NCT04341649

Multi-device Testing for Autonomic Nervous System Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Beijing Tiantan Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed 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)

Conditions

• Vagus Nerve Stimulation

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-03-23
• Completion: 2020-03-24
• First posted: 2020-04-10
• Last updated: 2020-04-15

Locations

1 site across 1 country: China