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Effects of Transcutaneous Vagus Nerve Stimulation in Older Adults

NCT07292623 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-02

No results posted yet for this study

Summary

The autonomic nervous system consists of two branches, the sympathetic and the parasympathetic, which must work in balance. Its functioning can be measured indirectly by heart rate variability, which is the time between heartbeats, which is not constant. The more it varies, the greater the role of the parasympathetic branch, and vice versa. However, with age, an imbalance can occur and the parasympathetic branch can play a lesser role, resulting in less heart rate variability (the times between heartbeats become more similar).

The aim of this study is to know if electrical stimulation in the ear can improve the balance between the two branches of the autonomic nervous system in older adults, comparing two different locations of application. The main questions to answer are:

Does applying electrical stimulation to a specific area of the ear improve the balance of the autonomic nervous system? Does it also help improve hand tremors, balance, concentration, saliva production, and voice quality?

Conditions

  • Older Adults Without Any Specific Clinical Condition
  • Autonomic Nervous System Imbalance
  • Transcutaneous Vagus Nerve Stimulation

Interventions

DEVICE

Active location tVNS

The tVNS will be performed at 20 Hz and 200 microseconds, in the area innervated by the auricular branch of the vagus nerve (cymba concha and concha) in the active location. The intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort. The TENS will be set to 27 seconds of working time, with a 3-second ramp-up and 90 seconds off. It will last until the end of the last HRV test.

DEVICE

Sham Comparator

The tVNS will be performed at 20 Hz and 200 microseconds, in the area not innervated by by the auricular branch of the vagus nerve (scapha) for sham TENS. The intensity will be set above the sensory threshold (intense tingling sensation) but below the level of discomfort. The TENS will be set to 27 seconds of working time, with a 3-second ramp-up and 90 seconds off. It will last until the end of the last HRV test.

Sponsors & Collaborators

  • Universidade da Coruña

    lead OTHER

Principal Investigators

  • Alicia Martínez-Rodríguez, Lecturer · Universidade da Coruña (University of A Coruna)

  • Olalla Bello, Lecturer · Universidade da Coruña (University of A Coruna)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
65 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-19
Primary Completion
2026-02-10
Completion
2026-02-12

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07292623 on ClinicalTrials.gov