Obstructive Sleep ApnoeaNCT02015598
Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome
A study testing Carbocysteine and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnoea, run by Guangzhou Institute of Respiratory Disease at 1 site in China.
Trial summary
Obstructive sleep apnoea syndrome (OSAS) is characterised by repeated episodes of upper airway occlusion during sleep.It can cause cycles of hypoxia reoxygenation. And it was postulated that intermittent hypoxia seems to resemble ischemia-reperfusion.Many study suggest that ischemia-reperfusion represents an oxidative… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Obstructive Sleep Apnoea
- What is being tested?
- Carbocysteine and Continuous Positive Airway Pressure
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 2013to May 2014
- 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 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male in an age range of 18 to 65 years
- Obstructive Sleep Apnoea with an Apnea Hypopnea Index (AHI) of greater than or equal to 15 confirmed by polysomnography
- The patient is able to provide consent
- The patient were not receiving therapy for sleep apnoea,such CPAP or surgery.
Who cannot join
- Inability to tolerate Carbocysteine or CPAP
- Treatment with CPAP or surgery prior to or at the time of enrolment
- presence of active acute or chronic infection
- Patients with unstable cardiovascular diseases (unstable angina, myocardial infarction, stroke, or transient ischemic attacks), neuromuscular diseases, chronic respiratory diseases, peripheral vascular disease
- Using of steroidal , nonsteroidal anti-inflammatory, vasodilators ,lipid-lowering drugs,or other medications that lower oxidative stress.
- Intake of central relevant drugs, sedatives, or other drugs which impair sleep
Show all 9Show fewer
- Unwilling to participate in the study
- Participation in another clinical study in the past 4 weeks
- Shift worker
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou institute of respiratory disease
Guangzhou, Guangdong, 510120
About this study
Official title: Comparison of Oral Intake of Antioxidant Carbocysteine and Nasal Continuous Positive Airway Pressure (CPAP) for Treating in Moderate and Severe Obstructive Sleep Apnoea Syndrome Patients : a Randomized Clinical Trial
Obstructive sleep apnoea syndrome (OSAS) is characterised by repeated episodes of upper airway occlusion during sleep.It can cause cycles of hypoxia reoxygenation. And it was postulated that intermittent hypoxia seems to resemble ischemia-reperfusion.Many study suggest that ischemia-reperfusion represents an oxidative stress causing increased generation of reactive oxygen species, especially superoxide anions.It is one of the most important mechanisms of cardiovascular diseases, including hypertension, coronary artery disease and cerebrovascular accident complication with OSAS.So many individuals approve OSAS is an Oxidative Stress disease.
Continuous positive airway pressure (CPAP) is the first-line of treatment method in moderate/severe OSA.But poor adherence to CPAP treatment is very common.The failure rate with CPAP treatment is more than 50%.So we are searching a new treatment for that patients. Carbocysteine is a antioxidant.It can not only scavenges the free radicals but also replenishes glutathione(GSH)which is has double antioxidant capacity. However, Carbocysteine is cheaper than other which has double antioxidant capacity drugs,such as N-acetylcysteine.The purpose is to evaluate efficacy of oral intake of Antioxidant Carbocysteine witch can reduce oxidative stress and improve the symptom of OSAS.It recover the imbalance in the oxidant-anti-oxidant status may reduce cardiovascular abnormalities in Patients with OSAS.
Read the detailed description
OSAS patients are required to fill in questionnaire.And Inflammation biomarkers and Oxidative Stress biomarkers and ultrasonic will be tested.Then patients are randomly allocated to one of two groups. One group is treated with oral intake of Antioxidant Carbocysteine 500mg tid. The second group is treated with CPAP. After 6 weeks treatment, all patients will take the overnight polysomnogram test again, and take questionnaire, blood , ultrasonic test.
- Conditions
- Obstructive Sleep Apnoea
- Being tested
- Carbocysteine, Continuous Positive Airway Pressure
- Keywords
- Obstructive sleep apnoea, Antioxidant, drug treatment, oxidative stress, Continuous Positive Airway Pressure
- 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.
