KCT0007512招募中未知
The effects of non-invasive focused ultrasound intervention for sleep and pilot study for safety/efficacy evaluation in sleep disorders
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 45
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
- 20(Year) 至 65(Year)（—）
- 性别
- All
入选标准
- •a. Adult men and women aged between 20 and under 65
- •(Based on selection: Including young people, middle-aged, and adults in early old age, excluding children, adolescents, and the elderly who can participate in clinical trials according to their voluntarily and faithfully participation in research.)
- •b. Subjects who consented to participate in this study and signed a written informed consent
- •c. Those who have completed the Pittsburgh Sleep Quality Index (PSQI) test
- •?: According to previous studies, PSQI score of 5 or less on a 5-point scale was evaluated as sufficient sleep, and a score of 6 or higher was evaluated as poor quality of sleep.
排除标准
- •a. Subjects with a history of being diagnosed with a neuropsychiatric disorder, or with the diagnosis of following sleep disorders or symptoms
- •- Moderate to severe symptomatic snoring, and/or Sleep apnea with more than an apnea-hypopnea index of 15/hour
- •- History of Narcolepsy or Periodic limb movement during sleep
- •- Comorbid psychiatric diseases such as major depressive disorder
- •b. If you have experienced undue stressful changes within 2 weeks of your first visit:
- •Spouse death, family discord, lawsuit/dispute, sudden hardship, etc.
- •c. Those taking medications that could significantly affect sleep maintenance and onset within 1 month of the first visit
- •d. Among those taking drugs or food that may affect sleep, those who find it difficult to maintain or stop taking drugs or food according to the guidance of the medical staff from 2 weeks before the start of the test until the end of the test
- •e. People who consume excessive alcohol on a regular basis (>140g/week, about 2.5 bottles/week of soju, about 2.5 glasses/day)
- •f. People who smoke excessively (> 10 cigarettes/day)
- •g. People who consume excessive caffeine on a regular basis (> 10 cups of coffee per day)
- •h. Those with a BMI of 18 kg/m2 or less or 35 kg/m2 or more
- •i. Those who participated in the clinical trial within 1 month of the first visit
- •j. Pregnant women (positive hCG pregnancy test in urine) or women planning to become pregnant
- •k. Those who cannot receive brain CT and MRI examinations
- •l. Those who have a skull thickness of 8 mm or more or have clinically significant calcification in brain CT examination
- •m. Those with structural abnormalities such as changes due to brain tumor, brain hemorrhage, traumatic brain disease, or degenerative brain disease in brain MRI examination
- •n. People with severe physical illness (cancer, tuberculosis, etc.)
- •o. Those with sensitive skin diseases including contact skin diseases
- •p. If the researcher determines that it is inappropriate to participate in this study
- •- In case of non-cooperative participation in the experiment
- •- If you do not understand the explanation or have difficulty filling out the questionnaire
- •q. unacceptable concomitant medications
- •- Patients who have or are taking psychotropic drugs
- •- Treatment for chronic brain disease
- •- Patients with high fever
- •- Patients with bleeding due to various surgeries, etc.
- •- Patients with cerebral edema
- •- If you have a history of convulsive seizures
- •- Patients with complications that may be risky to practice
- •- Other patients deemed inappropriate by the attending physician
- •- When using together with other electronic medical devices, you must obtain permission from your doctor.
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