Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

NCT ID: NCT06241911

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-01-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

tVNS

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

Group Type: ACTIVE_COMPARATOR

transcutaneous auricular vagus nerve stimulation

Intervention Type: 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

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

Group Type: SHAM_COMPARATOR

transcutaneous auricular vagus nerve stimulation

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Liu Yonghong

OTHER

Sponsor Role: lead

Responsible Party

Liu Yonghong

chief of neurology

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Liu Yonghong

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

KY20222053-C-1

Identifier Type: -

Identifier Source: org_study_id