[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621522":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":26},{"fullName":5,"class":6},"University of Malaga","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tVNS","EXPERIMENTAL","Home-based auricular transcutaneous vagus nerve stimulation (tVNS) applied to the left cymba conchae (or tragus if needed) using a low-frequency TENS-like device. Sessions are performed for 60 minutes, 5 days\u002Fweek for 3 weeks. Stimulation intensity is adjusted to a strong but comfortable paresthesia below pain threshold.",[13],"Device: Auricular Transcutaneous Vagus Nerve Stimulation (tVNS)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control (Earlobe Stimulation)","PLACEBO_COMPARATOR","Control stimulation delivered to the ipsilateral earlobe using the same device and schedule as the active intervention (60 minutes, 5 days\u002Fweek for 3 weeks) to mimic sensory stimulation without targeting auricular vagal afferents.",[19],"Device: Sham stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Auricular Transcutaneous Vagus Nerve Stimulation (tVNS)","Home-based auricular transcutaneous vagus nerve stimulation (tVNS) delivered using a low-frequency TENS-like device. Stimulation is applied to the left cymba conchae (or tragus if needed) for 60 minutes per session, 5 sessions per week for 3 weeks. Biphasic symmetrical waveform (25 Hz, 200 μs pulse width). Intensity is individually adjusted to a strong but comfortable paresthesia below pain threshold.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham stimulation","Control stimulation delivered using the same low-frequency TENS-like device and parameters (25 Hz, 200 μs) applied to the ipsilateral earlobe to mimic sensory stimulation. Sessions are performed for 60 minutes per session, 5 sessions per week for 3 weeks, without targeting auricular vagal afferents.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Ismael Romero Garcia, Principal Investigator","CONTACT","0034651789328","iromero@centrosanisidoro.es",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Ismael Romero García","Principal Investigator \u002F PhD Candidate","100621522","home-based-auricular-transcutaneous-vagus-nerve-stimulation-tvns-for-sleep-quality-and-psycho-academic-outcomes-in-health-sciences-students-100621522",false,"NCT07371715","Home-Based Auricular Transcutaneous Vagus Nerve Stimulation (tVNS) for Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students","Efficacy, Safety, and Feasibility of a Home-Based Auricular Transcutaneous Electrical Stimulation Intervention Using a Low-Frequency TENS-Like Device to Improve Sleep Quality and Psycho-Academic Outcomes in Health Sciences Students: A Randomized Controlled Pilot Study","NEUROSLEEP","Inclusion Criteria:\n\n* Aged 18 to 35 years.\n* Undergraduate student enrolled in a Health Sciences degree program.\n* Poor sleep quality defined as PSQI \\> 7.\n* Meets diagnostic criteria for primary insomnia according to ICSD-3.\n* Ability to understand study procedures and provide written informed consent.\n* Willing and able to self-administer the intervention at home and complete study questionnaires.\n\nExclusion Criteria:\n\n* Current severe psychiatric disorder or ongoing psychotherapy treatment.\n* Neurological disorders (e.g., epilepsy).\n* Cardiac arrhythmias or implanted cardiac devices (e.g., pacemaker).\n* Current use of medications that significantly affect sleep (e.g., hypnotics or anxiolytics), unless stable and approved by the investigator.\n* Pregnancy.\n* Ear infection, skin lesions, or dermatologic condition preventing electrode placement.\n* Hypersensitivity or intolerance to electrical stimulation.\n* Participation in another clinical trial within the last 30 days.","ALL","18 Years","35 Years",{"count":53,"type":54},60,"ESTIMATED","INTERVENTIONAL",[57],"NA","This study aims to evaluate the efficacy, safety, and feasibility of a home-based auricular transcutaneous vagus nerve stimulation (tVNS) program in Health Sciences university students with poor sleep quality. Participants will be randomly assigned (1:1) to receive either active auricular stimulation (cymba conchae\u002Ftragus) or a control stimulation applied to the earlobe. The intervention will be self-administered at home using a low-frequency TENS-like device for 60 minutes per session, 5 sessions per week for 3 weeks. Sleep quality will be primarily assessed using the Pittsburgh Sleep Quality Index (PSQI) before and after the intervention. Secondary outcomes include insomnia severity, daytime sleepiness, perceived stress, anxiety, quality of life, and psycho-academic outcomes.",[60,61,62],"Sleep Disturbances","Insomnia","Stress",[64,65,66,67],"Transcutaneous Vagus Nerve Stimulation","sleep quality","Auricular Stimulation","university students","NOT_YET_RECRUITING","2026-01-23",{"date":71,"type":72},"2026-01-28","ACTUAL",{"date":74,"type":54},"2026-03-01",{"date":76,"type":54},"2026-06-01",{"name":5,"class":6}]