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NCT Number: NCT07445113

Diaphragmatic Breathing 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Jaen

Jaén, 23071, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Experimental Group 1. SDB 6x6

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.

Other names: Experimental Group 2.SDB 6x6x6

Breathing education

Procedure

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

Other names: Control Group

Primary outcomes

  1. Heart rate variability (HRV)

    Time frame: Baseline

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

  2. Heart rate variability (HRV)

    Time frame: Immediately after treatment

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

Secondary outcomes

  1. Anthropometric variables: Weight

    Time frame: Baseline

    Weight was measured using a calibrated digital scale

  2. RMSSD (root mean square of successive differences)

    Time frame: Baseline

    RMSSD (root mean square of successive differences) measured using the validated Elite HRV application

  3. SDRR (standard deviation of RR intervals)

    Time frame: Baseline

    SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application.

  4. 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.

  5. 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

  6. SDRR (standard deviation of RR intervals)

    Time frame: Immediately after treatment

    SDRR (standard deviation of RR intervals) assessed using the validated Elite HRV application

  7. 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

  8. Anthropometric variables: height

    Time frame: Baseline

    Height was measured with a calibrated stadiometer

  9. Characteristics demographics: Age

    Time frame: Baseline

    Age was self-reported by the participants

  10. Characteristics demographics: Gender

    Time frame: Baseline

    Gender was self-reported by the participants

Study contacts

Contact information is provided by the study sponsor or research team.

Ana Sedeño Vidal, Full time professor

CONTACT

[email protected]

34 654428130

Sponsors and collaborators

Lead sponsor

University of Jaén

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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