NCT06241911

Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

Safety and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1: A Double-blind, Randomized, Sham-controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Liu Yonghong · Academic / Other
• Sex: All
• Age: 12 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The study aimed to examine the efficacy and safety of tVNS as a complementary approach for NT1 by conducting a double-blind, randomized, sham-controlled trial. The specific objectives of the study were as follows: To evaluate the effects of complementary tVNS on the ability to maintain wakefulness, severity of narcolepsy, mood and quality of life in patients with NT1

Conditions

• Narcolepsy Type 1
• Fmri

Interventions

Type	Name	Description
DEVICE	transcutaneous auricular vagus nerve stimulation	Transcutaneous auricular vagus nerve stimulation (tVNS) is a newly developed treatment for neuromodulation. It offers advantages such as being non-invasive, cost-effective, and not requiring battery changes, unlike invasive vagus nerve stimulation (iVNS). The auricular branch of the vagus nerve, which is the only afferent branch distributed on the surface of the human body, can be directly stimulated to produce effects similar to classic vagus nerve stimulation (VNS)

Timeline

• Start date: 2022-04-01
• Primary completion: 2023-10-01
• Completion: 2024-01-01
• First posted: 2024-02-05
• Last updated: 2024-06-25

Locations

1 site across 1 country: China