Effect of Continuous Positive Airway Pressure (CPAP) on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Patients With Sleep Apnea
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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 |
- Blood Pressure measurement [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: David S Hui, MD | 852-26-323-134 | dschui@cuhk.edu.hk |
| 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 | |
| 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 Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Disorders Nervous System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013