Obstructive Sleep Apnea Symptom
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients able to provide written informed consent and to fulfil study request; 2. Outpatients, male or female, aged between 30 and 70 years (include), smoking or non-smoking; 3. Patients with a clinical diagnosis of moderate to severe OSASand not willing to accept operation, CPAP or oral appliance(OA) treatment; (1) Moderate: AHI 15-30Lowest SaO2 80-85%; (2) Severe: AHI > 30; (3) Lowest SaO2 < 80%.
Exclusion criteria
Exclusion criteria: 1. Patients with a diagnosis of COPD, bronchial asthma, cystic fibrosis, active pulmonary tuberculosis, pneumonia, bronchial pneumonia, bronchiectasis, lung cancer or lung metastases, other progressively fatal disease; 2. FEV1/FVC 1.5×ULN)or renal function (Cr> 1.0×ULN). hematopoietic disorder, bleeding tendency or hemorrhagic disease; 4. Patients requiring mechanical airway management, long-term oxygen therapy (12 h or more per day) or respiratory rehabilitation; 5. Hospitalized patients and patients from institutional care facilities; 6. Immuno-compromised patients, HIV positive or patients on long term treatment with corticosteroids or immunosuppressive agents; 7. Patients with suspected or known hypersensitivity to the study product or to any of its excipients (such as for sucrose: patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency); 8. Patients known to have conditions affecting study drug absorption or history of peptic ulcer; 9. Pregnant or lactating women, or in post-menopause for less than 1 year; 10. Patients presenting poor reliability and poor compliance (e.g. history of alcohol or drug abuse, bad mental conditions); 11. Patients who have received any other investigational drug within 3 months prior to study entry; 12. Unsuitable for the study for every other reason, in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AHI;Lowest SaO2;new-onset cardiovascular and cerebrovascular event; | — |
Secondary
| Measure | Time frame |
|---|---|
| SIT90;Epworth sleepiness scale;blood pressure;blood glucose;Blood Lipid;CRP;New Diagnosed hypertension,coronary heart disease,;percentage of slow wave sleep;arousal index; | — |
Countries
China
Contacts
Tianjin Medical University General Hospital