Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System

NCT07445113 | Not Yet Recruiting

• 1 other identifier: DB and ANS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Slow diaphragmatic breathing; autonomic nervous system; heart rate variability

Outcome Measures

Primary Outcomes (2)

• Heart rate variability (HRV)

  Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.

  Baseline

• Heart rate variability (HRV)

  Heart rate variability (HRV): measured using the Polar H10 heart rate sensor

  Immediately after treatment

Secondary Outcomes (10)

• Anthropometric variables: Weight

  Baseline

• RMSSD (root mean square of successive differences)

  Baseline

• SDRR (standard deviation of RR intervals)

  Baseline

• Pressure pain thresholds (PPTs)

  Baseline

• RMSSD (root mean square of successive differences)

  Immediately after treatment

Study Arms (3)

Experimental Group 1. SDB 6x 6

EXPERIMENTAL

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)

Experimental Group 2. SDB 6x6x6

EXPERIMENTAL

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)

Control Group

PLACEBO COMPARATOR

Breathing education

Procedure: Breathing education

Interventions

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

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.

Also known as: Experimental Group 1. SDB 6x6

Experimental Group 2. SDB 6x6x6

Guided breathing at 6 bpm with apnea (A) PROCEDURE

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.

Also known as: Experimental Group 2.SDB 6x6x6

Experimental Group 1. SDB 6x 6

Breathing education PROCEDURE

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

Also known as: Control Group

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Jaén: lead

Study Sites (1)

University of Jaen

Jaén, Jaén, 23071, Spain

Location

Related Publications (4)

• Jafari H, Gholamrezaei A, Franssen M, Van Oudenhove L, Aziz Q, Van den Bergh O, Vlaeyen JWS, Van Diest I. Can Slow Deep Breathing Reduce Pain? An Experimental Study Exploring Mechanisms. J Pain. 2020 Sep-Oct;21(9-10):1018-1030. doi: 10.1016/j.jpain.2019.12.010. Epub 2020 Jan 22.

  PMID: 31978501 BACKGROUND

• Gholamrezaei A, Van Diest I, Aziz Q, Pauwels A, Tack J, Vlaeyen JWS, Van Oudenhove L. Effect of slow, deep breathing on visceral pain perception and its underlying psychophysiological mechanisms. Neurogastroenterol Motil. 2022 Apr;34(4):e14242. doi: 10.1111/nmo.14242. Epub 2021 Aug 11.

  PMID: 34378834 BACKGROUND

• Cai Y, Wang Z, Zhang W, Kong W, Jiang J, Zhao R, Wang D, Feng L, Ni G. Estimation of Heart Rate and Energy Expenditure Using a Smart Bracelet during Different Exercise Intensities: A Reliability and Validity Study. Sensors (Basel). 2022 Jun 21;22(13):4661. doi: 10.3390/s22134661.

  PMID: 35808157 BACKGROUND

• Alabdo A, Oflazoglu B, Kus MM, Cakan P, Ugras S, Yildiz S. Cardiac Autonomic Control Reflects Sympathovagal Changes Associated With Withholding Urination. Neurourol Urodyn. 2025 Sep;44(7):1512-1520. doi: 10.1002/nau.70105. Epub 2025 Jun 27.

  PMID: 40575945 BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Ana Sedeño Vidal, Full time professor

CONTACT

34 654428130; asedeno@ujaen.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 14, 2026
• First Posted: March 3, 2026
• Study Start: February 15, 2026
• Primary Completion: March 15, 2026
• Study Completion: May 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From the publication of the manuscript about the study report until with no end date.
• 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

Locations

ES (1)