An interventional study of Manual Head Massage and BREO Helmet Massager in Vagus Nerve Stimulation, sponsored by Beijing Tiantan Hospital. Completed at 1 site in China. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-15.
Sponsored by Beijing Tiantan Hospital · Not applicable, Interventional, and Treatment
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:
Therefore, within the same design the investigators want to conduct two separate studies that should lead to two separate publications:
The two other interventions: TENS ear stimulation and Deep and Slow breathing are purely observational to gain knowledge in context of a convenient design.
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:
Beijing Tiantan Hospital is the lead sponsor of 481 studies on the registry; 287 are open to participants now.
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Head massage therapist will practice massage covering the scalp, front head, occipital area and neck.
Other: Manual Head Massage
Breo helmet will be installed for massaging the head at different defined places.
Device: BREO Helmet Massager
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)
The investigators will use the same laser pen, but without laser beam.
Device: Sham LLT
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
This intervention is guided by an app that leads to a full respiratory.
Behavioral: Deep and Slow breathing
Participants will read the newspaper in a quiet environment.
Behavioral: Relaxed Reading time
Duration 10 minutes.
Duration 10 minutes.
Duration 7 minutes.
Duration 7 minutes.
Duration 7 minutes.
A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.
Duration 10 minutes.
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).
Time frame: Changes from baseline HRV parameters at post intervention 15 minutes
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.
Time frame: Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes
Change of Heart Rate
Heart rate will be monitored at the same time of blood pressure
Time frame: Change from baseline heart rate at post intervention 15 minutes
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.
Time frame: Change from baseline body tension at post intervention 15 minutes
Plan to share: Yes — Need to contact the PI (Dr Collet). Dataset will be transferred with respect of the privacy and confidentiality
Supporting information: Study protocol
Time frame: About one month
Access criteria: Demand from one academic center
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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