Chronic insomnia
Conditions
Interventions
37? group:37? normal saline is injected into the vagus nerve within the cervical sheath
25? group:25? normal saline is injected into the vagus nerve within the cervical sheath
15? group:15? normal saline is injected into the vagus nerve within the cervical sheath
4? group:4? normal saline is injected into the vagus nerve within the cervical sheath
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.It meets the diagnostic criteria for "chronic insomnia disorder" in the International Classification of Sleep Disorders, 3rd Edition (ICSD-3), with a course of insomnia of >=3 months and insomnia of >=3 times per week; 2.Reduced vagus nerve excitability was confirmed by heart rate variability (HRV) testing: high-frequency power (HF, reflecting vagus nerve activity) < 200 ms², or standardized HF (HFnu) < 30%; Age: 18-65 years old, gender not limited; 3.Sign the informed consent form and voluntarily cooperate to complete the research;
Exclusion criteria
Exclusion criteria: 1.Secondary insomnia (caused by anxiety, depression, sleep apnea syndrome, thyroid dysfunction, etc.); 2.Anatomical abnormalities of the neck (such as tumors, lymph node enlargement), history of vagus nerve injury or surgical history; 3.Severe cardiovascular and cerebrovascular diseases (such as atrial fibrillation and myocardial infarction), and liver and kidney dysfunction; 4.Pregnant or lactating women; 5.People allergic to normal saline;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vagus nerve excitability indicators;PSQI score: Assesses sleep quality (total score 0-21, > 7 indicates insomnia); | — |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory indicators(Cortisol, acetylcholinesterase activity, catecholamines, IL-6);Epworth sleep scale;Polysomnography;Insomnia severity index; | — |
Countries
China
Contacts
Public ContactXiaomin Wu
Zhejiang Provincial People's Hospital
Outcome results
None listed