Multi-device Testing for Autonomic Nervous System Stimulation

Study Overview
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Brief Summary
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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
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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)

Official Title
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Multi-device Testing for Autonomic Nervous System Stimulation

Conditions
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Vagus Nerve Stimulation

Intervention / Treatment
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* Other: Manual Head Massage
* Device: BREO Helmet Massager
* Device: Low Laser Therapy (LLT)
* Device: Sham LLT
* Device: TENS ear stimulation
* Behavioral: Deep and Slow breathing
* Behavioral: Relaxed Reading time


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: It is a crossover randomized trial where each participant is exposed to one of the 7 types of intervention, allocated randomly. Up to 20 healthy volunteers will be recruited.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Head massage by therapist<br>Head massage therapist will practice massage covering the scalp, front head, occipital area and neck. | Other: Manual Head Massage<br>* Duration 10 minutes.<br>|
| Active Comparator: Helmet massage BREO<br>Breo helmet will be installed for massaging the head at different defined places. | Device: BREO Helmet Massager<br>* Duration 10 minutes.<br>|
| Active Comparator: Low Laser Therapy<br>Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng). | Device: Low Laser Therapy (LLT)<br>* Duration 7 minutes.<br>|
| Active Comparator: Sham Low Laser Therapy<br>The investigators will use the same laser pen, but without laser beam. | Device: Sham LLT<br>* Duration 7 minutes.<br>|
| Active Comparator: TENS ear stimulation<br>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. | Device: TENS ear stimulation<br>* Duration 7 minutes.<br>|
| Active Comparator: Deep and Slow breathing<br>This intervention is guided by an app that leads to a full respiratory. | Behavioral: Deep and Slow breathing<br>* A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.<br>|
| Sham Comparator: Relaxed Reading time<br>Participants will read the newspaper in a quiet environment. | Behavioral: Relaxed Reading time<br>* Duration 10 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of HRV recording parameters | 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). | Changes from baseline HRV parameters at post intervention 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Blood Pressure (Systolic and Diastolic Blood pressure) | 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 from baseline systolic and diastolic blood pressure at post intervention 15 minutes | 
| Change of Heart Rate | Heart rate will be monitored at the same time of blood pressure | Change from baseline heart rate at post intervention 15 minutes | 
| Change of Body Tension | 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. | Change from baseline body tension at post intervention 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parasympathetic Nervous System, Vagus Nerve Stimulation, Head Massage, Low Laser therapy