The Impact of Transcutaneous Vagal Nerve Stimulation on Frailty Syndrome in Older Adults

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.

NCT Number	NCT07416708
Lead Sponsor	Balnear and Rehabilitation Sanatorium Techirghiol
Conditions	Frailty Syndrome, Dementia
Enrollment	80 participants
Start Date	2024-12-01
Primary Completion	2025-05-01 (estimated)
Study Completion	2025-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-04