No ConditionSYNCNCT07871279
Stimulating Your Nervous System for Calm (SYNC) Study
A study testing taVNS, Mindfulness Meditation and low intensity taVNS in people with No Condition, run by University of Houston at 1 site in United States.
Trial summary
The goal of this feasibility clinical trial is to learn whether a two-week program involving gentle stimulation of the vagus nerve at the ear (taVNS) is practical and acceptable for healthy young adults. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- No Condition
- What is being tested?
- taVNS, Mindfulness Meditation and low intensity taVNS
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years to 29 years old
- fluent in English
- non-pregnant female participants using effective contraception
- participants with baseline Root Mean Square of Successive Differences (RMSSD, a measure of the variation in time between consecutive heartbeats) within 1 SD below the mean identified by Tegenge et al (2020): Women Men Age Bin Mean Mean- 1SD Mean Mean- 1SD 15-19* 73.8 23.3 70.8. 22 20-24 64.7 17.4 57.3 17.2 25-29 58.0 18 52.1 13.3 *Only individuals >18 years old are eligible, but the 15-19 age bin will be used for participants falling in this age range.
Who cannot join
- taking medication for psychiatric, cardiovascular or chronic inflammatory condition (e.g., rheumatoid arthritis)
- used recreational drugs within past 2 weeks
- history of serious mental health conditions (including schizophrenia, other psychotic disorder, bipolar disorder, or severe major depressive disorder), cardiovascular disease, or neurological disease
- skin irritation at stimulation sites
- pregnant women
- engaged in meditation more than 4 times in the past two weeks
Show all 9Show fewer
- adults unable to consent
- prisoners
- students for whom the investigator have direct access to or influence on their grades
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this feasibility clinical trial is to learn whether a two-week program involving gentle stimulation of the vagus nerve at the ear (taVNS) is practical and acceptable for healthy young adults. The study will also evaluate whether collecting information about heart rate patterns and well-being is feasible during the program. If this study is feasible and acceptable, the research team will conduct a larger study to see if taVNS alone or in combination with listening to audio instructions is helpful for individuals in terms of mental and physical health.
- Conditions
- No Condition
- Being tested
- taVNS, Mindfulness Meditation, low intensity taVNS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
taVNSDevice
This study will use the commercially available taVNS device from Parasym (referred to as Auricular Vagal Nerve Treatment (AVNT) device in research contexts and as Nuropod commercially in the United States), a noninvasive external ear stimulation device that delivers low-level electrical stimulation to the auricular branch of the vagus nerve. For those in the moderate intensity taVNS condition, mild electrical impulses at controlled low voltages using a biocompatible reusable electrode will be administered. Participants will come to the lab 5 days/week for 2 weeks (10 sessions) and receive 30 minutes of taVNS.
Mindfulness MeditationBehavioural
For those in the mindfulness meditation (MM) conditions, participants will be presented with an 10- to 15-minute MM audio recording designed to deliver mindfulness training from the Mindfulness Coach app developed by the Veteran Affairs' National Center for PTSD. MM will be delivered in the first 10-15 minutes of each 30-minute taVNS (or sham taVNS) session.
low intensity taVNSOther
This study will use the commercially available taVNS device from Parasym (referred to as Auricular Vagal Nerve Treatment (AVNT) device in research contexts and as Nuropod commercially in the United States), a noninvasive external ear stimulation device that delivers low-level electrical stimulation to the auricular branch of the vagus nerve. For those in the low intensity taVNS condition, a biocompatible reusable electrode will be placed on participant's triages, and low intensity electrical stimulation will be applied. Participants will come to the lab 5 days/week for 2 weeks (10 sessions) and receive 30 minutes of low intensity taVNS.
| Study group | Role | What they receive |
|---|---|---|
| moderate intensity taVNS + Meditation | Experimental | 30 minutes of moderate intensity transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation Receives: Device: taVNS; Behavioral: Mindfulness Meditation |
| moderate intensity taVNS + no audio | Active comparator | 30 minutes of moderate intensity transauricular vagus nerve stimulation + no audio Receives: Device: taVNS |
| low intensity taVNS + meditation | Active comparator | 30 minutes of low intensity transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation Receives: Behavioral: Mindfulness Meditation; Other: low intensity taVNS |
| low intensity taVNS + no audio | Active comparator | 30 minutes of low intensity transauricular vagus nerve stimulation + no audio Receives: Other: low intensity taVNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability
To assess the feasibility and acceptability of the study, the following primary study endpoints will be examined: 1) Retention rate (>70% of consented participants complete follow-up assessment); 2) Adherence rate (>70% of participants complete at least 7 of the 10 sessions); 3) Satisfaction rate (>70% of participants report a satisfaction rating of >7 on a 1-9 Likert satisfaction scale).
