An interventional study of taVNS and Mindfulness Meditation in No Condition, sponsored by University of Houston. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by University of Houston · Not applicable, Interventional, and Other
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.
University of Houston is the lead sponsor of 102 studies on the registry; 17 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
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Exclusion Criteria:
30 minutes of moderate intensity transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation
Device: taVNS · Behavioral: Mindfulness Meditation
30 minutes of moderate intensity transauricular vagus nerve stimulation + no audio
Device: taVNS
30 minutes of low intensity transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation
Behavioral: Mindfulness Meditation · Other: low intensity taVNS
30 minutes of low intensity transauricular vagus nerve stimulation + no audio
Other: low intensity taVNS
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.
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.
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.
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)
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)
Plan to share: Yes — Individual participant data will be shared upon reasonable request to the PI (Dr. Chelsea Ratcliff)
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: After publication of findings
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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