Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

Fmri Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06241911
• Other study ID #: KY20222053-C-1
• Status: Completed
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: January 2024
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

Inclusion Criteria:

(1) Clinical diagnosis of narcolepsy type 1; (2) willingness to comply with the scheduled trial plan Exclusion Criteria: (1) the patients with neurological or sleep disorders other than narcolepsy type 1; (2) any substances abuse

Related Conditions & MeSH terms

• Fmri
• Narcolepsy
• Narcolepsy Type 1

Intervention

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)

Locations

Country	Name	City	State
China	Liu Yonghong	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Liu Yonghong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	maintenance of wakefulness test (MWT)	the changes in the maintenance of wakefulness test (MWT), mean sleep latency of the 4 MTW trials at baseline, week 4, week 8 and week 12, a clinical tool used to objectively measure the ability of patients with NT1 to maintain wakefulness and vigilance.	12 weeks