NCT03163615UnknownNot Applicable
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
Shao-Ping Nie1 site in 1 country80 target enrollmentStarted: June 17, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Average oxygen saturation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Tibet Rhodiola Capsule
Experimental
Intervention: Tibet Rhodiola Capsule (Drug)
Placebo oral capsule
Placebo Comparator
Intervention: Placebo oral capsule (Drug)
Outcomes
Primary Outcomes
Average oxygen saturation
Time Frame: Change from Baseline to 84±4days
Average oxygen saturation was assessed by home sleep apnea testing(HSAT)
Secondary Outcomes
- Lowest saturation(baseline and 84±4days)
- Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )(baseline and 84±4days)
- AHI(baseline and 84±4days)
- Heart rate variability(baseline and 84±4days)
- Low density lipoprotein-cholesterol(LDL-C)(baseline, 28±2days and 84±4days)
- Epworth sleepiness scale (ESS)(baseline and 84±4days)
- Quality of life scale (WHOQOL-BREF)(baseline and 84±4days)
- Coronary flow reserve(baseline and 84±4days)
- Platelet(PLT) count(baseline, 28±2days and 84±4days)
- Glycosylated hemoglobin (HbAlc)(baseline and 84±4days)
Investigators
Shao-Ping Nie
MD, PhD
Beijing Anzhen Hospital
Study Sites (1)
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