Healthy Adult Male and Female VolunteersNCT07445113
Diaphragmatic Breathing and Stimulation of the Autonomic Nervous System
A study testing Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E), Guided breathing at 6 bpm with apnea (A) and Breathing education in people with Healthy Adult Male and Female Volunteers, run by University of Jaén at 1 site in Spain.
Trial summary
Introduction: Slow, deep breathing has demonstrated beneficial effects on the autonomic nervous system, particularly by increasing parasympathetic activity through vagal nerve modulation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E), Guided breathing at 6 bpm with apnea (A) and Breathing education
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 26 Dec 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E), Guided breathing at 6 bpm with apnea (A), Breathing education
- Keywords
- Slow diaphragmatic breathing, autonomic nervous system, heart rate variability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)Procedure or surgery
Also called 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.
Guided breathing at 6 bpm with apnea (A)Procedure or surgery
Also called Experimental Group 2.SDB 6x6x6
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 educationProcedure or surgery
Also called Control Group
Breathing education consists of teaching individuals to understand, control, and optimize their breathing patterns.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group 1. SDB 6x6 | Experimental | 5-minute guided slow deep breathing consisting of a 6-second inhalation and 6-second exhalation. Ratio of 1:1 Receives: Procedure: Guided breathing at 6 bpm with apnea (A) |
| Experimental Group 2. SDB 6x6x6 | Experimental | 5-minute guided slow deep breathing consisting of a 6-second inhalation, 6-second inspiratory hold, and 6-second exhalation (1:1:1 ratio) Receives: Procedure: Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) |
| Control Group | Placebo comparator | Breathing education Receives: Procedure: Breathing education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Measured: Baseline
Heart rate variability (HRV)
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
Measured: Immediately after treatment
Secondary outcomes (10)
Anthropometric variables: Weight
Weight was measured using a calibrated digital scale
Measured: Baseline
RMSSD (root mean square of successive differences)
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Measured: Baseline
SDRR (standard deviation of RR intervals)
SDRR (standard deviation of RR intervals): assessed using the validated Elite HRV application.
Measured: 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.
Measured: Baseline
RMSSD (root mean square of successive differences)
RMSSD (root mean square of successive differences) measured using the validated Elite HRV application
Measured: Immediately after treatment
SDRR (standard deviation of RR intervals)
SDRR (standard deviation of RR intervals) assessed using the validated Elite HRV application
Measured: 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
Measured: Immediately after treatment
Anthropometric variables: height
Height was measured with a calibrated stadiometer
Measured: Baseline
Characteristics demographics: Age
Age was self-reported by the participants
Measured: Baseline
Characteristics demographics: Gender
Gender was self-reported by the participants
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start26 Dec 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jaén
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Sedeño Vidal, University of Jaén
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445113
- Sponsor's protocol ID
- DB and ANS
- Status last verified
- Mar 2026
- First submitted
- 14 Feb 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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)
Publications
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.
PubMed 31978501Gholamrezaei 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.
PubMed 34378834Cai 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.
PubMed 35808157Alabdo 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.
PubMed 40575945
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Diaphragmatic Breathing Through Slow, Deep Respiration on Vagal Nerve Modulation and Stimulation of the Autonomic Nervous System
- ClinicalTrials.gov ID
- NCT07445113
- Acronym / sponsor ID
- DB and ANS
- Conditions
- Healthy Adult Male and Female Volunteers
- Keywords
- Slow diaphragmatic breathing, autonomic nervous system, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of JaénUniversity, hospital or other
- Study start
- 26 Dec 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Group 1. SDB 6x6 | Experimental | Procedure: Guided breathing at 6 bpm with apnea (A)5-minute guided slow deep breathing consisting of a 6-second inhalation and 6-second exhalation. Ratio of 1:1 |
| Experimental Group 2. SDB 6x6x6 | Experimental | Procedure: Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)5-minute guided slow deep breathing consisting of a 6-second inhalation, 6-second inspiratory hold, and 6-second exhalation (1:1:1 ratio) |
| Control Group | Placebo comparator | Procedure: Breathing educationBreathing education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E)Also: Experimental Group 1. SDB 6x6Spontaneous 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. | Procedure or surgery | Experimental Group 2. SDB 6x6x6 |
| Guided breathing at 6 bpm with apnea (A)Also: Experimental Group 2.SDB 6x6x6Spontaneous 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. | Procedure or surgery | Experimental Group 1. SDB 6x6 |
| Breathing educationAlso: Control GroupBreathing education consists of teaching individuals to understand, control, and optimize their breathing patterns. | Procedure or surgery | Control Group |
Primary outcome
Heart rate variability (HRV)
Time frame: Baseline
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor.
Heart rate variability (HRV)
Time frame: Immediately after treatment
Heart rate variability (HRV): measured using the Polar H10 heart rate sensor
10 secondary outcomes
Anthropometric variables: Weight
Time frame: Baseline
RMSSD (root mean square of successive differences)
Time frame: Baseline
SDRR (standard deviation of RR intervals)
Time frame: Baseline
Pressure pain thresholds (PPTs)
Time frame: Baseline
RMSSD (root mean square of successive differences)
Time frame: Immediately after treatment
SDRR (standard deviation of RR intervals)
Time frame: Immediately after treatment
Pressure pain thresholds (PPTs)
Time frame: Immediately after treatment
Anthropometric variables: height
Time frame: Baseline
Characteristics demographics: Age
Time frame: Baseline
Characteristics demographics: Gender
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Background: PubMed 31978501Jafari 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.
- Background: PubMed 34378834Gholamrezaei 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.
- Background: PubMed 35808157Cai 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.
- Background: PubMed 40575945Alabdo 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.
- Individual participant dataSharing planned: 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E), Guided breathing at 6 bpm with apnea (A) and Breathing education in people with Healthy Adult Male and Female Volunteers, run by University of Jaén at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445113, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.