Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome

NCT ID: NCT02015598

Last Updated: 2015-01-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2014-05-31

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.

Conditions

Obstructive Sleep Apnoea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Carbocysteine

Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day)

Group Type: EXPERIMENTAL

Carbocysteine

Intervention Type: DRUG

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.

Continuous Positive Airway Pressure

Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight.

Group Type: ACTIVE_COMPARATOR

Continuous Positive Airway Pressure

Intervention Type: DEVICE

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 .

Interventions

Carbocysteine

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.

Intervention Type: DRUG

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 .

Intervention Type: DEVICE

Other Intervention Names

S-Carboxymethylcysteine; SCMC; Nasal Continuous Positive Airway Pressure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: lead

Responsible Party

Kang Wu

master

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

NuoFu Zhang, professor

Role: PRINCIPAL_INVESTIGATOR

Guangzhou Institute of Respiratory Disease

Locations

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, China

Countries

China

References

Wu K, Su X, Li G, Zhang N. Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnea Syndrome: A Randomized Clinical Trial. PLoS One. 2016 Feb 5;11(2):e0148519. doi: 10.1371/journal.pone.0148519. eCollection 2016.

Reference Type: DERIVED

PMID: 26849119 (View on PubMed)

Other Identifiers

IRD201319

Identifier Type: -

Identifier Source: org_study_id