Vagus Nerve StimulationNCT04341649
Multi-device Testing for Autonomic Nervous System Stimulation
A study testing Manual Head Massage, BREO Helmet Massager and Low Laser Therapy (LLT) in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Vagus Nerve Stimulation
- What is being tested?
- Manual Head Massage, BREO Helmet Massager and Low Laser Therapy (LLT)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2019to 24 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers aged 20 to 40 in normal context
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site
Center for Autonomic Evaluation and Brain Plasticity Advanced Innovation Center for Human Brain Protection
Beijing
About this study
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:
Read more
- 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.
Read the 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)
- Conditions
- Vagus Nerve Stimulation
- Being tested
- Manual Head Massage, BREO Helmet Massager, Low Laser Therapy (LLT), Sham LLT, TENS ear stimulation
- Keywords
- Parasympathetic Nervous System, Vagus Nerve Stimulation, Head Massage, Low Laser therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual Head MassageOther
Duration 10 minutes.
BREO Helmet MassagerDevice
Duration 10 minutes.
Low Laser Therapy (LLT)Device
Duration 7 minutes.
Sham LLTDevice
Duration 7 minutes.
TENS ear stimulationDevice
Duration 7 minutes.
Deep and Slow breathingBehavioural
A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.
Relaxed Reading timeBehavioural
Duration 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Head massage by therapist | Active comparator | Head massage therapist will practice massage covering the scalp, front head, occipital area and neck. Receives: Other: Manual Head Massage |
| Helmet massage BREO | Active comparator | Breo helmet will be installed for massaging the head at different defined places. Receives: Device: BREO Helmet Massager |
| Low Laser Therapy | Active comparator | Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng). Receives: Device: Low Laser Therapy (LLT) |
| Sham Low Laser Therapy | Active comparator | The investigators will use the same laser pen, but without laser beam. Receives: Device: Sham LLT |
| TENS ear stimulation | Active comparator | 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. Receives: Device: TENS ear stimulation |
| Deep and Slow breathing | Active comparator | This intervention is guided by an app that leads to a full respiratory. Receives: Behavioral: Deep and Slow breathing |
| Relaxed Reading time | Sham comparator | Participants will read the newspaper in a quiet environment. Receives: Behavioral: Relaxed Reading time |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Changes from baseline HRV parameters at post intervention 15 minutes
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Change from baseline body tension at post intervention 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Apr 2019
- Primary completion23 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vagus Nerve StimulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yilong Wang, Beijing Tiantan Hospital
- Investigators
- Collet Jean-Paul, MD, Phd, Principal investigator, Advanced Innovation Center for Human Brain Protection
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341649
- Sponsor's protocol ID
- 119209
- Status last verified
- Apr 2020
- First submitted
- 25 Mar 2020
- Last updated
- 15 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Need to contact the PI (Dr Collet). Dataset will be transferred with respect of the privacy and confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-device Testing for Autonomic Nervous System Stimulation
- ClinicalTrials.gov ID
- NCT04341649
- Acronym / sponsor ID
- 119209
- Conditions
- Vagus Nerve Stimulation
- Keywords
- Parasympathetic Nervous System, Vagus Nerve Stimulation, Head Massage, Low Laser therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
- 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.
| Arm | Type | Receives |
|---|---|---|
| Head massage by therapist | Active comparator | Other: Manual Head MassageHead massage therapist will practice massage covering the scalp, front head, occipital area and neck. |
| Helmet massage BREO | Active comparator | Device: BREO Helmet MassagerBreo helmet will be installed for massaging the head at different defined places. |
| Low Laser Therapy | Active comparator | Device: Low Laser Therapy (LLT)Laser light can penetrate the skin and stimulate the nervous connections. The investigators will use a laser pen (Min Sheng). |
| Sham Low Laser Therapy | Active comparator | Device: Sham LLTThe investigators will use the same laser pen, but without laser beam. |
| TENS ear stimulation | Active comparator | Device: TENS ear stimulationThe 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. |
| Deep and Slow breathing | Active comparator | Behavioral: Deep and Slow breathingThis intervention is guided by an app that leads to a full respiratory. |
| Relaxed Reading time | Sham comparator | Behavioral: Relaxed Reading timeParticipants will read the newspaper in a quiet environment. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy volunteers aged 20 to 40 in normal context
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manual Head MassageDuration 10 minutes. | Other | Head massage by therapist |
| BREO Helmet MassagerDuration 10 minutes. | Device | Helmet massage BREO |
| Low Laser Therapy (LLT)Duration 7 minutes. | Device | Low Laser Therapy |
| Sham LLTDuration 7 minutes. | Device | Sham Low Laser Therapy |
| TENS ear stimulationDuration 7 minutes. | Device | TENS ear stimulation |
| Deep and Slow breathingA full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration. | Behavioural | Deep and Slow breathing |
| Relaxed Reading timeDuration 10 minutes. | Behavioural | Relaxed Reading time |
Primary outcome
Changes of HRV recording parameters
Time frame: Changes from baseline HRV parameters at post intervention 15 minutes
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).
3 secondary outcomes
Change of Blood Pressure (Systolic and Diastolic Blood pressure)
Time frame: Change from baseline systolic and diastolic blood pressure at post intervention 15 minutes
Change of Heart Rate
Time frame: Change from baseline heart rate at post intervention 15 minutes
Change of Body Tension
Time frame: Change from baseline body tension at post intervention 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2020.
- Individual participant dataSharing planned: Yes. Need to contact the PI (Dr Collet). Dataset will be transferred with respect of the privacy and confidentiality
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Collet Jean-Paul, MD, Phd principal investigator
Advanced Innovation Center for Human Brain Protection
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual Head Massage, BREO Helmet Massager and Low Laser Therapy (LLT) in people with Vagus Nerve Stimulation, run by Beijing Tiantan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of HRV recording parameters (time frame: Changes from baseline HRV parameters at post intervention 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2020.