Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

N/ACompletedNCT06241911

Liu Yonghong60 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Narcolepsy Type 1 Fmri

Interventions

transcutaneous auricular vagus nerve stimulationDEVICE

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)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires 2. The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126 3. Local residence for more than 3 months 4. Willingness to follow the trial plan as scheduled Exclusion Criteria: 1. History of a clinically defined neurological or sleep disorders other than NT1 2. Any psychiatric disorder involving a history of psychosis 3. Any chronic condition affecting the ability to read or comprehend written instructions 4. Any substances abuse within the past 12 months 5. Pregnant or nursing 6. Metallic implants or devices contraindicating tVNS

Locations (1)

Liu Yonghong

Xi'an, Shaanxi, China

Outcomes

Primary Outcomes

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.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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