Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

NCT06241911 | Completed

• 1 other identifier: KY20222053-C-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Narcolepsy Type 1; Fmri

Keywords

transcutaneous auricular vagus nerve stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

tVNS

ACTIVE COMPARATOR

transcutaneous vagus nerve stimulation on the left auricle with 25-Hz frequency, with a 30-second on/off cycle.

Device: transcutaneous auricular vagus nerve stimulation

Sham tVNS

SHAM COMPARATOR

transcutaneous vagus nerve stimulation on the left earlobe with 25-Hz frequency, with the same stimulation parameters

Device: transcutaneous auricular vagus nerve stimulation

Interventions

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)

Sham tVNS; tVNS

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Liu Yonghong: lead

Study Sites (1)

Liu Yonghong

Xi'an, Shaanxi, 710000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: chief of neurology

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: February 5, 2024
• Study Start: April 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: June 25, 2024

Record last verified: 2024-06

Locations

CN (1)