Vagus Nerve Stimulation Clinical Trial
Official title:
Multi-device Testing for Autonomic Nervous System Stimulation
NCT number | NCT04341649 |
Other study ID # | 119209 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2019 |
Est. completion date | March 24, 2020 |
Verified date | April 2020 |
Source | Beijing Tiantan Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
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 |
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