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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06241911

Enrollment

Registered

2024-02-05

Start date

2022-04-01

Completion date

2024-01-01

Last updated

2024-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fmri, Narcolepsy Type 1

Keywords

transcutaneous auricular vagus nerve stimulation

Brief 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

Interventions

DEVICEtranscutaneous 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
maintenance of wakefulness test (MWT)	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026