Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Jaén

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    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.

  • Guided breathing at 6 bpm with apnea (A)

    Procedure/Surgery

    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.

  • Breathing education

    Procedure/Surgery

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Experimental Group 1. SDB 6x 6Experimental treatment 1 intervention
Group B: Experimental Group 2. SDB 6x6x6Experimental treatment 1 intervention
Group C: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Heart rate variability (HRV)

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

Time frame
Baseline
2

Heart rate variability (HRV)

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

Time frame
Immediately after treatment

Secondary outcomes

1

Anthropometric variables: Weight

Weight was measured using a calibrated digital scale

Time frame
Baseline
2

RMSSD (root mean square of successive differences)

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

Time frame
Baseline
3

SDRR (standard deviation of RR intervals)

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

Time frame
Baseline
4

Pressure pain thresholds (PPTs)

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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