insomnia
Conditions
Interventions
Treatment group:Stimulate bilateral ear acupoints - vagus nerve distribution area
control subjects:Stimulation of bilateral non-auricular points - vagus nerve distribution areas
Sponsors
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
13 Years to 17 Years
Inclusion criteria
Inclusion criteria: 1Those who meet the diagnostic criteria of insomnia in China Insomnia Disorder Diagnosis and Treatment Guidelines 2019; 2Age: 13-17 years old; gender is not limited; 3, Pittsburgh Sleep Quality Index Rating Scale (PSQI) score =7; 4Obtaining informed consent and signing the informed consent form; 5, able to strictly comply with the treatment requirements 6No diseases of internal organs and immunity, blood system and other serious diseases, no mental illness; 7, not taking benzodiazepines, melatonin and other related drugs within 1~3 weeks before screening (according to the elimination half-life).
Exclusion criteria
Exclusion criteria: 1. Patients who do not meet the inclusion criteria and are mistakenly included; 2. Under 13 years old but over 17 years old; 3. Insomnia with a history of head trauma, other neurological disorders, and other objective environmental factors; 4. Patients with severe primary diseases such as digestive, hematopoietic, and endocrine system tumors; Patients with contraindications to vagus nerve stimulation, such as heart failure and hyperthyroidism; 5. Patient PSQI score<7 points; 6. Have a history of drug abuse or alcohol abuse; 7. Skin allergy, damage or inflammation in the area of auricle treatment; Pregnant or preparing pregnant women, lactating women; 8. Participated in other clinical trials in the past six months; Patients who have recently taken anticholinergic or steroid drugs; Or patients who are currently taking drugs that inhibit the cerebral cortex or nervous system irregularly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index Score (PSQI) Adolescent Sleep Hygiene Habits Scale (ASHS) Adolescent Sleep Assessment Questionnaire (DSM);Adolescent Sleep Hygiene Practices Scale;Adolescent Sleep Assessment Questionnaire; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Assessment Scale for Anxiety (SAS) Self-Depression Scale (SDS) Quality of Life Scale (SF-36) Composite Autonomic Score (COMPASS-31);Depression Self-Rating Scale;Quality of Life Scale;Composite autonomic score; | — |
Countries
China
Contacts
Public ContactDu Junying
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed