An interventional study of Carbocysteine and Continuous Positive Airway Pressure in Obstructive Sleep Apnoea, sponsored by Guangzhou Institute of Respiratory Disease. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-01-07.
Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Treatment
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.
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.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 40 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Guangzhou Institute of Respiratory Disease is the lead sponsor of 99 studies on the registry; 18 are open to participants now.
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Exclusion Criteria:
Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day)
Drug: Carbocysteine
Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight.
Device: Continuous Positive Airway Pressure
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.
Also known as: S-Carboxymethylcysteine; SCMC
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 .
Also known as: Nasal Continuous Positive Airway Pressure
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.
Time frame: 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.
Time frame: 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.
Time frame: after 6 weeks
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 .
Time frame: after 6 weeks treatment
Change of vascular function after oral intake of Antioxidant Carbocysteine
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.
Time frame: after 6 weeks after oral intake of Carbocysteine treatment
The record gives a start of Dec 2013, a primary completion of May 2014 and a completion of May 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Carbocysteine
Guangzhou Institute of Respiratory Disease