Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1

Not Applicable

Completed

• Conditions: Narcolepsy Type 1; Fmri
• Interventions: Device: transcutaneous auricular vagus nerve stimulation

• Registration Number: NCT06241911
• Lead Sponsor: Liu Yonghong

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-04-01
• Primary Completion: 2023-10-01
• Study Completion: 2024-01-01
• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-26
• Study First Posted: 2024-02-05
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-23
• Last Update Posted: 2024-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tVNS	transcutaneous auricular vagus nerve stimulation	transcutaneous vagus nerve stimulation on the left earlobe with 25-Hz frequency, with the same stimulation parameters
tVNS	transcutaneous auricular vagus nerve stimulation	transcutaneous vagus nerve stimulation on the left auricle with 25-Hz frequency, with a 30-second on/off cycle.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Liu Yonghong; 🇨🇳 Xi'an, Shaanxi, China