Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea: A Pilot Trial

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: Tibet Rhodiola Capsule
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >18 years, males or females; HSAT or PSG testing within recent 3 months; AHI 5-30 and lowest oxygen saturation<85%; Refuse to accept CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA; Written informed consent. Exclusion Criteria: History of CPAP, Mandibular orthosis device, surgery, or other medications to improve OSA; Significant central sleep apnea; Histories of other sleep disorders: insomnia, chronic sleep deprivation, long-term use of sleeping pills or sedatives, restless legs syndrome; 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; History of myocardial infarction, coronary revascularization, and a known degree of stenosis > 75% of the coronary lesions; 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; Patients with malignant tumors, lymphoma and neuropsychiatric disorders; Patients with major surgery or trauma within 3 months, and active bleeding or cerebrovascular accident within 6 months; History of anemia (hemoglobin<90g/L) or thrombocytopenia (thrombocyte <90×10^9/L); Breastfeeding, pregnant, or potentially fertile women; Patients who have known to be allergic to Tibet Rhodiola Capsule or its components or patients with serious adverse effect; Participation in other clinical trials in recent 3 months; Patients who cannot complete this trial or comply with the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibet Rhodiola Capsule<br> | Drug: Tibet Rhodiola Capsule<br>* 4 capsules, po, from admission up to 84 days<br>* Other names: Xueyu Hongjingtian Huoli Jiaonang;|
| Placebo Comparator: Placebo oral capsule<br> | Drug: Placebo oral capsule<br>* 4 capsules, po, from admission up to 84 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average oxygen saturation | Average oxygen saturation was assessed by home sleep apnea testing(HSAT) | Change from Baseline to 84±4days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest saturation | Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT) | baseline and 84±4days | 
| Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 ) | T90SaO2 in percentage(%) was assessed by home sleep apnea testing(HSAT) | baseline and 84±4days | 
| AHI | AHI was assessed by home sleep apnea testing(HSAT) | baseline and 84±4days | 
| Heart rate variability | Heart rate variability was assessed by Holter | baseline and 84±4days | 
| Coronary flow reserve | Coronary flow reserve was assessed by Ultrasonic Cardiogram | baseline and 84±4days | 
| Platelet(PLT) count | PLT in 10^9/L | baseline, 28±2days and 84±4days | 
| Low density lipoprotein-cholesterol(LDL-C) | LDL-C in mmol/L | baseline, 28±2days and 84±4days | 
| Glycosylated hemoglobin (HbAlc) | HbAlc in percentage(%) | baseline and 84±4days | 
| Epworth sleepiness scale (ESS) | questionnaire | baseline and 84±4days | 
| Quality of life scale (WHOQOL-BREF) | questionnaire | baseline and 84±4days |