跳至主要内容
临床试验/NCT07445113
NCT07445113尚未招募不适用

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

University of Jaén1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2026年2月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Heart rate variability (HRV)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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

干预措施: Guided breathing at 6 bpm with apnea (A) (Procedure)

Experimental Group 2. SDB 6x6x6

Experimental

Guided breathing at 6 bpm with apnea (A) and an I:E:A ratio of 1:1:1.

干预措施: Guided breathing at 6 breaths per minute (bpm) with an inspiration (I) to expiration (E) (Procedure)

Control Group

Placebo Comparator

Breathing education

干预措施: Breathing education (Procedure)

结局指标

主要结局

Heart rate variability (HRV)

时间窗: Baseline

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

Heart rate variability (HRV)

时间窗: Immediately after treatment

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

次要结局

  • Characteristics demographics: Age(Baseline)
  • Characteristics demographics: Gender(Baseline)
  • Anthropometric variables: Weight(Baseline)
  • Anthropometric variables: height(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)
  • SDRR (standard deviation of RR intervals)(Immediately after treatment)
  • Pressure pain thresholds (PPTs)(Immediately after treatment)

研究者

发起方
University of Jaén
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Sedeño Vidal

Full Professor

University of Jaén

研究点 (1)

Loading locations...

相似试验

Diaphragmatic Breathing and Stimulation of the... | 临床试验