NCT02015598

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

Completed NA Last updated 6 January 2015

What this trial tests

NA trial testing Carbocysteine in Obstructive Sleep Apnoea in 40 participants. Completed in 1 May 2014.

Timeline

1 December 2013

Primary endpoint
1 May 2014

1 May 2014

Quick facts

Lead sponsor	Guangzhou Institute of Respiratory Disease
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	1 December 2013
Primary completion	1 May 2014
Estimated completion	1 May 2014
Sites	1 location across China

Drugs / interventions tested

• Carbocysteine (carbocysteine) — full drug profile →
• Continuous Positive Airway Pressure

Conditions studied

• Obstructive Sleep Apnoea — all drugs for Obstructive Sleep Apnoea →

Sponsor

Guangzhou Institute of Respiratory Disease

Who can join

Adults 18 to 65, male only, with Obstructive Sleep Apnoea. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial.
   Wu K, Su X, Li G, Zhang N. · · 2016 · cited 15× · PMID 26849119 · DOI 10.1371/journal.pone.0148519