Skip to content

Safety, Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients with Narcolepsy Type 1 (TARGET-NT1): A Two-arm, Randomized, Sham-controlled, Proof-of-Concept study

Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients with Narcolepsy Type 1 and Neurofunctional Imaging

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400094550
Enrollment
Unknown
Registered
2024-12-24
Start date
2022-05-27
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

Nacrolepsy type 1

Interventions

tVNS group:The stimulation of tVNS was located in the left auricular concha. The protocol has a pulse width of 500µs, a frequency of 25 hz, and an on/off period of 30 seconds. This stimulation lasted
stVNS group:The stimulation of tVNS was located in the left earlobe. The parameters are the same as tVNS. The protocol has a pulse width of 500µs, the frequency is 25 hz, and the on/off period is 30 s

Sponsors

Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 47 Years

Inclusion 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 NT1; (3)Local residence for more than 3 months; (4)Willingness to follow the trial plan as scheduled

Exclusion criteria

Exclusion criteria: (1)History of neurological disorders or other sleep disorders that may cause daytime sleepiness; (2)Severe psychiatric disorder involving a history of psychosis; (3)Any chronic condition affecting the ability to read or comprehend written instructions; (4)Any ear trauma; (5)Any substances abuse within the past 12 months; (6)Pregnant or nursing; (7)MRI contraindications; (8)Metallic implants or devices contraindicating tVNS

Design outcomes

Primary

MeasureTime frame
Maintenance of Wakefulness test;

Secondary

MeasureTime frame
Narcolepsy Severity Scale;Epworth Sleepiness Scale;14-item Hamilton Anxiety Rating Scale;17-item Hamilton Depression Rating Scale;

Countries

China

Contacts

Public ContactLiuyonghong

Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University

liuyhong@fmmu.edu.cn+86 139 9123 6602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026