An interventional study of Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) and Guided breathing at 6 bpm with apnea (A) in Healthy Adult Male and Female Volunteers, sponsored by University of Jaén. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by University of Jaén · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
5-minute guided slow deep breathing consisting of a 6-second inhalation and 6-second exhalation. Ratio of 1:1
Procedure: Guided breathing at 6 bpm with apnea (A)
5-minute guided slow deep breathing consisting of a 6-second inhalation, 6-second inspiratory hold, and 6-second exhalation (1:1:1 ratio)
Procedure: Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)
Breathing education
Procedure: Breathing education
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
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
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
Also known as: Control Group
Heart rate variability (HRV)
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Time frame: Baseline
Heart rate variability (HRV)
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
Time frame: Immediately after treatment
Anthropometric variables: Weight
Weight was measured using a calibrated digital scale
Time frame: Baseline
RMSSD (root mean square of successive differences)
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Time frame: Baseline
SDRR (standard deviation of RR intervals)
SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application.
Time frame: Baseline
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
RMSSD (root mean square of successive differences)
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Time frame: Immediately after treatment
SDRR (standard deviation of RR intervals)
SDRR (standard deviation of RR intervals) assessed using the validated Elite HRV application
Time frame: Immediately after treatment
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: Immediately after treatment
Anthropometric variables: height
Height was measured with a calibrated stadiometer
Time frame: Baseline
Characteristics demographics: Age
Age was self-reported by the participants
Time frame: Baseline
Characteristics demographics: Gender
Gender was self-reported by the participants
Time frame: Baseline
Plan to share: Yes — 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)
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Jaén