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

Primary Purpose

Obstructive Sleep Apnea

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Tibet Rhodiola Capsule

Placebo oral capsule

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Beijing Anzhen Hospital, Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tibet Rhodiola Capsule

Placebo oral capsule

Arm Description

Outcomes

Primary Outcome Measures

Average oxygen saturation

Average oxygen saturation was assessed by home sleep apnea testing(HSAT)

Secondary Outcome Measures

Lowest saturation

Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT)

Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )

T90SaO2 in percentage(%) was assessed by home sleep apnea testing(HSAT)

AHI

AHI was assessed by home sleep apnea testing(HSAT)

Heart rate variability

Heart rate variability was assessed by Holter

Coronary flow reserve

Coronary flow reserve was assessed by Ultrasonic Cardiogram

Platelet(PLT) count

PLT in 10^9/L

Low density lipoprotein-cholesterol(LDL-C)

LDL-C in mmol/L

Glycosylated hemoglobin (HbAlc)

HbAlc in percentage(%)

Epworth sleepiness scale (ESS)

questionnaire

Quality of life scale (WHOQOL-BREF)

questionnaire

Full Information

NCT ID

NCT03163615

First Posted

May 15, 2017

Last Updated

July 25, 2017

Sponsor

Shao-Ping Nie

1. Study Identification

Unique Protocol Identification Number

NCT03163615

Brief Title

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

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

June 17, 2017 (Actual)

Primary Completion Date

February 28, 2018 (Anticipated)

Study Completion Date

May 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Shao-Ping Nie

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tibet Rhodiola Capsule

Arm Type

Experimental

Arm Title

Placebo oral capsule

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Tibet Rhodiola Capsule

Other Intervention Name(s)

Xueyu Hongjingtian Huoli Jiaonang

Intervention Description

4 capsules, po, from admission up to 84 days

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Intervention Description

4 capsules, po, from admission up to 84 days

Primary Outcome Measure Information:

Title

Average oxygen saturation

Description

Average oxygen saturation was assessed by home sleep apnea testing(HSAT)

Time Frame

Change from Baseline to 84±4days

Secondary Outcome Measure Information:

Title

Lowest saturation

Description

Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT)

Time Frame

baseline and 84±4days

Title

Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )

Description

T90SaO2 in percentage(%) was assessed by home sleep apnea testing(HSAT)

Time Frame

baseline and 84±4days

Title

AHI

Description

AHI was assessed by home sleep apnea testing(HSAT)

Time Frame

baseline and 84±4days

Title

Heart rate variability

Description

Heart rate variability was assessed by Holter

Time Frame

baseline and 84±4days

Title

Coronary flow reserve

Description

Coronary flow reserve was assessed by Ultrasonic Cardiogram

Time Frame

baseline and 84±4days

Title

Platelet(PLT) count

Description

PLT in 10^9/L

Time Frame

baseline, 28±2days and 84±4days

Title

Low density lipoprotein-cholesterol(LDL-C)

Description

LDL-C in mmol/L

Time Frame

baseline, 28±2days and 84±4days

Title

Glycosylated hemoglobin (HbAlc)

Description

HbAlc in percentage(%)

Time Frame

baseline and 84±4days

Title

Epworth sleepiness scale (ESS)

Description

questionnaire

Time Frame

baseline and 84±4days

Title

Quality of life scale (WHOQOL-BREF)

Description

questionnaire

Time Frame

baseline and 84±4days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Beijing Anzhen Hospital, Capital Medical University

City

Beijing

ZIP/Postal Code

100029

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shao-Ping Nie, MD, PhD

Phone

86-10-84005256

spnie@126.com

First Name & Middle Initial & Last Name & Degree

Shao-Ping Nie, MD, PhD

12. IPD Sharing Statement

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

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