insomnia
Conditions
Interventions
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age between 18 and 70 years, gender unrestricted; 2. Patients who meet the diagnostic criteria for persistent insomnia (able to cooperate with SCG treatment and symptom assessment): Meet the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR (DSM-IV) and the Classification and Diagnostic Criteria for Mental Disorders in China, including difficulties in initiating sleep, maintaining sleep, or returning to sleep after early waking, occurring >=3 times per week, with a duration of more than 3 months. Pittsburgh Sleep Quality Index (PSQI) score >7, Insomnia Severity Index (ISI) score >=22; 3. Patients who continue to experience insomnia after long-term use of first-line Western medications (such as benzodiazepines, antidepressants) or other physical therapies and traditional Chinese medicine; 4. Patients who experience side effects or other issues from the above standard treatments.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Insomnia caused by other mental disorders (such as significant psychological trauma); 2. Patients with restless leg syndrome or other neurodegenerative diseases identified through clinical history, physical examination, or routine laboratory tests; 3. History of cerebrovascular accidents, including transient ischemic attacks or strokes, with insomnia occurring within the past 6 months. 4. Long-term use of anticoagulants that cannot be discontinued. Patients with coagulopathy; 5. Patients with cognitive dysfunction or those unable to cooperate in completing assessments or treatments; 6. History of severe head trauma or epilepsy; 7. Patients with severely impaired cardiac function, including but not limited to: unstable angina, myocardial infarction (within 6 months prior to enrollment), congestive heart failure (NYHA >= Class III), severe ventricular arrhythmias; 8. Patients with concurrent malignant tumors; 9. Patients with concurrent glaucoma or thyroid enlargement; 10. Patients with other conditions requiring long-term oxygen therapy, such as sleep apnea; 11. Patients with neck infections or skin lesions; 12. Liver or kidney dysfunction, or other severe and/or uncontrolled comorbidities that may affect the study assessment; 13. Patients with severe orthostatic hypotension; 14. History of substance abuse involving psychoactive drugs or alcohol that has not been resolved, or a history of mental disorders; 15. Allergies to lidocaine or a history of severe allergies; 16. Pregnant or breastfeeding women; 17. Individuals with implanted electronic devices or metal implants; 18. Patients with other diseases deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep-related scales; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Scale;Hamilton Anxiety Scale;Activity of neurotransmitters related to sleep;Sleep parameters related to polysomnography;TMS Cortical Excitability-Related Examination Indicators; | — |
Countries
China
Contacts
Public ContactWei Zhang
Department of Neurology, Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed