Insomnia
Conditions
Interventions
Experimental group:Administration of Bifidobacterium animalis subsp. lactis Bbm-19 combined drug (access to standardised treatment), once daily, one bag at a time for 6 weeks
Control group:Administration of a placebo without Bifidobacterium animalis subsp. lactis Bbm-19 combined drug (access to standardised treatment), once daily, one bag at a time for 6 weeks
Sponsors
The Third Hospital of Inner Mongolia Autonomous Region (Mental Health Center)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for chronic insomnia disorder in the International Classification of Sleep Disorders, Third Edition (ICSD); 2. Aged ?18 years; 3. Have a regular work and rest schedule; 4. Have no serious physical illnesses, neurological, pain syndromes, or cancer, and have no allergies to medications; 5. Have and know how to use smart devices (e.g. smart phones, tablets, computers, etc.); 6. Understand and comply with the programme and sign the written informed consent.
Exclusion criteria
Exclusion criteria: 1. Suffering from a diagnosed cause or serious medical condition that directly affects sleep; 2. Suffering from severe anxiety, depression, neurological disorders or other sleep disorders; 3. Undergoes gastrointestinal surgery in the last year, suffers from inflammatory bowel disease; 4. The presence of alcohol, drug or neuro-narcotic dependence; 5. Pregnant or breastfeeding women, shift workers, permanent night workers, frequent flights across time zones; 6. A history of other serious systemic disease that, in the opinion of the investigator, makes the subject unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh sleep quality index;Insomnia severity index;Polysomnogram; | — |
Secondary
| Measure | Time frame |
|---|---|
| Morning and Evening Questionnaire;Beck Depression Inventory;Beck Anxiety Inventory; | — |
Countries
China
Contacts
Public ContactZhang Huiru
The Third Hospital of Inner Mongolia Autonomous Region (Mental Health Center)
Outcome results
None listed