Multi-device Testing for Autonomic Nervous System Stimulation

Status Completed

Clinical Trial Summary

The Vagus nerve (VN) serve as an "unconscious inner brain" that integrates messages from the body and provides metabolic homeostatic regulation to various organs.In this study the investigators want to compare different ways to stimulate the vagus nerve to assess their respective effects compared to a sham stimulation.

Each participant will be exposed in a random way to 7 different ways to stimulate the VN:

- Manual Head Massage

- Mechanical Head Massager (BREO Inc. Helmet)

- Low laser Therapy (LLT)

- Sham LLT

- Transcutaneous Electrical Nervous Stimulation (TENS) ear stimulation (as testing phase prototype device)

- Deep and slow breathing (as testing intervention based on video app)

- Relaxed reading time (as control situation)

Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications:

- Study 1: comparison of manual head massage to mechanical Helmet massager and relaxed reading

- Study 2: comparison of LLT with sham LLT and relaxed reading

The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.

Clinical Trial Description

OBJECTIVES Overall objective is to assess the respective effects of the different ways to stimulate the Vagus Nerve on the Heart Rate Variability (HRV) parameters: High Frequency (HF), Low Frequency (LF), Total Power (TP), Heart rate (HR), and blood pressure (BP).

Specific objectives:

- Comparison of Manual Head Massage to Mechanical Head Massager to Control situation

- Comparison of Low Laser Therapy (LLT) to sham LLT to control situation

- Effects of TENS ear stimulation (descriptive)

- Effects of Deep and Slow breathing (descriptive) ;

Study Design

Related Conditions & MeSH terms

Vagus Nerve Stimulation

Clinical Trial Details

NCT number	NCT04341649
Study type	Interventional
Source	Beijing Tiantan Hospital
Contact
Status	Completed
Phase	N/A
Start date	April 1, 2019
Completion date	March 24, 2020

View Details

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