Insomnia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Insomnia group: 1. All patients meet the diagnostic criteria of ICSD-3 chronic insomnia, and other sleep disorders are excluded by diagnostic interview for sleep patterns and sleep disorders (DISP); 2. According to the mini-international neuropsychiatric interview (M.I.N.I.) Chinese version 5.0.0 structured meeting, major depressive disorder, anxiety disorder and other mental disorders are excluded; 3. The symptoms of insomnia lasted for more than 3 months; 4. Aged 18-60 years; 5. Insomnia severity index (ISI) score >= 14; 6. The body mass index (BMI) 18.5-23.9 kg/m2. Healthy controls: 1. According to DISP, sleep disorders are excluded; 2. According to the M.I.N.I. structured meeting, mental disorders are excluded; 3. Aged 18-60 years; 4. Insomnia severity index (ISI) score < 14; 5. The body mass index (BMI) 18.5-23.9 kg/m2.
Exclusion criteria
Exclusion criteria: 1. Complicated with severe somatic or brain organic diseases; 2. Complicated with other mental disorders, personality disorder or psychoactive substance abuse or dependence; 3. Complicated with other sleep disorders, including excessive daytime drowsiness, sleep-related respiratory diseases, sleep-related motor disorders or sleep circadian rhythm disorders; 4. Regular consumption of probiotic drugs or drinks in the past 1 month; 5. Antibiotics have been used in the past 3 months; 6. Severe diarrhea in the past 3 months (3 or more water samples per day for 3 days or more); 7. Severe constipation in the past 3 months (defecation twice or less per week, with defecation difficulty); 8. History of regular drinking; 9. Menstrual, pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| gut microbiota;oral microbiota;metabonomics;transcriptome;polysomnography; | — |
Secondary
| Measure | Time frame |
|---|---|
| inflammatory factors;clinical neuropsychological scales; | — |
Countries
China
Contacts
The first affiliated Hospital of Jinan University