Stimulating Your Nervous System for Calm (SYNC) Study

ConditionNo Condition

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-29

SponsorUniversity of Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

taVNS
Device
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 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 Meditation
Behavioral
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.
sham taVNS
Other intervention
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 sham taVNS condition, a biocompatible reusable electrode will be placed on participant's triages, but no electrical stimulation will be applied. Participants will come to the lab 5 days/week for 2 weeks (10 sessions) and receive 30 minutes of sham taVNS.

Treatment groups

50 Participants

are divided into 4 treatment groups

Group A: taVNS + MeditationExperimental treatment 2 interventions

Group B: taVNS + no audioActive comparator 1 intervention

Group C: sham taVNS + meditationActive comparator 2 interventions

Group D: sham taVNS + no audioSham comparator 1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

From enrollment to end of intervention period (two weeks post enrollment)

Secondary outcomes

Heart Rate Variability

Root Mean Square of Successive Differences (RMSSD) will be used to assess heart rate variability (HRV)

Time frame

From enrollment to end of study (four weeks post-baseline)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Houston

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: