Sleep Improvement of Schumann Resonance in the Treatment of Insomnia-A Randomized and Double-blinded Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- actigraphy
研究概览
简要总结
The double-blinded and randomized study evaluated the effectiveness and side effects of a novel non-invasive treatment, Schumann resonance (SR), in treating insomnia. The objective of this study is (1) to evaluate the improvement of sleep quality of patients with insomnia disorder by SR and (2) to be the basis for the future development of physical magnetic therapy.
详细描述
Insomnia is a common sleep disturbance that affects the health and quality of life of individuals and accounts for considerable utilization of medical resources. The prevalence of insomnia is approximately 30%; in Asia, the prevalence of insomnia is approximately 4% in Japan, 9.9% in South Korea, 10.3% in Taiwan. Based on the statistic of Taiwan BNHI office in a 2013 report, there is worth of 1.3 billion prescriptions of hypnotic drug in one year. In addition, the reimbursement expenditure pays up more than 1 billion New Taiwan Dollars (NTD) with increasing expense rate of 15% every year, showing insomnia causes great distress to Taiwanese.
The characteristics of insomnia are difficulty with initiating or maintaining sleep, early morning waking, or non-restorative sleep. In DSM-5, the diagnosis of primary insomnia has been renamed insomnia disorder to avoid the differentiation between primary and secondary insomnia.
The most common treatment for insomnia is pharmacological therapy with hypnotics such as a benzodiazepine, zolpidem, or zopiclone. However, treatment with hypnotics includes the risk of adverse effects, drug tolerance and dependence . Some past reports on different non-pharmacological treatment strategies, such as Cognitive-Behavioral Therapy (CBT), muscle relaxation training, stimulus control, sleep restriction, and sleep hygiene, have demonstrated the effectiveness of most of these non-pharmacological treatments. However, the poor compliance and inconvenience for CBT is always a big issue.
Except the traditional treatment of insomnia, some folk therapies' clinical effect does not been confirmed, such as aromatherapy, music therapy, etc. Nowadays, due to development of technology for medical devices, some sleep devices were launched, aim to prolong the slow-wave sleep and enhances the sleeping quality.
The investigational device in this study is a sleep device with SRF (Sleep Restore Frequency), the principle is to integrate the bio-energy generated Schumann resonances, native from Earth, and the shocks from the Earth's magnetic field. Through the non-contact method with bio-energy waves, SRF are coupled to the sleep center of the brain, inducing and adjusting the electrical activities of the sleep center. It prolongs the in-depth sleep and enhances the sleeping quality.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) participants are between 20 and 70 years old;
- •(2) participants must meet the DSM-5 diagnostic criteria for insomnia and have been diagnosed for more than three months;
- •(3) participants must be willing to sign an informed consent form;
- •(4) participants who took sleep aiding pills must cooperate not to change any medication and dosage during the study.
排除标准
- •(1) participants using pacemakers or cardiac monitors;
- •(2) participants with severe physical illness or after surgery, such as heart disease, metabolic diseases, or cancer;
- •(3) participants with severe mental disorders, such as schizophrenia, severe major depression, severe anxiety, bipolar disorder, dementia, substance use disorder; or severe neurological diseases such as a seizure, stroke or Parkinson's disease;
- •(4) participants with other serious sleep disorders, such as severe sleep obstructive apnea, severe periodic limb movement syndrome or narcolepsy;
- •(5) participants who are unable to attend regular follow-up evaluations;
- •(6) participants who are unable to keep good sleep hygiene and cannot stop using electronic products before going to bed.
结局指标
主要结局
actigraphy
时间窗: 4 weeks
Change in sleep latency (mins) based on actigraphy from before treatment to after treatment.
次要结局
- actigraphy-WASO(4 weeks)
- actigraphy-TST(4 weeks)
- polysomnography (PSG)-SE(before and after 4 weeks using sleep device)
- polysomnography (PSG)-SL(before and after 4 weeks using sleep device)
- polysomnography (PSG)-WASO(before and after 4 weeks using sleep device)
- actigraphy-SE(4 weeks)
- polysomnography (PSG)-TST(before and after 4 weeks using sleep device)
- Pittsburgh Sleep Quality Index (PSQI)(before, after 2 weeks, and after 4 weeks using sleep device)
- polysomnography (PSG)-SWS(before and after 4 weeks using sleep device)
- polysomnography (PSG)-REM(before and after 4 weeks using sleep device)
- 36-Item Short-Form Health Survey (SF-36)(before, after 2 weeks, and after 4 weeks using sleep device)
- sleep diary (sleep logs)-TST(before, after 2 weeks, and after 4 weeks using sleep device)
- sleep diary (sleep logs)-SL(before, after 2 weeks, and after 4 weeks using sleep device)
- sleep diary questionaire (sleep logs)-SE(before, after 2 weeks, and after 4 weeks using sleep device)