Clinical trial NCT03163615: Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Average oxygen saturation
timeFrame: Change from Baseline to 84±4days
Secondary outcomes:
measure: Lowest saturation
timeFrame: baseline and 84±4days
measure: Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )
timeFrame: baseline and 84±4days
measure: AHI
timeFrame: baseline and 84±4days
measure: Heart rate variability
timeFrame: baseline and 84±4days
measure: Coronary flow reserve
timeFrame: baseline and 84±4days
measure: Platelet(PLT) count
timeFrame: baseline, 28±2days and 84±4days
measure: Low density lipoprotein-cholesterol(LDL-C)
timeFrame: baseline, 28±2days and 84±4days
measure: Glycosylated hemoglobin (HbAlc)
timeFrame: baseline and 84±4days
measure: Epworth sleepiness scale (ESS)
timeFrame: baseline and 84±4days
measure: Quality of life scale (WHOQOL-BREF)
timeFrame: baseline and 84±4days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital, Capital Medical University
Study officials:
References: