JPRN-jRCT1062220115招募中3 期
Randomised clinical trial to investigate the Efficacy of CPAP for Mild cognitive Impairment with Obstructive Sleep Apnoea - MORE
Fujii Masanori0 个研究点目标入组 130 人开始时间: 2023年3月31日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 50age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Aged 50 years and over
- •2) AHI over 20 on polysomnography or AHI over 40 on brief monitoring with a confirmed diagnosis of OSAS
- •3) Patients with a clinical diagnosis of MCI based on DSM-5 (Diagnostic & Statistical Manual of Mental Disorders,5th edition) or NIA-AA (National Institute on Aging-Alzheimer Association Joint Working Group) diagnostic criteria.
- •4) Cases in which the attending physician is able to judge that CPAP treatment is possible, and cases in which the patient lives with or has a family member who can support the patient as a study partner throughout the course of treatment (at least 3 times a week face to face or telephone contact is possible).
- •5) After receiving a full explanation of the study, select patients who have been fully informed about their participation in the study, and who have given their written consent, either by themselves or by a proxy, with full understanding.
排除标准
- •1) A respiratory event index of 60 or more on an out of center sleep testing or an apnoea-hypopnoea index of 60 or more on a Polysomnography
- •2) Psychiatric disorders such as depression and schizophrenia
- •3) Delirium
- •4) Parkinson's disease
- •5) Medical conditions affecting cognitive function (hypothyroidism, parathyroid disorders, vitamin B12 and folic acid deficiency, neurosyphilis, neuro-Beichet's disease and other collagen diseases, severe diabetes, chronic liver disorders, chronic respiratory diseases, hypoglycaemia, etc.)
- •6) Epilepsy
- •7) Neurosurgical diseases (e.g. brain tumours, chronic subdural haematomas, normal hydrocephalus) and massive stroke cases
- •8) Cases of new prescriptions or volume changes of dementia drugs in the last 3 months
- •9) Cases with a history of excessive alcohol consumption or alcohol dependence
- •10) Patients with severe visual or hearing impairment that interferes with daily life.
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