Stimulating Your Nervous System for Calm (SYNC) Study

Part of paid clinical trials in Houston, Texas.

Sponsor
University of Houston
Study ID
NCT07871279
Status
Not Yet Recruiting

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Conditions

  • No Condition

Eligibility Criteria

Sex
ALL
Age
18 Years - 29 Years
Healthy Volunteers
Accepted

Interventions

  • 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
    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.

Study Details

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.

Key Dates

First listed
Oct 13, 2026
Start date
Oct 15, 2026
Status verified
Sep 2026
Primary completion
Dec 15, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: taVNS + Meditation
    30 minutes of transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation
  • Active Comparator: taVNS + no audio
    30 minutes of transauricular vagus nerve stimulation + no audio
  • Active Comparator: sham taVNS + meditation
    30 minutes of sham transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation
  • Sham Comparator: sham taVNS + no audio
    30 minutes of sham transauricular vagus nerve stimulation + no audio

Primary Outcome Measure

Feasibility and Acceptability [ Time Frame: From enrollment to end of intervention period (two weeks post enrollment) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of HoustonHoustonTexas77204-

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By research site
University of Houston· Houston, TX

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