Obstructive Sleep ApneaNCT03163615
Effect of Tibet Rhodiola Capsule on Hypoxia and Cardiovascular Risk Factors in Patients With Obstructive Sleep Apnea
A study testing Tibet Rhodiola Capsule in people with Obstructive Sleep Apnea, run by Shao-Ping Nie at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tibet Rhodiola Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2017to 30 May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029
Shao-Ping Nie, MD, PhD, 86-10-84005256, spnie@126.com
Shao-Ping Nie, MD, PhD
About this study
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
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tibet Rhodiola Capsule, Placebo oral capsule
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tibet Rhodiola CapsuleDrug
Also called Xueyu Hongjingtian Huoli Jiaonang
4 capsules, po, from admission up to 84 days
Placebo oral capsuleDrug
4 capsules, po, from admission up to 84 days
| Study group | Role | What they receive |
|---|---|---|
| Tibet Rhodiola Capsule | Experimental | Not described Receives: Drug: Tibet Rhodiola Capsule |
| Placebo oral capsule | Placebo comparator | Not described Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average oxygen saturation
Average oxygen saturation was assessed by home sleep apnea testing(HSAT)
Measured: Change from Baseline to 84±4days
Secondary outcomes (10)
Lowest saturation
Lowest saturation in percentage(%) was assessed by home sleep apnea testing(HSAT)
Measured: 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)
Measured: baseline and 84±4days
AHI
AHI was assessed by home sleep apnea testing(HSAT)
Measured: baseline and 84±4days
Heart rate variability
Heart rate variability was assessed by Holter
Measured: baseline and 84±4days
Coronary flow reserve
Coronary flow reserve was assessed by Ultrasonic Cardiogram
Measured: baseline and 84±4days
Platelet(PLT) count
PLT in 10^9/L
Measured: baseline, 28±2days and 84±4days
Low density lipoprotein-cholesterol(LDL-C)
LDL-C in mmol/L
Measured: baseline, 28±2days and 84±4days
Glycosylated hemoglobin (HbAlc)
HbAlc in percentage(%)
Measured: baseline and 84±4days
Epworth sleepiness scale (ESS)
questionnaire
Measured: baseline and 84±4days
Quality of life scale (WHOQOL-BREF)
questionnaire
Measured: baseline and 84±4days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2017
- Study start17 Jun 2017
- Primary completion28 Feb 2018 (estimated)
- Study completion30 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shao-Ping Nie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shao-Ping Nie, Beijing Anzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03163615
- Sponsor's protocol ID
- 2017002
- Status last verified
- Jul 2017
- First submitted
- 15 May 2017
- Last updated
- 26 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03163615
- Acronym / sponsor ID
- 2017002
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shao-Ping NieUniversity, hospital or other
- Study start
- 17 Jun 2017 (actual)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 May 2018 (estimated)
- First posted
- 23 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tibet Rhodiola Capsule | Experimental | Drug: Tibet Rhodiola Capsule |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tibet Rhodiola CapsuleAlso: Xueyu Hongjingtian Huoli Jiaonang4 capsules, po, from admission up to 84 days | Drug | Tibet Rhodiola Capsule |
| Placebo oral capsule4 capsules, po, from admission up to 84 days | Drug | Placebo oral capsule |
Primary outcome
Average oxygen saturation
Time frame: Change from Baseline to 84±4days
Average oxygen saturation was assessed by home sleep apnea testing(HSAT)
10 secondary outcomes
Lowest saturation
Time frame: baseline and 84±4days
Percentage of total sleep time associated with saturation lower than 90% (T90SaO2 )
Time frame: baseline and 84±4days
AHI
Time frame: baseline and 84±4days
Heart rate variability
Time frame: baseline and 84±4days
Coronary flow reserve
Time frame: baseline and 84±4days
Platelet(PLT) count
Time frame: baseline, 28±2days and 84±4days
Low density lipoprotein-cholesterol(LDL-C)
Time frame: baseline, 28±2days and 84±4days
Glycosylated hemoglobin (HbAlc)
Time frame: baseline and 84±4days
Epworth sleepiness scale (ESS)
Time frame: baseline and 84±4days
Quality of life scale (WHOQOL-BREF)
Time frame: baseline and 84±4days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tibet Rhodiola Capsule in people with Obstructive Sleep Apnea, run by Shao-Ping Nie at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average oxygen saturation (time frame: Change from Baseline to 84±4days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.