Antioxidant Carbocysteine Treatment in Obstructive Sleep Apnoea Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kang Wu, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier:
NCT02015598
First received: December 10, 2013
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Obstructive Sleep Apnoea
Drug: Carbocysteine
Device: Continuous Positive Airway Pressure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Guangzhou Institute of Respiratory Disease:

Primary Outcome Measures:
  • Change of polysomnography (PSG) parameters after oral intake of Carbocysteine treatment [ Time Frame: after 6 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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:
  • Evaluate efficacy of oral intake of Antioxidant Carbocysteine in comparison to Nasal continuous positive airway pressure (CPAP) treatment . [ Time Frame: after 6 weeks treatment ] [ Designated as safety issue: Yes ]
    We will examine the compliance with CPAP device memory download.We will compare the two group by the PSG parameters ,ESS, and Biomarkers .


Other Outcome Measures:
  • Change of vascular function after oral intake of Antioxidant Carbocysteine [ Time Frame: after 6 weeks after oral intake of Carbocysteine treatment ] [ Designated as safety issue: Yes ]
    Vasoreactivity Testing Protocol and intima-media thickness is measured by high-resolution ultrasonography at baseline and 6 weeks after treatment.Vasoactive mediators from blood will be studied.


Enrollment: 40
Study Start Date: February 2013
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carbocysteine
Carbocysteine , tablet ,250mg per one tablet , patients oral intake with 500mg .tid.(1500mg/day)
Drug: 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.
Other Name: S-Carboxymethylcysteine; SCMC
Active Comparator: Continuous Positive Airway Pressure
Continuous Positive Airway Pressure(CPAP),auto-CPAP(USA,Philips), patients use Nasal CPAP overnight.
Device: 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 .
Other Name: Nasal Continuous Positive Airway Pressure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02015598

Locations
China, Guangdong
Guangzhou institute of respiratory disease
Guangzhou,, Guangdong, China, 510120
Sponsors and Collaborators
Guangzhou Institute of Respiratory Disease
Investigators
Principal Investigator: NuoFu Zhang, professor Guangzhou Institute of Respiratory Disease
  More Information

No publications provided

Responsible Party: Kang Wu, master, Guangzhou Institute of Respiratory Disease
ClinicalTrials.gov Identifier: NCT02015598     History of Changes
Other Study ID Numbers: IRD201319
Study First Received: December 10, 2013
Last Updated: August 11, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Guangzhou Institute of Respiratory Disease:
Obstructive sleep apnoea
Antioxidant
drug treatment
oxidative stress
Continuous Positive Airway Pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Antioxidants
Carbocysteine
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on October 19, 2014