Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress.

NCT06499662 | Completed DMC

• 1 other identifier: VNNHRV2024-01
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stress, Psychological Cumulative; Chronic Disease; Heart Rate Variability; Vagal Nerve Stimulation; Autonomic Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy

ACTIVE COMPARATOR

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; Other: Guided Breathing; Other: Manual Therapy

Guided Breathing with Manual Therapy

ACTIVE COMPARATOR

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; Other: Manual Therapy

Interventions

Vagus Nerve Neurodynamics OTHER

This intervention involves passive cervical movements designed to enhance vagus nerve functionality.

Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy

Guided Breathing OTHER

This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.

Guided Breathing with Manual Therapy; Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy

Manual Therapy OTHER

This intervention includes suboccipital inhibition techniques applied during the session.

Guided Breathing with Manual Therapy; Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marta de la Plaza: lead
• Universidad Rey Juan Carlos: collaborator

Study Sites (1)

Marta de la plaza

Madrid, 28670, Spain

Location

MeSH Terms

Conditions

Stress, Psychological; Chronic Disease; Autonomic Nervous System Diseases

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study will employ simple blinding. Participants will be blinded to the intervention group to which they belong. Outcome assessors will also be blinded to group assignment to ensure that heart rate variability (HRV) measurements are not influenced by participants' knowledge of the intervention received. Staff delivering interventions will not be blinded due to the nature of neurodynamic and guided breathing techniques, which require knowledge of the specific protocol applied.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Model Details: This study is a controlled clinical trial with a parallel design. Participants will be randomised into two groups: one group will receive a combination of vagus nerve neurodynamics, 6 bpm guided breathing and manual therapy, while the other group will receive only 6 bpm guided breathing and manual therapy. Each group will be treated simultaneously and the results will be compared between groups to assess the effect of neurodynamics on heart rate variability in chronically stressed patients.

Study Record Dates

• First Submitted: July 7, 2024
• First Posted: July 12, 2024
• Study Start: March 23, 2024
• Primary Completion: July 7, 2024
• Study Completion: July 7, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)