A Multicenter Randomized Controlled Study of Pulse Magnetotherapy Combined Medication in the Treatment of Patients With Anxiety Disorder and Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Insomnia Severity Index (ISI)
研究概览
简要总结
The goal of this clinical trial is to explore the therapeutic effect of pulse magnetic therapy system combined with drug therapy on patients with anxiety and insomnia. The main questions it aims to answer are:
- Whether the pulse magnetic therapy system is benefit on improving insomnia in anxiety patients.
- This improvement is not due to the placement of the instrument。 Participants will accept pulse magnetic therapy (stimulation/sham stimulation) and accept scale evaluation before and after treatment.
Researchers will compare the pulse magnetic stimulation group, sham stimulation group and healthy controls to see if the pulse magnetic stimulation do effect on insomnia of anxiety patients.
详细描述
Insomnia is the most common symptom of anxiety disorder, which has an important impact on the prognosis of anxiety. Pulse magnetic therapy system, with its advantages of compact, convenient, easy to carry, and not limited by the scene and time, has gradually become a common tool for sleep monitoring and treatment. This study is a multicenter randomized controlled design, including 150 cases in the pulse magnetic stimulation+drug treatment group, 150 cases in the sham pulse magnetic stimulation+drug treatment group and 100 healthy controls. Before and after treatment, the patients were comprehensively measured and evaluated with Insomnia Severity Index (ISI), Hamilton Depression Rating Scale 17 (HAMD), Hamilton Anxiety Rating Scale (HAMA), Pittsburgh Sleep Quality Index (PSQI), Self-Rating Sleep Scale (SSRS), Self-Rating Symptom Scale 90 (SCL-90), Quality of Life Scale (SF-36), and Treatment Adverse Reaction Scale (TESS), and sleep monitoring was conducted at the same time, To explore the therapeutic effect of pulse magnetic therapy system detector combined with drug therapy on patients with anxiety and insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who met the diagnostic criteria for anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders (Fifth edition; DSM-5) and were accompanied by insomnia with 14 <HAMA<21 , HAMD<17 , and PSQI>7 ;
- •Education level is unlimited;
- •Age: 18-55 years old.
排除标准
- •Have bipolar disorder, schizophrenia, depression and other mental diseases;
- •Have a clear history of head trauma, alcoholism, brain tumors, diabetes, hypertension, and serious primary heart, liver, kidney, and blood system diseases;
- •At present, patients with sleep disorders are being treated by other means besides drugs;
- •Pregnant and lactating women;
- •Have a history of seizures or strong positive family history of epilepsy;
- •Implantation of cardiac pacemaker;
- •Those receiving deep brain stimulation treatment;
- •There are metal or magnetic implants in the body (including but not limited to the brain);
- •Participated in clinical trials of other drugs and medical devices in recent 3 months;
- •Other researchers believe that they do not meet the conditions for inclusion.
研究组 & 干预措施
Pulse Magnetotherapy+medication group
150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs
干预措施: Pulse magnetic therapy (Device)
Pulse Magnetotherapy+medication group
150 patients with anxiety disorder and insomnia who met the inclusion criteria received pulse magnetic therapy and conventional antianxiety drugs
干预措施: Selective serotonin reuptake inhibitors （SSRI） (Drug)
medication group
150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs
干预措施: Selective serotonin reuptake inhibitors （SSRI） (Drug)
medication group
150 patients with anxiety disorder and insomnia who met the inclusion criteria received sham magnetic therapy and conventional antianxiety drugs
干预措施: Shame magnetic therapy (Device)
Healthy control
100 healthy controls who met the inclusion criteria received sham magnetic therapy
干预措施: Shame magnetic therapy (Device)
结局指标
主要结局
Insomnia Severity Index (ISI)
时间窗: Change value of insomnia severity index (ISI) from baseline in the fourth week of intervention
Insomnia Severity Index total score reduction\>50%, the range of Insomnia Severity Index total score is 0-28.
次要结局
未报告次要终点