{"type":"trials","record":{"id":31173,"source_id":"clinicaltrials-gov","external_id":"NCT07416708","title":"The Impact of Transcutaneous Vagal Nerve Stimulation on Frailty Syndrome in Older Adults","brief_summary":"This clinical study, conducted at the Techirghiol Balneary and Rehabilitation Sanatorium, aims to evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in improving clinical and biological parameters associated with frailty in older adults. Over a two-week period, participants aged over 60 years, without dementia, cardiac pacemakers, or auditory implants, will be assigned to two groups: an intervention group receiving active taVNS and a control group receiving sham stimulation. Both groups will undergo individualized medical rehabilitation therapies according to their clinical needs. The study will assess frailty using the Edmonton Frailty Scale, sleep quality through the Pittsburgh Sleep Quality Index, and cognitive function with the Montreal Cognitive Assessment (MoCA) and the Rapid Cognitive Screen. Additionally, inflammatory markers (C-reactive protein, IL-6, TNF-alpha) will be measured at baseline and upon discharge. The primary objective is to demonstrate that the intervention group will show greater improvements in cognitive scores, sleep quality, and reductions in inflammatory markers compared to the control group at the end of the study.","overall_status":"Completed","phases":[],"study_type":"INTERVENTIONAL","sponsor":"Balnear and Rehabilitation Sanatorium Techirghiol","enrollment":80,"countries":["Romania"],"start_date":"2024-12-01","completion_date":"2025-05-15","last_update_date":"2026-03-04","source_url":"https://clinicaltrials.gov/study/NCT07416708","editorial_summary":"A registered study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:16:21.317971+00:00","last_seen_at":"2026-09-25T06:10:07.378+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"60 Years to 85 Years","comparator":null,"organization":"Balnear and Rehabilitation Sanatorium Techirghiol","interventions":["Transcutaneous Auricular Vagus Nerve Stimulation","Physiotherapy"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty…","Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality — We performed 2 measurements on day…"],"design_description":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","source_has_results":false},"controlled_terms":["Frailty Syndrome","Dementia","Transcutaneous Auricular Vagus Nerve Stimulation","Physiotherapy"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":85,"publication_state":"published","match_explanation":"Title contains controlled term: frailty.","quality_checked_at":"2026-09-25T06:10:20.034853+00:00","duplicate_cluster_key":"id:nct07416708","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2024-12-01 to 2025-05-15","comparator":null,"confidence":"structured-source","population":"ALL · 60 Years to 85 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:07.458Z","intervention":["Transcutaneous Auricular Vagus Nerve Stimulation","Physiotherapy"],"participants":80,"study_design":"RANDOMIZED · PARALLEL · PREVENTION · SINGLE","subject_scope":"Human clinical study registration","evidence_stage":"Phase not reported","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Evaluation of the transcutaneous vagal nerve stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty…","Effects of AVNT (Trans-auricular vagus nerve stimulation) therapy on sleep quality — We performed 2 measurements on day…"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"frailty","is_published":true,"match_reasons":["Title contains controlled term: frailty.","Abstract contains controlled term: frailty.","Source terminology contains: frailty.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Frailty","slug":"frailty"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/31173","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}