Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnoea
• Interventions: Device: Continuous Positive Airway Pressure; Drug: Carbocysteine

• Registration Number: NCT02015598
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

Brief 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.

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-10
• Study First Submitted QC: 2013-12-18
• Study First Posted: 2013-12-19
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-06
• Last Update Posted: 2015-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

1. Male in an age range of 18 to 65 years
2. Obstructive Sleep Apnoea with an Apnea Hypopnea Index (AHI) of greater than or equal to 15 confirmed by polysomnography
3. The patient is able to provide consent
4. The patient were not receiving therapy for sleep apnoea,such CPAP or surgery.

Exclusion Criteria

1. Inability to tolerate Carbocysteine or CPAP
2. Treatment with CPAP or surgery prior to or at the time of enrolment
3. presence of active acute or chronic infection
4. Patients with unstable cardiovascular diseases (unstable angina, myocardial infarction, stroke, or transient ischemic attacks), neuromuscular diseases, chronic respiratory diseases, peripheral vascular disease
5. Using of steroidal , nonsteroidal anti-inflammatory, vasodilators ,lipid-lowering drugs,or other medications that lower oxidative stress.
6. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
7. Unwilling to participate in the study
8. Participation in another clinical study in the past 4 weeks
9. Shift worker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure	Continuous Positive Airway Pressure	Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight.
Carbocysteine	Carbocysteine	Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day)

Primary Outcome Measures

Name	Time	Method
Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment .	after 6 weeks treatment	We will examine the compliance with CPAP device memory download.We will compare the two group by the PSG parameters ,ESS, and Biomarkers .

Trial Locations

Locations (1)

Guangzhou institute of respiratory disease; 🇨🇳 Guangzhou,, Guangdong, China