Multi-device Testing for Autonomic Nervous System Stimulation

Capital Medical University

Status: Completed

Conditions: Vagus Nerve Stimulation

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04341649

119209

Details and patient eligibility

About

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.

Full 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)

Enrollment: 15 patients

Sex: All

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 7 patient groups

Head massage by therapist

Active Comparator group

Description:

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

Treatment:

Other: Manual Head Massage

Helmet massage BREO

Active Comparator group

Description:

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

Treatment:

Device: BREO Helmet Massager

Low Laser Therapy

Active Comparator group

Description:

Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng).

Treatment:

Device: Low Laser Therapy (LLT)

Sham Low Laser Therapy

Active Comparator group

Description:

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

Treatment:

Device: Sham LLT

TENS ear stimulation

Active Comparator group

Description:

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.

Treatment:

Device: TENS ear stimulation

Deep and Slow breathing

Active Comparator group

Description:

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

Treatment:

Behavioral: Deep and Slow breathing

Relaxed Reading time

Sham Comparator group

Description:

Participants will read the newspaper in a quiet environment.

Treatment:

Behavioral: Relaxed Reading time