[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659918":3},{"organization":4,"outcomesModule":7,"designInfo":19,"detailedDescription":18,"studyPopulation":18,"armGroups":27,"interventions":50,"overallOfficials":18,"centralContacts":65,"locations":71,"responsibleParty":84,"collaborators":18,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":93,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":18,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":18,"overallStatus":106,"whyStopped":18,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"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).","From enrollment to end of intervention period (two weeks post enrollment)",[14],{"measure":15,"description":16,"timeFrame":17},"Heart Rate Variability","Root Mean Square of Successive Differences (RMSSD) will be used to assess heart rate variability (HRV)","From enrollment to end of study (four weeks post-baseline)",null,{"allocation":20,"interventionModel":21,"interventionModelDescription":22,"primaryPurpose":6,"observationalModel":18,"timePerspective":18,"maskingInfo":23},"RANDOMIZED","PARALLEL","Factorial design",{"masking":24,"maskingDescription":18,"whoMasked":25},"SINGLE",[26],"PARTICIPANT",[28,35,40,45],{"label":29,"type":30,"description":31,"interventionNames":32},"taVNS + Meditation","EXPERIMENTAL","30 minutes of transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation",[33,34],"Device: taVNS","Behavioral: Mindfulness Meditation",{"label":36,"type":37,"description":38,"interventionNames":39},"taVNS + no audio","ACTIVE_COMPARATOR","30 minutes of transauricular vagus nerve stimulation + no audio",[33],{"label":41,"type":37,"description":42,"interventionNames":43},"sham taVNS + meditation","30 minutes of sham transauricular vagus nerve stimulation + 10-15 minutes listening to an audio-guided mindfulness meditation",[34,44],"Other: sham taVNS",{"label":46,"type":47,"description":48,"interventionNames":49},"sham taVNS + no audio","SHAM_COMPARATOR","30 minutes of sham transauricular vagus nerve stimulation + no audio",[44],[51,56,61],{"type":52,"name":53,"description":54,"armGroupLabels":55,"otherNames":18},"DEVICE","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 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\u002Fweek for 2 weeks (10 sessions) and receive 30 minutes of taVNS.",[29,36],{"type":57,"name":58,"description":59,"armGroupLabels":60,"otherNames":18},"BEHAVIORAL","Mindfulness Meditation","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.",[41,29],{"type":6,"name":62,"description":63,"armGroupLabels":64,"otherNames":18},"sham 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 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\u002Fweek for 2 weeks (10 sessions) and receive 30 minutes of sham taVNS.",[41,46],[66],{"name":67,"role":68,"phone":69,"phoneExt":18,"email":70},"Chelsea G Ratcliff, PhD","CONTACT","713-743-8385","cgratcliff@central.uh.edu",[72],{"facility":5,"status":18,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":18},"Houston","Texas","77204","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-95.36327,29.76328,{"lat":82,"lon":81},{"type":85,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100659918","stimulating-your-nervous-system-for-calm-sync-study-100659918",false,"NCT07871279","Stimulating Your Nervous System for Calm (SYNC) Study","SYNC","Inclusion Criteria:\n\n1. 18 years to 29 years old\n2. fluent in English\n3. non-pregnant female participants using effective contraception\n4. 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.\n\nExclusion Criteria:\n\n1\\) taking medication for psychiatric, cardiovascular or chronic inflammatory condition (e.g., rheumatoid arthritis); 2) used recreational drugs within past 2 weeks; 3) history of serious mental health conditions (including schizophrenia, other psychotic disorder, bipolar disorder, or severe major depressive disorder), cardiovascular disease, or neurological disease; 4) skin irritation at stimulation sites; 5) pregnant women; 6) engaged in meditation more than 4 times in the past two weeks; 7) adults unable to consent; 8) prisoners; and 9) students for whom the investigator have direct access to or influence on their grades",true,"ALL","18 Years","29 Years",{"count":98,"type":99},50,"ESTIMATED","INTERVENTIONAL",[102],"NA","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.",[105],"No Condition","NOT_YET_RECRUITING","2026-10-06",{"date":109,"type":110},"2026-10-13","ACTUAL",{"date":112,"type":99},"2026-10-15",{"date":114,"type":99},"2027-12-31",{"name":5,"class":6},1]