Stress, Psychological CumulativeVNN-HRV-CCSNCT06499662
Randomised Clinical Trial to Determine the Effect of Vagus Nerve Neurodynamics on the Neurovegetative Nerve System in People With Chronic Stress.
A study testing Vagus Nerve Neurodynamics, Guided Breathing and Manual Therapy in people with Stress, Psychological Cumulative and Chronic Disease, run by Marta de la Plaza at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stress, Psychological Cumulative, Chronic Disease, Heart Rate Variability
- What is being tested?
- Vagus Nerve Neurodynamics, Guided Breathing and Manual Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 23 Mar 2024to 7 Jul 2024
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Cancer.
- Neurological disorders affecting muscle tone.
- Underlying conditions such as diabetes mellitus or arterial hypertension.
- Use of beta-blockers.
- Arrhythmias or other cardiac diseases
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Stress, Psychological Cumulative, Chronic Disease, Heart Rate Variability, Vagal Nerve Stimulation, Autonomic Nervous System Diseases
- Being tested
- Vagus Nerve Neurodynamics, Guided Breathing, Manual Therapy
- Medical subject headings
- Stress, Psychological, Chronic Disease, Autonomic Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve NeurodynamicsOther
This intervention involves passive cervical movements designed to enhance vagus nerve functionality.
Guided BreathingOther
This intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute.
Manual TherapyOther
This intervention includes suboccipital inhibition techniques applied during the session.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Guided Breathing; Other: Manual Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From the start of the study until 7 minutes post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study start23 Mar 2024
- Primary completion7 Jul 2024
- Study completion7 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, Psychological CumulativeStudies 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
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marta de la Plaza
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Responsible party
- Sponsor-investigator, Marta de la Plaza, European University of Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499662
- Sponsor's protocol ID
- VNNHRV2024-01
- Acronym
- VNN-HRV-CCS
- Status last verified
- Jul 2024
- First submitted
- 7 Jul 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06499662
- Acronym / sponsor ID
- VNN-HRV-CCS / VNNHRV2024-01
- Conditions
- Stress, Psychological Cumulative, Chronic Disease, Heart Rate Variability, Vagal Nerve Stimulation, Autonomic Nervous System Diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Marta de la PlazaUniversity, hospital or other
- Collaborators
- Universidad Rey Juan Carlos
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 7 Jul 2024 (actual)
- Study completion
- 7 Jul 2024 (actual)
- First posted
- 12 Jul 2024 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy | Active comparator | Other: Vagus Nerve Neurodynamics, Other: Guided Breathing, Other: Manual TherapyParticipants 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. |
| Guided Breathing with Manual Therapy | Active comparator | Other: Guided Breathing, Other: Manual TherapyParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Vagus Nerve NeurodynamicsThis intervention involves passive cervical movements designed to enhance vagus nerve functionality. | Other | Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy |
| Guided BreathingThis intervention consists of diaphragmatic breathing guided by a recording to maintain a rate of 6 breaths per minute. | Other | Guided Breathing with Manual Therapy, Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy |
| Manual TherapyThis intervention includes suboccipital inhibition techniques applied during the session. | Other | Guided Breathing with Manual Therapy, Vagus Nerve Neurodynamics and Guided Breathing with Manual Therapy |
Primary outcome
Change in Heart Rate Variability (HRV)
Time frame: From the start of the study until 7 minutes post-intervention.
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).
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 12 Jul 2024.
- Individual participant dataSharing planned: No
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 Vagus Nerve Neurodynamics, Guided Breathing and Manual Therapy in people with Stress, Psychological Cumulative and Chronic Disease, run by Marta de la Plaza 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 11 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 12 Jul 2024. 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. 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?
Change in Heart Rate Variability (HRV) (time frame: From the start of the study until 7 minutes post-intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2024.