Insomnia diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (A) Healthy adults aged =18 years; In the past 3 months, the sleep onset time was > 30 minutes, the total sleep time was < 6 hours, the sleep maintenance disorder, the number of awakenings throughout the night was =2, the early awakening, the decreased sleep quality, and daytime dysfunction. The diagnostic criteria of insomnia were: (a) significant dissatisfaction with the quality or quantity of sleep, accompanied by at least one of the following symptoms: difficulty falling asleep, difficulty maintaining sleep, characterized by frequent awakenings or difficulty falling asleep after awakenings, and unable to fall asleep again after waking up early; (b) sleep disturbances (or related daytime fatigue) that cause significant distress or impairment in social, occupational, educational, academic, behavioral, or other important social functioning; (c) dyssomnia occurred more than 3 times per week; (d) sleep difficulty =3 months; (e) sleep difficulties despite adequate sleep opportunities; (B) Voluntarily participated in the study; (C) Being conscious; (D) Able to communicate in language normally.
Exclusion criteria
Exclusion criteria: (A) Suffering from severe cardiovascular and cerebrovascular diseases, respiratory system diseases, immune system diseases, and severe liver and kidney damage; (B) Suffering from severe mental illness, such as depression, generalized anxiety disorder, etc.; (C) Patients with intestinal infection or other infectious diseases; (D) Patients with allergic reactions to gut microbiota transplantation; (E) Patients with intestinal tumors or other intestinal diseases; (F) Patients who fail to provide complete medical history or examination data; (G) For various reasons, the study could not be carried out. (H) Those with fever, pregnancy, lactation, severe systemic infection, etc.; (I) Use of antibiotics in the past 2 weeks; (J) Use of probiotics or immunomodulators in the past month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep assessment scales;Sex hormone;Hepatic and renal function;Immunologic function;Lymphocyte subpopulation;Amplification quantitative culture;Mass spectrum identification;16S rRNA Sequence;Metagenome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood fat;Glycated hemoglobin;Infectious disease indicators; | — |
Countries
China
Contacts
Wuxi Second People's Hospital