Non-invasive Modulation of Autonomic Cardiac Nervous System (MSNA)

Université Catholique de Louvain

Status: Unknown

Conditions: Muscle Sympathetic Nerve Activity; Heart Rate Variability; Autonomic Nervous System

Treatments: Other: Modulation of muscle sympathetic nerve activity

Study type: Interventional

Funder types: Other

Identifiers

NCT04057508

TFE_201904_097

Details and patient eligibility

About

To demonstrate the effect of non invasive vagus nerve (VNS) stimulation on heart rate variability and MSNA signal.

Full description

First part: Assessment of the muscle sympathetic nerve activity (MSNA) at baseline using microneurography performed on the superficial peroneal nerve.

Second part: Acquisition of the MSNA signal during non-invasive VNS and apnea. Non-invasive VNS is performed using several frequencies of stimulation. Maximal and voluntaries apnea are performed at the end of the expiration.

Continuous recording of the following parameters:

• non-invasive arterial blood pressure
• R-R interval
• electrocardiogram
• MSNA activity
• respiratory curve signal
• respiratory rate, oxygen saturation

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers
• >18 years old

Exclusion criteria

• pregnancy and breastfeeding
• smoke
• alcool/energy drinks/coffee consumption, exertion 24h before the participation

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Stimulation protocol

Active Comparator group

Description:

Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order .

Treatment:

Other: Modulation of muscle sympathetic nerve activity

Sham stimulation protocol

Sham Comparator group

Description:

Each subject will be blinded and underwent 3 phases of stimulation (actives (2) and sham (1) comparators) in a randomized order.

Treatment:

Other: Modulation of muscle sympathetic nerve activity