Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome
Condition: Obstructive Sleep Apnoea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

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 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.
    

Intervention name(s): Carbocysteine; Continuous Positive Airway Pressure
Intervention type(s): Drug; Device
Intervention description(s): 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.; 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 intervention name(s): S-Carboxymethylcysteine; SCMC; Nasal Continuous Positive Airway Pressure
Intervention MeSH terms: Carbocysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Obstructive sleep apnoea; Antioxidant; drug treatment; oxidative stress; Continuous Positive Airway Pressure