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

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

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 Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Drug: Tibet Rhodiola Capsule; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100029
    • Recruiting
    • Beijing Anzhen Hospital, Capital Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tibet Rhodiola Capsule	Drug: Tibet Rhodiola Capsule; 4 capsules, po, from admission up to 84 days; Other Names: Xueyu Hongjingtian Huoli Jiaonang
PLACEBO_COMPARATOR: Placebo oral capsule	Drug: Placebo oral capsule; 4 capsules, po, from admission up to 84 days

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shao-Ping Nie

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 17, 2017
• Primary Completion (ANTICIPATED): February 28, 2018
• Study Completion (ANTICIPATED): May 30, 2018

Study Registration Dates

• First Submitted: May 15, 2017
• First Submitted That Met QC Criteria: May 21, 2017
• First Posted (ACTUAL): May 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 26, 2017
• Last Update Submitted That Met QC Criteria: July 25, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Hypoxia
• Other Study ID Numbers: 2017002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No