Nacrolepsy type 1
Conditions
Interventions
bilateral active taVNS group:Bilateral active taVNS group: Electrodes will be placed on the cymba conchae and cavum conchae areas of both ears. Stimulation parameters: pulse width 500 µs, frequency 25
unilateral active taVNS group:Unilateral active taVNS group: Electrodes will be placed on the cymba conchae and cavum conchae areas of both ears. Stimulation parameters: pulse width 500 µs, frequency
sham taVNS group:Sham taVNS group: Electrodes will be placed on the cymba conchae and cavum conchae areas of both ears. Stimulation parameters: pulse width 500 µs, frequency 25 Hz, with alternating bi
Sponsors
Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for NT1 according to ICSD-3-TR; (2) Aged >=18 and <=70 years, capable of accurately describing their symptoms and feelings and completing questionnaires; (3) Symptoms have not been effectively controlled in the past 3 months, with inadequate response to or intolerance of the side effects of standard treatments; (4) Have resided locally for more than 3 months; (5) Willing to comply with the trial protocol, including auricular electrical stimulation and related examinations; (6) Able to ensure no simultaneous participation in other clinical trials or studies that may affect the trial results during the study period; (7) Signed informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of severe neurological disorders, such as stroke, traumatic brain injury, epilepsy, etc.; (2) Presence of other severe sleep disorders, such as severe obstructive sleep apnea-hypopnea syndrome, restless legs syndrome, etc.; (3) Presence of severe internal medical diseases, such as cardiovascular diseases, hepatic or renal failure, malignant tumors, etc.; (4) Presence of severe psychiatric disorders, including major depressive disorder, schizophrenia, or a history of psychotic episodes; (5) Presence of chronic conditions that impair the ability to read or understand written instructions; (6) Use of implantable medical devices, such as cardiac pacemakers; (7) History of drug abuse or alcohol dependence; (8) Pregnant or lactating women; (9) Presence of auricular skin lesions or contraindications to taVNS, such as allergy to electrode materials; (10) Presence of contraindications to MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| epworth sleepiness scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| narcolepsy severity scale;pittsburgh sleep quality index;fatigue severity scale;14-item Hamilton Anxiety Rating Scale;17-item Hamilton Depression Rating Scale (HAMD-17); | — |
Countries
China
Contacts
Public ContactLiu Yonghong
Xijing Hospital, the First Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed