breathing (SDB) is usually performed as guided breathing at approximately 4 to 6 bpm.

PROCEDURE

Guided breathing at 6 bpm with apnea (A)

Spontaneous breathing in adults typically ranges between 12 and 20 breaths per minute (bpm), whereas slow, deep breathing (SDB) is usually performed as guided breathing at approximately 4 to 6 bpm.

PROCEDURE

Breathing education

Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.

Sponsors & Collaborators

  • University of Jaén

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-02-15
Primary Completion
2026-03-15
Completion
2026-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07445113 on ClinicalTrials.gov