HypertensionNCT03000842
Effects of Transcutaneous Vagal Nerve Stimulation on Hemodynamics Parameters
A study testing transcutaneous vagal nerve stimulation on and transcutaneous vagal nerve stimulation off in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul.
Trial summary
The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- transcutaneous vagal nerve stimulation on and transcutaneous vagal nerve stimulation off
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jun 2017
- 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 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Normotensive group Inclusion Criteria:
- healthy volunteers
- sign the consent term
Normotensive group Exclusion Criteria:
- smokers
- alcoholism
- drug treatment
- skin lesion in the ear region
- chronic or acute diseases
- pregnancy
- be participating in another research protocol
- high performance athletes
- recent surgery
- vaso-vagal syndrome
Hypertensive group Inclusion Criteria:
- hypertensive diagnosis (with or without anti-hypertensive drugs treatment) or
- ambulatory blood pressure monitoring (ABPM) >130/85
- sign the consent term
Hypertensive group Exclusion Criteria:
- smokers
- alcoholism
- beta-blockers treatment
- skin lesion in the ear region
- associated diseases
- pregnancy
- be participating in another research protocol
- high performance athletes
- recent surgery
- vaso-vagal syndrome
About this study
Official title: Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects
The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct stimulation of the vagal nerve. However, there are still no strong evidences about it actions regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at rest and after orthostatic position
- Conditions
- Hypertension
- Being tested
- transcutaneous vagal nerve stimulation on, transcutaneous vagal nerve stimulation off
- Keywords
- autonomic control, transcutaneous vagal nerve stimulation, transauricular vagal nerve stimulation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous vagal nerve stimulation onDevice
electrical current on positioned in the ear to estimate vagal branch of auricular nerve
transcutaneous vagal nerve stimulation offDevice
an electrical current off positioned in the ear to estimate vagal branch of auricular nerve
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | transcutaneous vagal nerve stimulation Receives: Device: transcutaneous vagal nerve stimulation on; Device: transcutaneous vagal nerve stimulation off |
| Hypertensive Subjects | Experimental | transcutaneous vagal nerve stimulation Receives: Device: transcutaneous vagal nerve stimulation on; Device: transcutaneous vagal nerve stimulation off |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic control response to transcutaneous vagal nerve stimulation
sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
Measured: 40 minutes
Secondary outcomes (2)
Blood pressure changes to transcutaneous vagal nerve stimulation
systemic response to non-invasive vagal nerve stimulation
Measured: 40 minutes
Heart Rate changes to transcutaneous vagal nerve stimulation
cardiac response to non-invasive vagal nerve stimulation
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000842
- Sponsor's protocol ID
- 5260/16
- Status last verified
- Dec 2016
- First submitted
- 20 Dec 2016
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Vagal Nerve Stimulation (tVNS) on Blood Pressure, Heart Rate and Autonomic Control in Hypertensive Subjects
- ClinicalTrials.gov ID
- NCT03000842
- Acronym / sponsor ID
- 5260/16
- Conditions
- Hypertension
- Keywords
- autonomic control, transcutaneous vagal nerve stimulation, transauricular vagal nerve stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Instituto de Cardiologia do Rio Grande do SulUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 22 Dec 2016 (estimated)
- 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.
The vagal stimulation is a promising therapy for a lot of disorders as well as hemodynamic regulatory way. In order to minimize the harm of a surgery chip implantation, actually it was developing a non-invasive device that is able to stimulate the auricular branch of vagal nerve. It has been shown that trans-auricular vagal stimulation (tVNS) causes direct stimulation of the vagal nerve. However, there are still no strong evidences about it actions regarding the autonomic modulation. The aim of this study is to evaluate effects of tVNS on heart rate, blood pressure and the autonomic control in healthy and hypertensive subjects, at rest and after orthostatic position
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: transcutaneous vagal nerve stimulation on, Device: transcutaneous vagal nerve stimulation offtranscutaneous vagal nerve stimulation |
| Hypertensive Subjects | Experimental | Device: transcutaneous vagal nerve stimulation on, Device: transcutaneous vagal nerve stimulation offtranscutaneous vagal nerve stimulation |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| transcutaneous vagal nerve stimulation onelectrical current on positioned in the ear to estimate vagal branch of auricular nerve | Device | Healthy Subjects, Hypertensive Subjects |
| transcutaneous vagal nerve stimulation offan electrical current off positioned in the ear to estimate vagal branch of auricular nerve | Device | Healthy Subjects, Hypertensive Subjects |
Primary outcome
Autonomic control response to transcutaneous vagal nerve stimulation
Time frame: 40 minutes
sympathetic and parasympathetic response to non-invasive vagal nerve stimulation
2 secondary outcomes
Blood pressure changes to transcutaneous vagal nerve stimulation
Time frame: 40 minutes
Heart Rate changes to transcutaneous vagal nerve stimulation
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous vagal nerve stimulation on and transcutaneous vagal nerve stimulation off in people with Hypertension, run by Instituto de Cardiologia do Rio Grande do Sul.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 22 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Autonomic control response to transcutaneous vagal nerve stimulation (time frame: 40 minutes). 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 22 Dec 2016.