Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Narcolepsy Type 1 fMRI

Age range

12 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liu Yonghong

Xi'an, Shaanxi, 710000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires
The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126
Local residence for more than 3 months
Willingness to follow the trial plan as scheduled

Exclusion criteria

History of a clinically defined neurological or sleep disorders other than NT1
Any psychiatric disorder involving a history of psychosis
Any chronic condition affecting the ability to read or comprehend written instructions
Any substances abuse within the past 12 months
Pregnant or nursing
Metallic implants or devices contraindicating tVNS

Treatment and study plan

Transcutaneous Auricular Vagus Nerve Stimulation

Device

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)

Primary outcomes

maintenance of wakefulness test (MWT)

Time frame: 12 weeks

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.

Sponsors and collaborators

Lead sponsor

Liu Yonghong

Other

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2024
First posted: Feb 5, 2024
Registry last updated: Jun 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed