Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome

NCT02015598 | Completed

• 1 other identifier: IRD201319
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnoea

Keywords

Obstructive sleep apnoea; Antioxidant; drug treatment; oxidative stress; Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  after 6 weeks

Secondary Outcomes (1)

• Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment .

  after 6 weeks treatment

Other Outcomes (1)

• Change of vascular function after oral intake of Antioxidant Carbocysteine

  after 6 weeks after oral intake of Carbocysteine treatment

Study Arms (2)

Carbocysteine

EXPERIMENTAL

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

Drug: Carbocysteine

Continuous Positive Airway Pressure

ACTIVE COMPARATOR

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

Device: Continuous Positive Airway Pressure

Interventions

Carbocysteine 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.

Also known as: S-Carboxymethylcysteine; SCMC

Carbocysteine

Continuous Positive Airway Pressure 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 .

Also known as: Nasal Continuous Positive Airway Pressure

Continuous Positive Airway Pressure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Guangzhou Institute of Respiratory Disease: lead

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location

Related Publications (1)

• 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.

  PMID: 26849119 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Carbocysteine; Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids, Dicarboxylic; Amino Acids; Amino Acids, Peptides, and Proteins; Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• NuoFu Zhang, professor

  Guangzhou Institute of Respiratory Disease

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 19, 2013
• Study Start: December 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 7, 2015

Record last verified: 2015-01

Locations

CN (1)