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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 3, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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