Multi-device Testing for Autonomic Nervous System Stimulation

Not Applicable

Completed

• Conditions: Vagus Nerve Stimulation
• Interventions: Device: Low Laser Therapy (LLT); Behavioral: Relaxed Reading time; Other: Manual Head Massage; Device: BREO Helmet Massager; Device: TENS ear stimulation; Behavioral: Deep and Slow breathing; Device: Sham LLT

• Registration Number: NCT04341649
• Lead Sponsor: Beijing Tiantan Hospital

Brief 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)

Study Timeline

• Study Start: 2019-04-01
• Primary Completion: 2020-03-23
• Study Completion: 2020-03-24
• Study First Submitted: 2020-03-25
• Status Verified: 2020-04
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-10
• Last Update Submitted: 2020-04-14
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Healthy volunteers aged 20 to 40 in normal context

Exclusion Criteria

• To have work night shift the night before
• To use certain drugs that affect the ANS (beta blockers, beta stimulant, hypnotic, for instance)
• To be in situation of unusual life stress
• To have a chronic disease that require some daily treatment
• Not to stay in Beijing for the duration of the investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Low Laser Therapy	Low Laser Therapy (LLT)	Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng).
Relaxed Reading time	Relaxed Reading time	Participants will read the newspaper in a quiet environment.
Head massage by therapist	Manual Head Massage	Head massage therapist will practice massage covering the scalp, front head, occipital area and neck.
Helmet massage BREO	BREO Helmet Massager	Breo helmet will be installed for massaging the head at different defined places.
TENS ear stimulation	TENS ear stimulation	The investigators will use the (Hwato) device that provides electrical pulse at various frequency and intensity. This TENS device is a prototype modified for ear stimulation.
Deep and Slow breathing	Deep and Slow breathing	This intervention is guided by an app that leads to a full respiratory.
Sham Low Laser Therapy	Sham LLT	The investigators will use the same laser pen, but without laser beam.

Primary Outcome Measures

Name	Time	Method
Changes of HRV recording parameters	Changes from baseline HRV parameters at post intervention 15 minutes	The investigators will use the BIOPAC Machine that captures ECG data, signals were sampled at 500 Hz throughout the testing. Recorded data were reviewed and analyzed using AcqKnowledge software version 4.2. The HRV recording parameters include: (1) Very Low Frequency (VLF) (\< 0.04 Hz), (2) Low Frequency (LF) (0.04 - 0.15 Hz), (3) High Frequency (HF) (0.15 to 0.4 Hz), (4) Total Power (TP), which was calculated by summing up all frequency bands, (5) Total Power partial (TPp) (HF + LF), (6) HFnu (normalized unit of HF), (7) Ratio (HF divided by LF).

Secondary Outcome Measures

Name	Time	Method
Change of Heart Rate	Change from baseline heart rate at post intervention 15 minutes	Heart rate will be monitored at the same time of blood pressure
Change of Blood Pressure (Systolic and Diastolic Blood pressure)	Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes	Both systolic and diastolic blood pressure will be recorded by an automated monitoring device (OMROM - HEM 7124) at baseline (after the 5 minutes rest) and at the end of the 15 minutes follow-up.
Change of Body Tension	Change from baseline body tension at post intervention 15 minutes	Body tension is assessed using a a 10-point Likert-scale (the minimum score is 0, and the maximum score is 10)ratings of perceived body tension (BT) as indicator of stress. The highers scores indicate more stress.

Trial Locations

Locations (1)

Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection; 🇨🇳 Beijing, China