Multi-device Testing for Autonomic Nervous System Stimulation

Vagus Nerve Stimulation Clinical Trial

Official title:

Multi-device Testing for Autonomic Nervous System Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04341649
• Other study ID #: 119209
• Status: Completed
• Phase: N/A
• Start date: April 1, 2019
• Est. completion date: March 24, 2020

Study information

• Verified date: April 2020
• Source: Beijing Tiantan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 24, 2020
• Est. primary completion date: March 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Vagus Nerve Stimulation

Intervention

Other:
• Manual Head Massage
Duration 10 minutes.

Device:
• BREO Helmet Massager
Duration 10 minutes.
• Low Laser Therapy (LLT)
Duration 7 minutes.
• Sham LLT
Duration 7 minutes.
• TENS ear stimulation
Duration 7 minutes.

Behavioral:
• Deep and Slow breathing
A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.
• Relaxed Reading time
Duration 10 minutes.

Locations

Country	Name	City	State
China	Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tiantan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change of Blood Pressure (Systolic and Diastolic Blood pressure)	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 from baseline systolic and diastolic blood pressure at post intervention 15 minutes
Secondary	Change of Heart Rate	Heart rate will be monitored at the same time of blood pressure	Change from baseline heart rate at post intervention 15 minutes
Secondary	Change of Body Tension	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.	Change from baseline body tension at post intervention 15 minutes