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Acute effect of Electrical Stimulation of a body nerve located in the ear on heart rate and blood pressure in people with and without Hypertension

Comparison of the acute effect of Transcutaneous Auricular Vagus Nerve Stimulation at two different sites on cardiac autonomic modulation and blood pressure in healthy and Hypertensive individuals: a randomized, crossover clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6tfbjjg
Enrollment
Unknown
Registered
2024-11-27
Start date
2024-11-03
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Interventions

Randomized controlled crossover clinical study with healthy adult individuals diagnosed with hypertension, over 18 years of age. Participants will be randomized to 3 types of intervention, with a sing

Sponsors

Associação educacional nove de julho
Lead Sponsor
Associação educacional nove de julho
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Healthy individuals (without hypertension) and individuals with hypertension aged 18 years or older of both sexes; Mental State Examination as expected in relation to their level of education 13 points for illiterate 18 points for low/medium education and 26 points for high education

Exclusion criteria

Exclusion criteria: Presence of contraindications for Transcutaneous Auricular Vagus Nerve Stimulation (metal cochlear implant at the site of application); history of stroke; Coronary disease chronic obstructive or restrictive pulmonary; disease peripheral arterial disease hypo- or hypernatremia; hyper- or hypothyroidism; chronic atrial fibrillation; Diabetes Mellitus immune-dependent kidney disease chronicle

Design outcomes

Primary

MeasureTime frame
To evaluate and compare the acute effect of Auricular Transcutaneous Electrical Stimulation of the Vagus Nerve on blood pressure using a digital sphygmomanometer in healthy and hypertensive individuals, applied to three different sites of the vagus nerve branch;To evaluate and compare the acute effect of Auricular Transcutaneous Electrical Stimulation of the Vagus Nerve on heart rate variability using a heart rate monitor in healthy and hypertensive individuals, applied to three different sites of the vagus nerve branch

Secondary

MeasureTime frame
To evaluate and compare the acute effect of Auricular Transcutaneous Electrical Stimulation of the Vagus Nerve on oxygen saturation using pulse oximetry in healthy and hypertensive individuals, applied to three different sites of the vagus nerve branch;To evaluate sympathetic activation through bilateral muscle grip test in healthy and hypertensive individuals before and after Auricular Transcutaneous Electrical Stimulation of the Vagus Nerve applied to three different sites of the vagus nerve branch in healthy and hypertensive individuals

Countries

Brazil

Contacts

Public ContactFernanda Corrêa

Universidade Nove de Julho

correafe29@gmail.com+ 55 (11) 973440380

Outcome results

None listed

Source: REBEC (via WHO ICTRP)