Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

Liu Yonghong

Status: Completed

Conditions: Narcolepsy Type 1; Fmri

Treatments: Device: transcutaneous auricular vagus nerve stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06241911

KY20222053-C-1

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

tVNS

Active Comparator group

Description:

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

Treatment:

Device: transcutaneous auricular vagus nerve stimulation

Sham tVNS

Sham Comparator group

Description:

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

Treatment:

Device: transcutaneous auricular vagus nerve stimulation