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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tVNS | Active Comparator | transcutaneous vagus nerve stimulation on the left auricle with 25-Hz frequency, with a 30-second on/off cycle. |
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| Sham tVNS | Sham Comparator | transcutaneous vagus nerve stimulation on the left earlobe with 25-Hz frequency, with the same stimulation parameters |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcutaneous auricular vagus nerve stimulation | Device | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liu Yonghong | Xi'an | Shaanxi | 710000 | China |
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