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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06241911
Other study ID # KY20222053-C-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 1, 2022
Est. completion date January 1, 2024

Study information

Verified date January 2024
Source Xijing Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 1, 2024
Est. primary completion date October 1, 2023
Accepts healthy volunteers No
Gender All
Age group 12 Years to 60 Years
Eligibility Inclusion Criteria: (1) Clinical diagnosis of narcolepsy type 1; (2) willingness to comply with the scheduled trial plan Exclusion Criteria: (1) the patients with neurological or sleep disorders other than narcolepsy type 1; (2) any substances abuse

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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)

Locations

Country Name City State
China Liu Yonghong Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Liu Yonghong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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