ITMCTR2100005237RecruitingPhase 1
To study the infrared thermal imaging characteristics of insomnia, mild cognitive impairment, depression and subthreshold depression based on the holistic view of Traditional Chinese Medicine
Shenzhen Hospital of Beijing University of Traditional Chinese Medicine (Longgang)0 sitesStarted: TBDLast updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational study
Eligibility Criteria
- Ages
- 18 to 80 (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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