Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System

March 3, 2026 updated by: Ana Sedeño Vidal, University of Jaén

Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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 Contact

  • Name: Ana Sedeño Vidal, Full time professor
  • Phone Number: 34 654428130
  • Email: asedeno@ujaen.es

Study Locations

  • Spain
    • Jaén
      • Jaén, Jaén, Spain, 23071
        • University of Jaén

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy individuals who have not smoked during the 24 hours prior to the study.
  • Healthy individuals who have not drunk alcohol during the 24 hours prior to the study.
  • Healthy individuals who have not drunk coffee during the 24 hours prior to the study.

Exclusion Criteria:

  • Individuals with cardiovascular diseases or neurological disorders.
  • Individuals with cognitive impairment.
  • Individuals taking medications that affect autonomic nervous system function, such as: benzodiazepines, beta-blockers or beta-adrenergic agents.

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group 1. SDB 6x 6
Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) ratio of 1:1
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.
Other Names:
  • Experimental Group 2.SDB 6x6x6
Experimental: Experimental Group 2. SDB 6x6x6
Guided breathing at 6 bpm with apnea (A) and an I:E:A ratio of 1:1:1.
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.
Other Names:
  • Experimental Group 1. SDB 6x6
Placebo Comparator: Control Group
Breathing education
Procedure: Breathing education
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate variability (HRV)
Time Frame: Baseline
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Baseline
Heart rate variability (HRV)
Time Frame: Immediately after treatment
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
Immediately after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric variables: Weight
Time Frame: Baseline
Weight was measured using a calibrated digital scale
Baseline
RMSSD (root mean square of successive differences)
Time Frame: Baseline
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Baseline
SDRR (standard deviation of RR intervals)
Time Frame: Baseline
SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application.
Baseline
Pressure pain thresholds (PPTs)
Time Frame: Baseline

Pressure pain sensitivity was evaluated using a digital algometer (FPIX; Wagner Instruments, Greenwich, CT, EE.UU).

PPTs were measured at the spinous process of C3-C4.
Baseline
Anthropometric variables: height
Time Frame: Baseline
Height was measured with a calibrated stadiometer
Baseline
Characteristics demographics: Age
Time Frame: Baseline
Age was self-reported by the participants
Baseline
Characteristics demographics: Gender
Time Frame: Baseline
Gender was self-reported by the participants
Baseline
RMSSD (root mean square of successive differences)
Time Frame: Immediately after treatment
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Immediately after treatment
SDRR (standard deviation of RR intervals)
Time Frame: Immediately after treatment
SDRR (standard deviation of RR intervals) assessed using the validated Elite HRV application
Immediately after treatment
Pressure pain thresholds (PPTs)
Time Frame: Immediately after treatment
Pressure pain sensitivity was evaluated using a digital algometer (FPIX; Wagner Instruments, Greenwich, CT, EE.UU). PPTs were measured at the spinous process of C3-C4
Immediately after treatment

Collaborators and Investigators

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

Sponsor

University of Jaén

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

February 15, 2026

Primary Completion (Estimated)

March 15, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

February 14, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DB and ANS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data of the study will be available under reasonable request to the corresponding author or published in the Repository of the university of Jaen (www.ruja.es)

IPD Sharing Time Frame

From the publication of the manuscript about the study report until with no end date.

IPD Sharing Access Criteria

Any request by email will be attended, as well as everybody could access to RUJA repository as it is public. For access, people will have to request by email or access to www.ruja.es

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

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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