Insomnia
Conditions
Sponsors
Pidu District Hospital of Traditional Chinese Medicine, Chengdu City
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: Perimenopausal Insomnia Subjects: (1) Female, aged 40 to 60 years, right-handed; (2) Meet the diagnostic criteria of the 10th Edition of the Reproductive Aging Staging and the 3rd Edition of the International Classification of Sleep Disorders; (3) Pittsburgh Sleep Quality Index (PSQI) score > 7; (4) Had not taken any medication for at least 2 weeks before entering the study; (5) Voluntarily participated in this study and signed the informed consent form. Note: Only patients meeting all 5 of the above criteria can be included in this study. Healthy Subjects: (1) Female, aged 40 to 60 years, right-handed; (2) Meet the diagnostic criteria of the 10th Edition of STRAW+10; (3) Pittsburgh Sleep Quality Index (PSQI) score = 7; (4) Had not taken any medication for at least 2 weeks before entering the study; (5) Voluntarily participated in this study and signed the informed consent form. Note: Only patients meeting all 5 of the above criteria can be included in this study.
Exclusion criteria
Exclusion criteria: (1) Patients with bilateral ovarian removal, organic ovarian diseases, premature ovarian failure, polycystic ovary syndrome, hypothalamic amenorrhea; (2) Patients with systemic diseases such as hypertension, diabetes, coronary heart disease, obesity (BMI = 28); (3) Patients with severe life-threatening primary diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system diseases; (4) Patients with unconsciousness and inability to express subjective discomfort symptoms; (5) Patients with a history of mental disorders or organic neurological lesions in themselves or their first-degree relatives; (6) Patients with insomnia caused by alcohol abuse and/or abuse of psychotropic drugs (including sleeping pills); (7) Patients with severe depression and anxiety symptoms; (8) Patients with severe headache, migraine, history of head trauma and surgical history; (9) Patients who received estrogen, serotonin reuptake inhibitors or other alternative therapies within 4 weeks before enrollment; (10) Patients with a history of anticoagulants or regular use of sedatives or anti-anxiety drugs; (11) Patients who are pregnant, planning to become pregnant or breastfeeding; (12) Patients with claustrophobia, implanted metallic objects in the body, metal braces, etc., who have contraindications for magnetic resonance scanning. Note: All subjects who meet any of the above criteria will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index;Insomnia severity index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self Rating Depression Scale;Self Rating Anxiety Scale;Montreal Cognitive Assessment;Changes in brain structure;Chang in brain function;Serum inflammatory markers;Changes in the gut microbiota; | — |
Countries
China
Contacts
Public ContactXiaoQin Chen
Pidu District Hospital of Traditional Chinese Medicine, Chengdu City, Sichuan Province
Outcome results
None listed