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Completed

NCT Number: NCT04341649

Multi-device Testing for Autonomic Nervous System Stimulation

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.

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Key information

Conditions

Vagus Nerve Stimulation

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection

Beijing, China

About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Manual Head Massage

Other

Duration 10 minutes.

BREO Helmet Massager

Device

Duration 10 minutes.

Low Laser Therapy (LLT)

Device

Duration 7 minutes.

Sham LLT

Device

Duration 7 minutes.

TENS ear stimulation

Device

Duration 7 minutes.

Deep and Slow breathing

Behavioral

A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.

Relaxed Reading time

Behavioral

Duration 10 minutes.

Primary outcomes

  1. Changes of HRV recording parameters

    Time frame: 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 outcomes

  1. Change of Blood Pressure (Systolic and Diastolic Blood pressure)

    Time frame: 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.

  2. Change of Heart Rate

    Time frame: Change from baseline heart rate at post intervention 15 minutes

    Heart rate will be monitored at the same time of blood pressure

  3. Change of Body Tension

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Tiantan Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 10, 2020
Registry last updated
Apr 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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