ITMCTR1900002284招募中1 期
Research for the central nervous regulation mechanism of transcutaneous auricular vagus nerve stimulation in the treatment of patients with chronic insomnia based on fMRI
Department of Radiology,The Second Clinical College of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Chinese Medicine)0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 70（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
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