KCT0009489尚未招募Unknown
Research on Sleep data and Biomarkers for the Registry of Insomnia Patient: a Cross-sectional Study
Pusan National University Korean Medicine Hospital0 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19(Year) 至 80(Year)（—）
- 性别
- All
入选标准
- •1) Since this study is a research study on the characteristics of insomnia patients, the sample size is set to 100 by setting the margin of error (sample error) of 9.8% as the number of samples considering the budget when applying the sample number formula from the perspective of the research study.
- •2) On the other hand, if the number of samples for correlation analysis between the biomarkers of insomnia patients and various indicators related to sleep (such as sleep disturbance, quality of life, and core emotion scale) is applied, it is calculated as 84 when the significance level is 5%, the power is 80%, and the medium effect size (= correlation coefficient) is considered (= 0.3), and 93 when the dropout rate is considered.
- •3) Considering the above two methods, the number of samples is conservatively determined and set at 100.
排除标准
- •1) Those with unstable (uncontrollable) schizophrenia, bipolar disorder, delusional disorder, etc. in the last 6 months or with an anxiety or depression score of 11 or higher on the Hospital Anxiety and Depression Scale (HADS)
- •2) Anyone using the C-PAP tool within the last 3 months
- •3) Those diagnosed with severe chronic diseases, organic lesions of the brain (brain tumors, stroke, epilepsy) or long-term diseases (malignant tumors, tuberculosis, chronic liver disease, chronic kidney disease, chronic heart disease, other rare metabolic diseases, hereditary diseases, hormonal disorders, etc.)
- •4) Any person who has participated in any other clinical trial with intervention within four weeks of the date of consent
- •5) A person who has a clear pain enough to disturb sleep or a disease that can cause sleeplessness
- •6) a woman who is pregnant, likely pregnant, or menstruating
- •7) If other clinical research personnel determine that it is not appropriate
研究者
相似试验
已完成
不适用
Sleep related breathing disorders in copd and osa-overlap syndrome patientsCTRI/2018/06/014442Dept of pulmonary critical care and sleep medicine Vmmc and Safdarjung hospital37
已完成
不适用
Assessment of sleep status and related factors in the intensive care unitCritically ill patientsJPRN-UMIN000047376Fukuyama City Hospital40
进行中（未招募）
不适用
Study of sleep characteristics and parameters in patients suffering from minors sleep disorders treated by the homeopathic medicinal product Somnidoron®, oral drops, solution. - SomnilogMinors sleep disordersMedDRA version: 8.1Level: LLTClassification code 10040984Term: Sleep disorderEUCTR2006-005103-33-FRaboratoires WELEDA
招募中
1 期
Study on the characteristic spectrum of sleep related factors in patients with insomnia diagnosed by single chief complaint of Wushen typeinsomniaITMCTR2100004655Ttraditional Chinese Medicine Hospital of Xinjiang Uygur Autonomous Region
已完成
不适用
Sleep Measuring with Non-Invasive Applications: the HealthBed Databasesleep disorders10040998NL-OMON46794Epilepsiecentrum Kempenhaeghe100