Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress. (VNN-HRV-CCS)

The Influence of Vagus Nerve Neurodynamics on Heart Rate Variability Measured With Sensors in Patients Suffering From Chronic Stress: A Controlled Clinical Trial

This unicentric, controlled clinical trial aims to evaluate the effects of vagus nerve neurodynamics and 6 bpm guided breathing, combined with manual therapy, on heart rate variability (HRV) in patients suffering from chronic stress. A total of 62 participants will be randomly assigned into two groups: one receiving guided breathing and neurodynamics with manual therapy, and the other receiving only guided breathing with manual therapy. HRV will be monitored using Polar® H10 sensors. The primary outcome is the change in HRV, measured pre- and post-intervention. The study is ethically approved by the Hospital Clínico San Carlos.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Autonomic Nervous System Diseases; Heart Rate Variability; Vagal Nerve Stimulation; Stress, Psychological Cumulative
• Intervention / Treatment: Other: Vagus Nerve Neurodynamics; Other: Guided Breathing; Other: Manual Therapy

Detailed Description

This unicentric, controlled clinical trial investigates the impact of vagus nerve neurodynamics and guided breathing at a rate of 6 breaths per minute (bpm), in conjunction with manual therapy, on heart rate variability (HRV) in patients with chronic stress.

The study involves 62 participants who will be randomly allocated into two groups. Group 1 will receive a protocol of guided breathing combined with neurodynamics and manual therapy, while Group 2 will follow a protocol of guided breathing with manual therapy only.

Each participant will undergo a 15-minute intervention session where HRV will be continuously monitored using Polar® H10 sensors. The intervention will include guided diaphragmatic breathing at 6 bpm to standardize the respiratory rate across participants, ensuring that HRV measurements reflect the effects of neurodynamics rather than respiratory variations.

The neurodynamics technique involves passive movements in the cervical region to enhance the functionality of the vagus nerve, potentially influencing HRV. This technique will be applied during the intervention period, with specific movements synchronized with the participants' respiratory cycle.

Prior to the intervention, baseline HRV will be recorded during a 7-minute rest period. Post-intervention HRV measurements will also be taken for 7 minutes while participants remain in a supine position. Data analysis will focus on comparing the HRV changes between the two groups, providing insights into the effectiveness of combining neurodynamics with guided breathing and manual therapy.

The study adheres to ethical guidelines and has received approval from the Medical Research Ethics Committee of Hospital Clínico San Carlos

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28670
    • Marta de la plaza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Individuals aged 18 years or older.
• Self-perceived chronic stress for at least six months.
• Willingness to provide informed consent and comply with the study procedures

Exclusion Criteria:

• Consumption of tea, caffeine, energy drinks, alcohol, or tobacco within two hours prior to the study.
• Significant neck pain or headache.
• Carotid sinus syndrome.
• Pregnancy.
• Recent cervical or cardiac surgery.
• Recent significant trauma.
• Cancer.
• Neurological disorders affecting muscle tone.
• Underlying conditions such as diabetes mellitus or arterial hypertension.
• Use of beta-blockers.
• Arrhythmias or other cardiac diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy; Participants in this arm will receive a combination of vagus nerve neurodynamics and guided breathing at a rate of 6 breaths per minute (bpm), along with manual therapy. The neurodynamics intervention involves passive movements in the cervical region to enhance vagus nerve function, synchronized with the guided breathing. The manual therapy will include suboccipital inhibition techniques to complement the intervention. The total duration of the intervention will be 15 minutes.	Other: Vagus Nerve Neurodynamics; This intervention involves passive cervical movements designed to enhance vagus nerve functionality.; Other: Guided Breathing; This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.; Other: Manual Therapy; This intervention includes suboccipital inhibition techniques applied during the session.
Active Comparator: Guided Breathing with Manual Therapy; Participants in this arm will receive only guided breathing at a rate of 6 breaths per minute (bpm) along with manual therapy. The guided breathing will be diaphragmatic, following a recording that marks the times for inhalation and exhalation. The manual therapy will include suboccipital inhibition techniques applied during the breathing. The total duration of the intervention will be 15 minutes.	Other: Guided Breathing; This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.; Other: Manual Therapy; This intervention includes suboccipital inhibition techniques applied during the session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Heart Rate Variability (HRV)	The primary outcome measure is the change in heart rate variability (HRV) from baseline to post-intervention. HRV will be measured using a Polar® H10 sensor band placed on the participants' chest. HRV data will be recorded during a 7-minute period before the intervention (at rest), during the 15-minute intervention, and during a 7-minute period after the intervention (at rest). Specific HRV parameters to be analyzed include RMSSD (Root Mean Square of the Successive Differences), pNN50 (percentage of adjacent NN intervals that differ by more than 50 ms), and high-frequency power (HF power).	From the start of the study until 7 minutes post-intervention.

Collaborators and Investigators

• Sponsor: Marta de la Plaza
• Collaborators: Universidad Rey Juan Carlos

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2024
• Primary Completion (Actual): July 7, 2024
• Study Completion (Actual): July 7, 2024

Study Registration Dates

• First Submitted: July 7, 2024
• First Submitted That Met QC Criteria: July 7, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 7, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pathologic Processes; Disease Attributes; Stress, Psychological; Nervous System Diseases; Chronic Disease; Primary Dysautonomias; Autonomic Nervous System Diseases
• Other Study ID Numbers: VNNHRV2024-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No