Vagus Nerve Stimulation
Conditions
Keywords
Parasympathetic Nervous System, Vagus Nerve Stimulation, Head Massage, Low Laser therapy
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)
Interventions
OTHERManual Head Massage
Duration 10 minutes.
DEVICEBREO Helmet Massager
Duration 10 minutes.
DEVICELow Laser Therapy (LLT)
Duration 7 minutes.
DEVICESham LLT
Duration 7 minutes.
DEVICETENS ear stimulation
Duration 7 minutes.
BEHAVIORALDeep and Slow breathing
A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.
BEHAVIORALRelaxed Reading time
Duration 10 minutes.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
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
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
Countries
China
Outcome results
None listed