On December 12, 2025, a new clinical trial focusing on vagus nerve stimulation (VNS) was announced, presenting groundbreaking potential to optimize autonomic and cardiovascular functions in healthy individuals. Sponsored by SEFA HAKTAN HATIK and using the Pulsetto FIT™ devices, researchers are examining frequency-dependent effects of auricular VNS on key health metrics like heart rate, blood pressure, and respiration. This study is not yet recruiting, but its implications for medical device innovation and regulatory approval are significant.
In this article:
- Effects of Vagus Nerve Stimulation Explained
- Which Devices Are Being Studied?
- Who Is Sponsoring This Trial and What Is the Timeline?
Effects of Vagus Nerve Stimulation Explained
Auricular vagus nerve stimulation, delivered through targeted electrical devices, has emerged as a promising intervention for regulating autonomic nervous system functions. It can influence cardiovascular metrics such as heart rate, blood pressure, and respiratory pattern, potentially offering benefits in both therapeutic and preventive applications.
Frequency modulation plays a critical role in the effectiveness of VNS. This trial specifically investigates how stimulation frequencies from 10 Hz to 100 Hz impact autonomic and cardiovascular parameters. Such studies could refine the use of VNS for tailored therapeutic interventions.
Which Devices Are Being Studied?
The Pulsetto FIT™ device series serves as the centerpiece of this trial. The study compares five approaches:
- Pulsetto FIT™ – Sham transcutaneous vagus nerve stimulation (tcVNS)
- Pulsetto FIT™ – tcVNS at 10 Hz
- Pulsetto FIT™ – tcVNS at 25 Hz
- Pulsetto FIT™ – tcVNS at 50 Hz
- Pulsetto FIT™ – tcVNS at 100 Hz
By applying VNS across these varying frequencies, researchers aim to identify optimal stimulation practices that influence health outcomes. The study aligns robustly with regulatory demands for device performance and safety evaluations.
Who Is Sponsoring This Trial and What Is the Timeline?
SEFA HAKTAN HATIK is driving this trial with its focus on Pulsetto FIT™ devices. The trial remains in the preparatory phase and is currently labeled “Not yet recruiting” on ClinicalTrials.gov.
Given its scope, the trial may provide essential insights for manufacturers, regulators, and clinical practitioners seeking advancements in non-invasive therapeutic technology for autonomic modulation. Findings will also inform future regulatory submissions and device approval processes.
Frequently Asked Questions
- What is auricular vagus nerve stimulation?
Auricular VNS involves stimulating the vagus nerve at its external location in the ear using a medical device designed for controlled electrical impulses. - What health metrics does VNS impact?
This study focuses on effects on heart rate, blood pressure, and respiration in healthy volunteers. - What are the frequencies being studied?
The trial investigates five frequencies: 10 Hz, 25 Hz, 50 Hz, 100 Hz, alongside a sham device as a control. - When will recruitment begin?
Currently, recruitment has not started as per the trial’s registration on ClinicalTrials.gov.
Conclusion
This clinical trial highlights evolving medical technologies aimed at autonomic control. VNS represents an innovation that might transform therapeutic strategies for cardiovascular modulation and beyond. Health professionals and regulatory experts should closely monitor outcomes to evaluate its impact on device standards and patient care applications.
Disclaimer
This content is intended for informational purposes only and does not constitute legal or regulatory advice. Consult appropriate professionals for specific guidance.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07274332?term=medical+device