CarbocysteineDrug
Also called S-Carboxymethylcysteine; SCMC
carbocisteine (2×250 mg, three times daily) for 6 weeks. The tablets are provided by Baiyunshan Pharmaceutical, China. patients will interviewed after 3 weeks to check their adherence to the study regimen by collecting and counting the number of remaining tablets, record adverse events, and refill study tablets for the next 3 weeks.
Continuous Positive Airway PressureDevice
Also called Nasal Continuous Positive Airway Pressure
Patients will interviewed after 3 weeks and the end of trial.We will check their compliance to device memory download , record adverse events and pressure .
| Study group | Role | What they receive |
|---|---|---|
| Carbocysteine | Experimental | Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day) Receives: Drug: Carbocysteine |
| Continuous Positive Airway Pressure | Active comparator | Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight. Receives: Device: Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment
The Carbocysteine group will oral intake of Carbocysteine 500mg,tid for 6 weeks.We will examine the compliance with the drugs by Recycling the rest of the tablets.We compare the improvement of PSG parameters,such as AHI ,oxygen desaturation index(ODI),oxyhemoglobin saturation.
Measured: after 6 weeks
Daytime sleepiness(EDS) after oral intake of Carbocysteine treatment
EDS is evaluated by Epworth Sleeping Scale(ESS) grade.ESS≥9 means EDS.The higher the ESS, the more daytime sleepiness they feel.
Measured: after 6 weeks
Change of Oxidative Stress after oral intake of Carbocysteine treatment
Biomarkers is measured from venous blood.The blood is collected in the morning .After centrifugation ,the supernatant was kept at -80 degree centigrade.
Measured: after 6 weeks
Secondary outcomes (1)
Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment .
We will examine the compliance with CPAP device memory download.We will compare the two group by the PSG parameters ,ESS, and Biomarkers .
Measured: after 6 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApnoeaStudies 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Institute of Respiratory Disease
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kang Wu, Guangzhou Institute of Respiratory Disease
- Investigators
- NuoFu Zhang, professor, Principal investigator, Guangzhou Institute of Respiratory Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015598
- Sponsor's protocol ID
- IRD201319
- Status last verified
- Jan 2015
- First submitted
- 10 Dec 2013
- Last updated
- 7 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wu K, Su X, Li G, Zhang N. Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial. PLoS One. 2016 Feb 5;11(2):e0148519. doi: 10.1371/journal.pone.0148519. eCollection 2016.
PubMed 26849119
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Oral Intake of Antioxidant Carbocysteine and Nasal Continuous Positive Airway Pressure (CPAP) for Treating in Moderate and Severe Obstructive Sleep Apnoea Syndrome Patients : a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02015598
- Acronym / sponsor ID
- IRD201319
- Conditions
- Obstructive Sleep Apnoea
- Keywords
- Obstructive sleep apnoea, Antioxidant, drug treatment, oxidative stress, Continuous Positive Airway Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Guangzhou Institute of Respiratory DiseaseUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 19 Dec 2013 (estimated)
- 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.
Obstructive sleep apnoea syndrome (OSAS) is characterised by repeated episodes of upper airway occlusion during sleep.It can cause cycles of hypoxia reoxygenation. And it was postulated that intermittent hypoxia seems to resemble ischemia-reperfusion.Many study suggest that ischemia-reperfusion represents an oxidative stress causing increased generation of reactive oxygen species, especially superoxide anions.It is one of the most important mechanisms of cardiovascular diseases, including hypertension, coronary artery disease and cerebrovascular accident complication with OSAS.So many individuals approve OSAS is an Oxidative Stress disease.
Continuous positive airway pressure (CPAP) is the first-line of treatment method in moderate/severe OSA.But poor adherence to CPAP treatment is very common.The failure rate with CPAP treatment is more than 50%.So we are searching a new treatment for that patients. Carbocysteine is a antioxidant.It can not only scavenges the free radicals but also replenishes glutathione(GSH)which is has double antioxidant capacity. However, Carbocysteine is cheaper than other which has double antioxidant capacity drugs,such as N-acetylcysteine.The purpose is to evaluate efficacy of oral intake of Antioxidant Carbocysteine witch can reduce oxidative stress and improve the symptom of OSAS.It recover the imbalance in the oxidant-anti-oxidant status may reduce cardiovascular abnormalities in Patients with OSAS.
