Study on the role and potential mechanism of probiotics in alleviating insomnia

Not Applicable

• Conditions: Insomnia

• Registration Number: ChiCTR2400089002
• Lead Sponsor: The Third Hospital of Inner Mongolia Autonomous Region (Mental Health Center)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

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

Inclusion Criteria

1. Meet the diagnostic criteria for chronic insomnia disorder in the International Classification of Sleep Disorders, Third Edition (ICSD); <br>2. Aged ?18 years;<br>3. Have a regular work and rest schedule;<br>4. Have no serious physical illnesses, neurological, pain syndromes, or cancer, and have no allergies to medications;<br>5. Have and know how to use smart devices (e.g. smart phones, tablets, computers, etc.);<br>6. Understand and comply with the programme and sign the written informed consent.

Exclusion Criteria

1. Suffering from a diagnosed cause or serious medical condition that directly affects sleep;<br>2. Suffering from severe anxiety, depression, neurological disorders or other sleep disorders;<br>3. Undergoes gastrointestinal surgery in the last year, suffers from inflammatory bowel disease;<br>4. The presence of alcohol, drug or neuro-narcotic dependence;<br>5. Pregnant or breastfeeding women, shift workers, permanent night workers, frequent flights across time zones;<br>6. A history of other serious systemic disease that, in the opinion of the investigator, makes the subject unsuitable for participation in this study

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Pittsburgh sleep quality index;Insomnia severity index;Polysomnogram;

Secondary Outcome Measures

Name	Time	Method
Morning and Evening Questionnaire;Beck Depression Inventory;Beck Anxiety Inventory;