研究疾病:
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失眠 、抑郁、阈下抑郁、轻度认知障碍
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研究疾病代码:
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Target disease:
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Insomnia, depression, subthreshold depression, mild cognitive impairment
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Target disease code:
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研究类型:
Study type:
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观察性研究
Observational study
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研究设计:
Study design:
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横断面
Cross-sectional
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研究所处阶段:
Study phase:
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I期临床试验
Phase I clinical trial
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研究目的:
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本研究结合红外热成像技术,从中医整体观角度出发,初步探讨失眠、轻度认知障碍、抑郁及阈下抑郁不同证型的红外热成像临床特征分布,为建立失眠、轻度认知障碍、抑郁及阈下抑郁等疾病主客观结合的中医证型(脏腑辨证)诊断模式奠定基础。
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Objectives of Study:
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Combined with infrared thermal imaging technology, from the perspective of the holistic view of traditional Chinese medicine, this study preliminarily explored the distribution of clinical characteristics of infrared thermal imaging in different syndromes of insomnia, mild cognitive impairment, depression and subthreshold depression, to lay the foundation for the establishment of a TCM syndrome type (Zang-Fu-organ syndrome differentiation) diagnosis model for diseases such as insomnia, mild cognitive impairment, depression and subthreshold depression.
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药物成份或治疗方案详述:
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Description for medicine or protocol of treatment in detail:
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纳入标准:
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1、失眠纳入标准:
(1)符合西医失眠的诊断标准;
(2)年龄在18至80岁之间;
(3)意识、思维清晰、可用语言交流;
(4)匹兹堡睡眠质量指数>5;
(5)受试者自愿参加临床试验,并签署知情同意书者,程序符合GCP要求。
2、抑郁症纳入病例标准:
(1)符合抑郁症的诊断标准;
(2)性别不限,年龄≥18岁;
(3)能独立完成问卷,知情同意并自愿参与。
3、阈下抑郁纳入病例标准:
(1)符合阈下抑郁的诊断标准,流调中心用抑郁量表(CES-D)评分≥16分,汉密尔顿抑郁量表(HAMD-17)评分:7分≤HAMD总分<17分;
(2)性别不限,年龄≥18岁;
(3)能独立完成问卷,知情同意并自愿参与。
4、轻度认知障碍纳入病例标准:
(1)符合MCI诊断标准;
(2)MoCA得分<26,若受教育年限≤12年,则在得分基础上加1分;
(3)年龄在50至80岁之间;
(4)签署知情同意书。
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Inclusion criteria
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1. Insomnia inclusion criteria:
(1) Meet the diagnostic criteria of western medicine for insomnia;
(2) Aged 18-80 years;
(3) Consciousness, clear thinking, and use of language to communicate;
(4) Pittsburgh Sleep Quality Index > 5;
(5) The subjects voluntarily participate in the clinical trial and sign the informed consent form, and the procedure meets the requirements of GCP.
2. Depression included in the case criteria:
(1) Meet the diagnostic criteria for depression;
(2) Gender is not limited, aged >= 18 year;
(3) Able to independently complete the questionnaire, give informed consent and participate voluntarily.
3. Subthreshold depression included in the case criteria:
(1) Meet the diagnostic criteria for subthreshold depression, the Central Epidemiological Survey Depression Scale (CES-D) score >= 16 points, and the Hamilton Depression Scale (HAMD-17) score: 7 points <= HAMD total score < 17 points;
(2) Gender is not limited, aged >= 18 years;
(3) Able to independently complete the questionnaire, give informed consent and participate voluntarily.
4. Mild cognitive impairment included in the case criteria:
(1) Meet the MCI diagnostic criteria;
(2) MoCA score < 26, if the years of education <= 12 years, add 1 point to the score;
(3) Aged between 50 and 80 years;
(4) Sign the informed consent.
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排除标准:
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1、失眠病例排除标准:
(1)凡是全身性疾病如疼痛、发热、咳嗽、手术等,以及外界环境干扰因素引起失眠者;
(2)对睡眠造成影响的严重精神病,如:精神分裂症,双相情感障碍,偏执性精神障碍,分裂情感性精神障碍,癫痫所致精神障碍,严重精神发育迟滞;
(3)妊娠、哺乳者和有妊娠计划者;
(4)对芳香类药物过敏或严重不良反应病史者,及严重过敏体质者;
(5)合并有其他严重循环系统、造血系统、消化系统、内分泌系统等疾病者;
(6)正在参加其他药物临床试验者。
2、阈下抑郁及抑郁排除病例标准:
(1)既往精神病性障碍或器质性精神障碍患者;
(2)精神活性物质和非成瘾性物质所致的抑郁发作;
(3)妊娠、哺乳者和有妊娠计划者;
(4)已知的酗酒嗜酒、吸毒或其他药物滥用史者;
(5)患者有强烈自杀企图或行为;
(6)拒绝完成任何一项观察性指标采集的患者。
3、轻度认知障碍排除标准:
(1)痴呆患者或服用抗痴呆药物者;
(2)急性脑血管疾病、脑萎缩、甲状腺、贫血、炎症等引起的认知障碍;
(3)曾有严重酒精、药物滥用史;
(4)抑郁引起的认知障碍者;
(5)因中毒或药物等其他原因导致的认知功能障碍者。
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Exclusion criteria:
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1. Exclusion criteria for insomnia cases:
(1) All systemic diseases such as pain, fever, cough, surgery, etc., as well as insomnia caused by external environmental interference factors;
(2) Severe mental illness that affects sleep, such as: schizophrenia, bipolar disorder, paranoid disorder, schizoaffective disorder, mental disorder caused by epilepsy, and severe mental retardation;
(3) Those who are pregnant, breastfeeding and those who plan to become pregnant;
(4) Those who are allergic to aromatic drugs or have a history of severe adverse reactions, and those with severe allergic constitution;
(5) Those with other serious diseases of the circulatory system, hematopoietic system, digestive system, endocrine system, etc.;
(6) Those who are participating in clinical trials of other drugs.
2. Subthreshold depression and exclusion criteria for depression:
(1) Patients with previous psychotic disorder or organic mental disorder;
(2) Depressive episodes caused by psychoactive substances and non-addictive substances;
(3) Those who are pregnant, breastfeeding and those who plan to become pregnant;
(4) Known history of alcoholism, drug addiction or other drug abuse;
(5) The patient has a strong suicide attempt or behavior;
(6) Patients who refuse to complete the collection of any observational index.
3. Exclusion criteria for mild cognitive impairment:
(1) Dementia patients or those taking anti-dementia drugs;
(2) Cognitive impairment caused by acute cerebrovascular disease, brain atrophy, thyroid, anemia, inflammation, etc.;
(3) Have a history of severe alcohol or drug abuse;
(4) Cognitive impairment caused by depression;
(5) Cognitive dysfunction due to other reasons such as poisoning or drugs.
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研究实施时间:
Study execute time:
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从From
2021-08-26
至To
2022-08-01
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征募观察对象时间:
Recruiting time:
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从From
2021-09-01
至To
2022-08-01
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