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

Phase 1

Recruiting

• Conditions: Insomnia, depression, subthreshold depression, mild cognitive impairment

• Registration Number: ITMCTR2100005237
• Lead Sponsor: Shenzhen Hospital of Beijing University of Traditional Chinese Medicine (Longgang)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Observational study
• Study Design: Not specified