Obstructive Sleep Apnea
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Aged 18–65 years, willing to participate in the study and provide written informed consent; OSA group:1.Apnea-Hypopnea Index / Respiratory Event Index (AHI/REI) >= 15 events/hour; 2.No history of neuropsychiatric disorders or other sleep disorders. Healthy Control Group: 1.No sleep disorders;2.No sleep-related complaints.
Exclusion criteria
Exclusion criteria: 1. Use of antibiotics, gut microbiota preparations, proton pump inhibitors, or immunosuppressive drugs within 2 months prior to enrollment; 2. Presence of other severe systemic diseases (e.g., heart failure, hepatic or renal dysfunction, cancer, rheumatic immune diseases, or conditions affecting the gut microbiota); 3. History of prior gastrointestinal surgery;pregnancy or lactation; 4.Taking sedatives, benzodiazepines, and other medications that affect sleep; 5. Receive OSA-related treatment, including but not limited to surgery and mechanical ventilation; 6. Presence of gastrointestinal disorders, such as ulcerative colitis and irritable bowel syndrome.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Epworth Sleepiness Scale (ESS) score;Insomnia Score Index;Gut microbiota diversity and composition;Pittsburgh Sleep Quality Index(PSQI);Mean oxygen saturation(SpO2 Mean);Nadir oxygen saturation(SpO2 Nadir);Ratio of Sleep Stage;Arousal Index;Fasting Plasma Glucose;Fasting Insulin;Total Cholesterol;Triglyceride;High-Density Lipoprotein Cholesterol;Low-Density Lipoprotein Cholesterol;High-sensitivity C-reactive protein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Apnea Hypoapnea Index;Respiratory Event Index;Hospital Anxiety and Depression Scale – Anxiety subscale;Metabolic parameters;Inflammatory markers;Anthropometric measures(body mass index (BMI), neck circumference, waist circumference, waist-to-hip ratio); | — |
Countries
China
Contacts
Department of Pulmonary and Critial Care Medicine,The First Medcila Center of Chinese PLA General Hospital