Multi-device Testing for Autonomic Nervous System Stimulation

NCT04341649 | Completed DMC

• 1 other identifier: 119209
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Vagus Nerve Stimulation

Keywords

Parasympathetic Nervous System; Vagus Nerve Stimulation; Head Massage; Low Laser therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change of Blood Pressure (Systolic and Diastolic Blood pressure)

  Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes

• Change of Heart Rate

  Change from baseline heart rate at post intervention 15 minutes

• Change of Body Tension

  Change from baseline body tension at post intervention 15 minutes

Study Arms (7)

Head massage by therapist

ACTIVE COMPARATOR

Head massage therapist will practice massage covering the scalp, front head, occipital area and neck.

Other: Manual Head Massage

Helmet massage BREO

ACTIVE COMPARATOR

Breo helmet will be installed for massaging the head at different defined places.

Device: BREO Helmet Massager

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).

Device: Low Laser Therapy (LLT)

Sham Low Laser Therapy

ACTIVE COMPARATOR

The investigators will use the same laser pen, but without laser beam.

Device: Sham LLT

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.

Device: TENS ear stimulation

Deep and Slow breathing

ACTIVE COMPARATOR

This intervention is guided by an app that leads to a full respiratory.

Behavioral: Deep and Slow breathing

Relaxed Reading time

SHAM COMPARATOR

Participants will read the newspaper in a quiet environment.

Behavioral: Relaxed Reading time

Interventions

Manual Head Massage OTHER

Duration 10 minutes.

Head massage by therapist

BREO Helmet Massager DEVICE

Duration 10 minutes.

Helmet massage BREO

Low Laser Therapy (LLT) DEVICE

Duration 7 minutes.

Low Laser Therapy

Sham LLT DEVICE

Duration 7 minutes.

Sham Low Laser Therapy

TENS ear stimulation DEVICE

Duration 7 minutes.

TENS ear stimulation

Deep and Slow breathing BEHAVIORAL

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

Deep and Slow breathing

Relaxed Reading time BEHAVIORAL

Duration 10 minutes.

Relaxed Reading time

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers aged 20 to 40 in normal context

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

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

Beijing, China

Location

MeSH Terms

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Collet Jean-Paul, MD, Phd

  Advanced Innovation Center for Human Brain Protection

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 25, 2020
• First Posted: April 10, 2020
• Study Start: April 1, 2019
• Primary Completion: March 23, 2020
• Study Completion: March 24, 2020
• Last Updated: April 15, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: About one month
• Access Criteria: Demand from one academic center

Locations

CN (1)