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

Obstructive Sleep Apnea Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03163615
• Other study ID #: 2017002
• Status: Recruiting
• Phase: N/A
• First received: May 15, 2017
• Last updated: July 25, 2017
• Start date: June 17, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: July 2017
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: May 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• Tibet Rhodiola Capsule
4 capsules, po, from admission up to 84 days
• Placebo oral capsule
4 capsules, po, from admission up to 84 days

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shao-Ping Nie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average oxygen saturation	Average oxygen saturation was assessed by home sleep apnea testing(HSAT)	Change from Baseline to 84±4days
Secondary	Lowest saturation	Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT)	baseline and 84±4days
Secondary	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
Secondary	AHI	AHI was assessed by home sleep apnea testing(HSAT)	baseline and 84±4days
Secondary	Heart rate variability	Heart rate variability was assessed by Holter	baseline and 84±4days
Secondary	Coronary flow reserve	Coronary flow reserve was assessed by Ultrasonic Cardiogram	baseline and 84±4days
Secondary	Platelet(PLT) count	PLT in 10^9/L	baseline, 28±2days and 84±4days
Secondary	Low density lipoprotein-cholesterol(LDL-C)	LDL-C in mmol/L	baseline, 28±2days and 84±4days
Secondary	Glycosylated hemoglobin (HbAlc)	HbAlc in percentage(%)	baseline and 84±4days
Secondary	Epworth sleepiness scale (ESS)	questionnaire	baseline and 84±4days
Secondary	Quality of life scale (WHOQOL-BREF)	questionnaire	baseline and 84±4days