Fmri Clinical Trial
Official title:
Safety and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1: A Double-blind, Randomized, Sham-controlled Trial
Verified date | January 2024 |
Source | Xijing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
China | Liu Yonghong | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Liu Yonghong |
China,
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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