Safety and Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1: A Double-blind, Randomized, Sham-controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- maintenance of wakefulness test (MWT)
Study Overview
Brief 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 60 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 12 years old with the ability to understand and complete the self-reported questionnaires
- •The patients met the international classification of sleep disorders third edition (ICSD-3) for NT126
- •Local residence for more than 3 months
- •Willingness to follow the trial plan as scheduled
Exclusion Criteria
- •History of a clinically defined neurological or sleep disorders other than NT1
- •Any psychiatric disorder involving a history of psychosis
- •Any chronic condition affecting the ability to read or comprehend written instructions
- •Any substances abuse within the past 12 months
- •Pregnant or nursing
- •Metallic implants or devices contraindicating tVNS
Arms & Interventions
tVNS
transcutaneous vagus nerve stimulation on the left auricle with 25-Hz frequency, with a 30-second on/off cycle.
Intervention: transcutaneous auricular vagus nerve stimulation (Device)
Sham tVNS
transcutaneous vagus nerve stimulation on the left earlobe with 25-Hz frequency, with the same stimulation parameters
Intervention: transcutaneous auricular vagus nerve stimulation (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Liu Yonghong
chief of neurology
Xijing Hospital