Clinical trial NCT04341649: Multi-device Testing for Autonomic Nervous System Stimulation
Official title: Multi-device Testing for Autonomic Nervous System Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vagus Nerve Stimulation
Keywords: Parasympathetic Nervous System
Vagus Nerve Stimulation
Head Massage
Low Laser therapy
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2020-04-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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)

Eligibility criteria: 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

Primary outcomes:
measure: Changes of HRV recording parameters
timeFrame: Changes from baseline HRV parameters at post intervention 15 minutes
Secondary outcomes:
measure: Change of Blood Pressure (Systolic and Diastolic Blood pressure)
timeFrame: Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes
measure: Change of Heart Rate
timeFrame: Change from baseline heart rate at post intervention 15 minutes
measure: Change of Body Tension
timeFrame: Change from baseline body tension at post intervention 15 minutes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection
Study officials:
affiliation: Advanced Innovation Center for Human Brain Protection
name: Collet Jean-Paul, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References: