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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:
Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications:
The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head massage by therapist | Active Comparator | Head massage therapist will practice massage covering the scalp, front head, occipital area and neck. |
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| Helmet massage BREO | Active Comparator | Breo helmet will be installed for massaging the head at different defined places. |
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| Low Laser Therapy | Active Comparator | Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng). |
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| Sham Low Laser Therapy | Active Comparator | The investigators will use the same laser pen, but without laser beam. |
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| TENS ear stimulation | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Manual Head Massage | Other | Duration 10 minutes. |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Collet Jean-Paul, MD, Phd | Advanced Innovation Center for Human Brain Protection | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection | Beijing | China |
Need to contact the PI (Dr Collet). Dataset will be transferred with respect of the privacy and confidentiality
About one month
Demand from one academic center
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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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.
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Participants may be aware partially or totally of the nature of the intervention. For instance Manual Head Massage or Helmet Massager cannot be blind. However, for LLT or sham LLT the participants will remain blind. Indeed, Relaxed reading time is known by the participants
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| Deep and Slow breathing |
| Active Comparator |
This intervention is guided by an app that leads to a full respiratory. |
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| Relaxed Reading time | Sham Comparator | Participants will read the newspaper in a quiet environment. |
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| BREO Helmet Massager |
| Device |
Duration 10 minutes. |
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| Low Laser Therapy (LLT) | Device | Duration 7 minutes. |
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| Sham LLT | Device | Duration 7 minutes. |
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| TENS ear stimulation | Device | Duration 7 minutes. |
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| Deep and Slow breathing | Behavioral | A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration. |
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| Relaxed Reading time | Behavioral | Duration 10 minutes. |
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| 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 |