Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome
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.
Obstructive Sleep Apnoea
Device: Continuous Positive Airway Pressure
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment [ Time Frame: after 6 weeks ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]Biomarkers is measured from venous blood.The blood is collected in the morning .After centrifugation ,the supernatant was kept at -80 degree centigrade.
- Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment . [ Time Frame: after 6 weeks treatment ] [ Designated as safety issue: Yes ]We will examine the compliance with CPAP device memory download.We will compare the two group by the PSG parameters ,ESS, and Biomarkers .
- Change of vascular function after oral intake of Antioxidant Carbocysteine [ Time Frame: after 6 weeks after oral intake of Carbocysteine treatment ] [ Designated as safety issue: Yes ]Vasoreactivity Testing Protocol and intima-media thickness is measured by high-resolution ultrasonography at baseline and 6 weeks after treatment.Vasoactive mediators from blood will be studied.
|Study Start Date:||February 2013|
|Study Completion Date:||May 2014|
|Primary Completion Date:||February 2014 (Final data collection date for primary outcome measure)|
Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day)
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.
Other Name: S-Carboxymethylcysteine; SCMC
Active Comparator: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight.
Device: 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 .
Other Name: Nasal Continuous Positive Airway Pressure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02015598
|Guangzhou institute of respiratory disease|
|Guangzhou,, Guangdong, China, 510120|
|Principal Investigator:||NuoFu Zhang, professor||Guangzhou Institute of Respiratory Disease|