Detailed description
OSAS patients are required to fill in questionnaire.And Inflammation biomarkers and Oxidative Stress biomarkers and ultrasonic will be tested.Then patients are randomly allocated to one of two groups. One group is treated with oral intake of Antioxidant Carbocysteine 500mg tid. The second group is treated with CPAP. After 6 weeks treatment, all patients will take the overnight polysomnogram test again, and take questionnaire, blood , ultrasonic test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbocysteine | Experimental | Drug: CarbocysteineCarbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day) |
| Continuous Positive Airway Pressure | Active comparator | Device: Continuous Positive Airway PressureContinuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male in an age range of 18 to 65 years
- Obstructive Sleep Apnoea with an Apnea Hypopnea Index (AHI) of greater than or equal to 15 confirmed by polysomnography
- The patient is able to provide consent
- The patient were not receiving therapy for sleep apnoea,such CPAP or surgery.
Key exclusion criteria (9 listed)
- Inability to tolerate Carbocysteine or CPAP
- Treatment with CPAP or surgery prior to or at the time of enrolment
- presence of active acute or chronic infection
- Patients with unstable cardiovascular diseases (unstable angina, myocardial infarction, stroke, or transient ischemic attacks), neuromuscular diseases, chronic respiratory diseases, peripheral vascular disease
- Using of steroidal , nonsteroidal anti-inflammatory, vasodilators ,lipid-lowering drugs,or other medications that lower oxidative stress.
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 |
|---|---|---|
| CarbocysteineAlso: S-Carboxymethylcysteine; SCMCcarbocisteine (2×250 mg, three times daily) for 6 weeks. The tablets are provided by Baiyunshan Pharmaceutical, China. patients will interviewed after 3 weeks to check their adherence to the study regimen by collecting and counting the number of remaining tablets, record adverse events, and refill study tablets for the next 3 weeks. | Drug | Carbocysteine |
| Continuous Positive Airway PressureAlso: Nasal Continuous Positive Airway PressurePatients will interviewed after 3 weeks and the end of trial.We will check their compliance to device memory download , record adverse events and pressure . | Device | Continuous Positive Airway Pressure |
Primary outcome
Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment
Time frame: after 6 weeks
The Carbocysteine group will oral intake of Carbocysteine 500mg,tid for 6 weeks.We will examine the compliance with the drugs by Recycling the rest of the tablets.We compare the improvement of PSG parameters,such as AHI ,oxygen desaturation index(ODI),oxyhemoglobin saturation.
Daytime sleepiness(EDS) after oral intake of Carbocysteine treatment
Time frame: after 6 weeks
EDS is evaluated by Epworth Sleeping Scale(ESS) grade.ESS≥9 means EDS.The higher the ESS, the more daytime sleepiness they feel.
Change of Oxidative Stress after oral intake of Carbocysteine treatment
Time frame: after 6 weeks
Biomarkers is measured from venous blood.The blood is collected in the morning .After centrifugation ,the supernatant was kept at -80 degree centigrade.
1 secondary outcome
Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment .
Time frame: after 6 weeks treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2015.
- Derived from this study: PubMed 26849119Wu K, Su X, Li G, Zhang N. Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial. PLoS One. 2016 Feb 5;11(2):e0148519. doi: 10.1371/journal.pone.0148519. eCollection 2016.
Related trials for Obstructive Sleep Apnoea
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
NuoFu Zhang, professor principal investigator
Guangzhou Institute of Respiratory Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbocysteine and Continuous Positive Airway Pressure in people with Obstructive Sleep Apnoea, run by Guangzhou Institute of Respiratory Disease 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 7 Jan 2015. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment (time frame: after 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015598, which also lists 1 linked publication.
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 7 Jan 2015.