Clinical trial NCT06499662: Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress.
Official title: The Influence of Vagus Nerve Neurodynamics on Heart Rate Variability Measured With Sensors in Patients Suffering From Chronic Stress: A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychological Cumulative
Chronic Disease
Heart Rate Variability
Vagal Nerve Stimulation
Autonomic Nervous System Diseases
Lead sponsor: European University of Madrid
Sponsor class: OTHER
Collaborators: name: Universidad Rey Juan Carlos
First posted: 2024-07-12
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in Heart Rate Variability (HRV)
timeFrame: From the start of the study until 7 minutes post-intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Marta de la plaza
Study officials:
References: