Insomnia
Conditions
Interventions
Sponsors
Department of Radiology,The Second Clinical College of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic criteria of chronic insomnia in International Classification of Sleep Disorders (Third Edition): (1) The patient complained that it was difficult to fall asleep or maintain sleep, wake up early, and dissatisfied with sleep quality; (2) Patients with daytime fatigue, sleepiness, impaired attention and memory, emotional instability and prone to irritation; (3) Patients have difficulties in falling asleep and can not be explained simply by poor sleeping environment (such as darkness, safety and comfort); (4) The patient's sleep disorder or related daytime symptoms occured at least 3 times a week and lasted for more than 3 months;E.The cause of insomnia in patients cannot be explained by any other disea. 2. Male or female aged 18 to 70 years old; 3. The patients' symptom scores, "Pittsburgh sleep score" > 7 points, "Insomnia severity index" >14 points, 24 "Hamilton depression score" < 35 points (more than 20 points may have depression, greater than 35 points for severe depression), "Hamilton Anxiety Scale"< 29 points, "Self-evaluation Anxiety Scale(SAS)" standard score< 50 points ", Self-rating Depression Scale (SDS)" standard score< 52 points; 4. The patients agreed to participate in the clinical research and sign the informed consent. They have a certain level of education to cooperate with the the relevant insomnia/anxiety/depression score scale.
Exclusion criteria
Exclusion criteria: 1. Patients with cardiovascular, digestive, liver, kidney, hematopoietic system and other serious primary diseases; patients with diseases that might be in danger through vagal nerve stimulation, such as heart failure, hyperthyroidism. 2. Patients have a history of alcoholism, drug abuse, mental illness or dementia; 3. Patients with allergy, damage or inflammation at the therapeutic site; 4. Pregnant or lactating women; 5. Patients took anticholinergics, non-steroidal anti-inflammatory drugs and hormone drugs recently. Patients are taking anti-depressants to inhibit the activity of the cerebral cortex nervous system currently; 6. There are contraindications of magnetic resonance examination such as metal implants and claustrophobia; 7. Patients participating in other clinical trials in the past six months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diffusion tensor imaging(DTI);Brain functional connectivity;Amplitude of low-frequency fluctuation(ALFF);Regional homogeneity(ReHo);The blood oxygen level dependent(BOLD) ;Brain arterial spin labeling(ASL); | — |
Secondary
| Measure | Time frame |
|---|---|
| 25-hydroxy-vitamin D;Brain-derived neurotrophic factor(BDNF);?-aminobutyric acid (GABA); | — |
Countries
China
Contacts
Public ContactXiaoyan Hou
The Second Clinical College of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Chinese Medicine)
Outcome results
None listed