Effect of Continuous Positive Airway Pressure (CPAP) on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Patients With Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Chinese University of Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00300599
First received: March 8, 2006
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5 times per hour. Sleep-disordered breathing affects 9 to 24% of the middle-aged and overall 4% of the middle-aged males suffers from Obstructive sleep apnea syndrome (OSAS) i.e. SDB with associated daytime sleepiness. Several major epidemiological studies have shown that SDB is not only an independent risk factor for systemic hypertension but it is also associated with cardiovascular complications such as heart failure, stroke, and sudden death.

The mechanisms for the linkage between Sleep-disordered breathing and cardiovascular diseases are not fully determined but surges in sympathetic nerve activity are seen at the end of each apneic episode accompanied by large rises in systemic arterial blood pressure (BP). The increased levels of muscle sympathetic nerve activity are diminished by nasal continuous positive airway pressure (CPAP) therapy. Numerous studies have found a hypercoagulable state in terms of increased clotting factor and platelet activities, and impaired fibrinolysis in coronary artery disease, ischaemic stroke, and sleep-disordered breathing. Common carotid artery intima-media thickness (IMT) has been shown to correlate with traditional vascular risk factors and may predict the likelihood of acute coronary events and stroke. Recently, carotid artery intima-media thickness has been shown to have positive correlations with the severity of sleep disordered breathing.

Despite robust evidence showing improvement of symptoms, cognitive function and quality of life in patients with obstructive sleep apnea treated with nasal continuous positive airway pressure, there are conflicting short-term data whether continuous positive airway pressure can reduce blood pressure in patients with obstructive sleep apnea. This randomized controlled study aims to assess the long-term effects of nasal continuous positive airway pressure on 1) 24 hr systemic blood pressure; 2) Coagulation state; and 3) Carotid artery intimal media thickness.


Condition Intervention
Obstructive Sleep Apnoea
Device: Continuous Positive Airway pressure
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Study of the Long-term Effects of Nasal Continuous Positive Airway Pressure on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Blood Pressure measurement [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in systolic and diastolic Blood pressure between the 2 groups at 6 & 12 months [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • serial changes of carotid intimal media thickness between the two treatment groups over 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • serial changes in haemostatic assays [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Continue positive airway pressure
Device: Continuous Positive Airway pressure
Continuous positive pressure device with a time clock
Placebo Comparator: B
Placebo
Other: Placebo
Placebo

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 20 to 80 yrs
  • Apnoea Hypopnea index ≥5/hr on Polysomnography with Epworth Sleepiness Scale ≥10

Exclusion Criteria:

  • Predominantly central sleep apnoea
  • Recent myocardial infarction 3 months before the study
  • Unstable angina
  • Underlying malignancy
  • Professional drivers and those handling dangerous machinery
  • Patients will be considered dropouts if anti-hypertensive medication is accidentally changed by the patients or their general practitioners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00300599

Contacts
Contact: David S Hui, MD 852-26-323-134 dschui@cuhk.edu.hk

Locations
Hong Kong
The Chinese University of Hong Kong Recruiting
Hong Kong, New Territories, Hong Kong
Contact: David S Hui, MD    852-26-323-135    dschui@cuhk.edu.hk   
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: David S Hui, MD Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Dr. David SC Hui, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00300599     History of Changes
Other Study ID Numbers: Resp/hui/2006/001
Study First Received: March 8, 2006
Last Updated: June 22, 2011
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 23, 2014