Measured: From enrollment to end of intervention period (two weeks post enrollment)
Secondary outcomes (1)
Heart Rate Variability
Root Mean Square of Successive Differences (RMSSD) will be used to assess heart rate variability (HRV)
Measured: From enrollment to end of study (four weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No ConditionStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Factorial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871279
- Sponsor's protocol ID
- STUDY00006100
- Acronym
- SYNC
- Status last verified
- Sep 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data will be shared upon reasonable request to the PI (Dr. Chelsea Ratcliff)
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Your Nervous System for Calm (SYNC) Study
- ClinicalTrials.gov ID
- NCT07871279
- Acronym / sponsor ID
- SYNC / STUDY00006100
- Conditions
- No Condition
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of HoustonUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (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 goal of this feasibility clinical trial is to learn whether a two-week program involving gentle stimulation of the vagus nerve at the ear (taVNS) is practical and acceptable for healthy young adults. The study will also evaluate whether collecting information about heart rate patterns and well-being is feasible during the program. If this study is feasible and acceptable, the research team will conduct a larger study to see if taVNS alone or in combination with listening to audio instructions is helpful for individuals in terms of mental and physical health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Factorial design
| Arm | Type | Receives |
|---|---|---|
| moderate intensity taVNS + Meditation | Experimental | Device: taVNS, Behavioral: Mindfulness Meditation30 minutes of moderate intensity transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation |
| moderate intensity taVNS + no audio | Active comparator | Device: taVNS30 minutes of moderate intensity transauricular vagus nerve stimulation + no audio |
| low intensity taVNS + meditation | Active comparator | Behavioral: Mindfulness Meditation, Other: low intensity taVNS30 minutes of low intensity transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation |
| low intensity taVNS + no audio | Active comparator | Other: low intensity taVNS30 minutes of low intensity transauricular vagus nerve stimulation + no audio |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years to 29 years old
- fluent in English
- non-pregnant female participants using effective contraception
- participants with baseline Root Mean Square of Successive Differences (RMSSD, a measure of the variation in time between consecutive heartbeats) within 1 SD below the mean identified by Tegenge et al (2020): Women Men Age Bin Mean Mean- 1SD Mean Mean- 1SD 15-19* 73.8 23.3 70.8. 22 20-24 64.7 17.4 57.3 17.2 25-29 58.0 18 52.1 13.3 *Only individuals >18 years old are eligible, but the 15-19 age bin will be used for participants falling in this age range.
Key exclusion criteria (9 listed)
- taking medication for psychiatric, cardiovascular or chronic inflammatory condition (e.g., rheumatoid arthritis)
- used recreational drugs within past 2 weeks
- history of serious mental health conditions (including schizophrenia, other psychotic disorder, bipolar disorder, or severe major depressive disorder), cardiovascular disease, or neurological disease
- skin irritation at stimulation sites
- pregnant women
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 |
|---|---|---|
| taVNSThis study will use the commercially available taVNS device from Parasym (referred to as Auricular Vagal Nerve Treatment (AVNT) device in research contexts and as Nuropod commercially in the United States), a noninvasive external ear stimulation device that delivers low-level electrical stimulation to the auricular branch of the vagus nerve. For those in the moderate intensity taVNS condition, mild electrical impulses at controlled low voltages using a biocompatible reusable electrode will be administered. Participants will come to the lab 5 days/week for 2 weeks (10 sessions) and receive 30 minutes of taVNS. | Device | moderate intensity taVNS + Meditation, moderate intensity taVNS + no audio |
| Mindfulness MeditationFor those in the mindfulness meditation (MM) conditions, participants will be presented with an 10- to 15-minute MM audio recording designed to deliver mindfulness training from the Mindfulness Coach app developed by the Veteran Affairs' National Center for PTSD. MM will be delivered in the first 10-15 minutes of each 30-minute taVNS (or sham taVNS) session. | Behavioural | low intensity taVNS + meditation, moderate intensity taVNS + Meditation |
| low intensity taVNSThis study will use the commercially available taVNS device from Parasym (referred to as Auricular Vagal Nerve Treatment (AVNT) device in research contexts and as Nuropod commercially in the United States), a noninvasive external ear stimulation device that delivers low-level electrical stimulation to the auricular branch of the vagus nerve. For those in the low intensity taVNS condition, a biocompatible reusable electrode will be placed on participant's triages, and low intensity electrical stimulation will be applied. Participants will come to the lab 5 days/week for 2 weeks (10 sessions) and receive 30 minutes of low intensity taVNS. | Other | low intensity taVNS + meditation, low intensity taVNS + no audio |
Primary outcome
Feasibility and Acceptability
Time frame: From enrollment to end of intervention period (two weeks post enrollment)
To assess the feasibility and acceptability of the study, the following primary study endpoints will be examined: 1) Retention rate (>70% of consented participants complete follow-up assessment); 2) Adherence rate (>70% of participants complete at least 7 of the 10 sessions); 3) Satisfaction rate (>70% of participants report a satisfaction rating of >7 on a 1-9 Likert satisfaction scale).
1 secondary outcome
Heart Rate Variability
Time frame: From enrollment to end of study (four weeks post-baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data will be shared upon reasonable request to the PI (Dr. Chelsea Ratcliff)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing taVNS, Mindfulness Meditation and low intensity taVNS in people with No Condition, run by University of Houston at 1 site in United States.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Oct 2026. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chelsea G Ratcliff, PhD (713-743-8385, cgratcliff@central.uh.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Acceptability (time frame: From enrollment to end of intervention period (two weeks post enrollment)). 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 16 Oct 2026.