Multi-device Testing for Autonomic Nervous System Stimulation

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.

Conditions

• Vagus Nerve Stimulation

Interventions

OTHER

Manual Head Massage

Duration 10 minutes.

DEVICE

BREO Helmet Massager

Duration 10 minutes.

DEVICE

Low Laser Therapy (LLT)

Duration 7 minutes.

DEVICE

Sham LLT

Duration 7 minutes.

DEVICE

TENS ear stimulation

Duration 7 minutes.

BEHAVIORAL

Deep and Slow breathing

A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.

BEHAVIORAL

Relaxed Reading time

Duration 10 minutes.

Sponsors & Collaborators

• Beijing Tiantan Hospital

  lead OTHER

Principal Investigators

• Collet Jean-Paul, MD, Phd · Advanced Innovation Center for Human Brain Protection

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-04-01

Primary Completion

2020-03-23

Completion

2020-03-24

Countries

• China

Study Locations