- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06241911
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1
January 26, 2024 updated by: Liu Yonghong
Safety and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1: A Double-blind, Randomized, Sham-controlled Trial
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shaanxi
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Xi'an, Shaanxi, China, 710000
- Liu Yonghong
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Transcutaneous auricular vagus nerve stimulation
The tVNS protocol consisted of a 500-µs pulse width and 25-Hz frequency, with a 30-second on/off cycle.
The stimulation was applied for a total of 2 hours per day, divided into four 30-minute periods.
At least one of these periods occurred within 2 hours before bedtime.The stimulation point was only limited to the left auricular concha.
|
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)
|
Sham Comparator: sham Transcutaneous auricular vagus nerve stimulation
The same stimulation parameters were used for stVNS, but the stimulation point was the left earlobe.
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
maintenance of wakefulness test (MWT)
Time Frame: 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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2022
Primary Completion (Actual)
October 1, 2023
Study Completion (Actual)
January 1, 2024
Study Registration Dates
First Submitted
January 16, 2024
First Submitted That Met QC Criteria
January 26, 2024
First Posted (Actual)
February 5, 2024
Study Record Updates
Last Update Posted (Actual)
February 5, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20222053-C-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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