Obstructive Sleep Apnea
Conditions
Brief summary
The purpose of this study is to evaluate the effect of Tibet Rhodiola Capsule on hypoxia and the cardiovascular risk factors in patients with mild to moderate OSA.
Interventions
DRUGTibet Rhodiola Capsule
4 capsules, po, from admission up to 84 days
DRUGPlacebo oral capsule
4 capsules, po, from admission up to 84 days
Sponsors
Shao-Ping Nie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age \>18 years, males or females; 2. HSAT or PSG testing within recent 3 months; 3. AHI 5-30 and lowest oxygen saturation\<85%; 4. Refuse to accept CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA; 5. Written informed consent.
Exclusion criteria
1. History of CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA; 2. Significant central sleep apnea; 3. Histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use of sleeping pills or sedatives, restless legs syndrome; 4. Histories of underlying heart disease (cardiomyopathy, myocarditis, pericarditis or severe valvular disease), cardiogenic shock and heart failure (NYHA or Killip class 3-4), persistent atrial or ventricular arrhythmias; 5. History of myocardial infarction, coronary revascularization, and a known degree of stenosis \> 75% of the coronary lesions; 6. Histories of known serious liver dysfunction (ALT or AST levels above 3 times the normal limit), renal insufficiency (GFR\<30ml/min), moderate and severe chronic obstructive pulmonary disease, and pulmonary arterial hypertension; 7. Patients with malignant tumors, lymphoma and neuropsychiatric disorders; 8. Patients with major surgery or trauma within 3 months, and active bleeding or cerebrovascular accident within 6 months; 9. History of anemia (hemoglobin\<90g/L) or thrombocytopenia (thrombocyte \<90×10\^9/L); 10. Breastfeeding, pregnant, or potentially fertile women; 11. Patients who have known to be allergic to Tibet Rhodiola Capsule or its components or patients with serious adverse effect; 12. Participation in other clinical trials in recent 3 months; 13. Patients who cannot complete this trial or comply with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average oxygen saturation | Change from Baseline to 84±4days | Average oxygen saturation was assessed by home sleep apnea testing(HSAT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 ) | baseline and 84±4days | T90SaO2 in percentage(%) was assessed by home sleep apnea testing(HSAT) |
| AHI | baseline and 84±4days | AHI was assessed by home sleep apnea testing(HSAT) |
| Heart rate variability | baseline and 84±4days | Heart rate variability was assessed by Holter |
| Coronary flow reserve | baseline and 84±4days | Coronary flow reserve was assessed by Ultrasonic Cardiogram |
| Lowest saturation | baseline and 84±4days | Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT) |
| Low density lipoprotein-cholesterol(LDL-C) | baseline, 28±2days and 84±4days | LDL-C in mmol/L |
| Glycosylated hemoglobin (HbAlc) | baseline and 84±4days | HbAlc in percentage(%) |
| Epworth sleepiness scale (ESS) | baseline and 84±4days | questionnaire |
| Quality of life scale (WHOQOL-BREF) | baseline and 84±4days | questionnaire |
| Platelet(PLT) count | baseline, 28±2days and 84±4days | PLT in 10\^9/L |
Countries
China
Outcome results
None listed