NCT07416708

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

Evaluation of the Transcutaneous Vagal Nerve Stimulation (Auricular Vagal Neuromodulation Therapy) on Cognitive Frailty, Sleep Quality, and Inflammation in Older Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Balnear and Rehabilitation Sanatorium Techirghiol · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Frailty Syndrome
• Dementia

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Vagus Nerve Stimulation	All patients received individual rehabilitation procedures tailored on their musculoskeletal degenerative disease.
PROCEDURE	Physiotherapy	Physiotherapy is a non-invasive treatment used to relieve pain, improve mobility, and speed up recovery after injuries, surgeries, or chronic conditions. It helps restore body functions, improve posture, and prevent relapses.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-05-01
• Completion: 2025-05-15
• First posted: 2026-02-18
• Last updated: 2026-03-04

Locations

1 site across 1 country: Romania