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Effect of Nasal Continuous Positive Airway Pressure (CPAP) Blood Pressure and Vascular Endothelial Growth Factor in Obstructive Sleep Apnoea Syndrome
This study is currently recruiting participants.
Verified by Chinese University of Hong Kong, May 2008
Sponsored by: Chinese University of Hong Kong
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00300872
  Purpose

Sleep-disordered breathing (SDB) briefly means cessation of breathing during sleep at least 5 times per hour. SDB is a common disorder affecting 9 to 24% of the middle-aged and overall 4% of the middle-aged male population suffers from the Obstructive sleep apnoea syndrome (OSA) i.e. SDB with associated daytime sleepiness. Several major epidemiological studies have shown that SDB is not only an independent risk factor for hypertension but it is also strongly associated with heart failure and stroke. The mechanism for the linkage between SDB and cardiovascular consequences is not fully determined. Vascular endothelial growth factor (VEGF) is a soluble 34-46 kD angiogenic heparin-binding glycoprotein. This cytokine regulates multiple endothelial cell functions including vascular permeability and vascular tone and some data suggest that it may contribute to the atherosclerotic process. Recent studies have shown increased plasma and serum concentrations of VEGF in patients with OSA and there were correlations between VEGF concentrations and the severity of OSA, as indexed by the minimum oxygen saturation level and the frequency of the upper airway obstruction per hour of sleep. A recent non-randomised study with a small sample size has shown a significant decrease in VEGF concentrations in patients in whom nocturnal hypoxia improved after 1 year of nasal continuous positive airway pressure (CPAP) therapy.

Despite robust evidence showing improvement of symptoms, cognitive function and quality of life in OSA patients treated with nasal CPAP, there are nevertheless conflicting data whether CPAP can reduce daytime blood pressure (BP) in patients with OSA. Two randomized placebo controlled studies have shown reduction of 24-hr systolic and diastolic BP in OSA patients after 1 month of nasal CPAP therapy while other investigators have shown no such benefit.

This randomized, sham-placebo controlled study aims to assess 1) the effect of nasal CPAP over a period of 3 months on 24 hr BP; and 2) whether any change in BP and plasma VEGF is related to the baseline severity of OSA and CPAP compliance.


Condition Intervention
Obstructive Sleep Apnoea
Device: CPAP
Device: Sham CPAP

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title: A Randomized, Placebo-Controlled Study of the Medium-Term Effect of Nasal CPAP on 24 Hour Blood Pressure and Vascular Endothelial Growth Factor in Obstructive Sleep Apnoea Syndrome

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

Primary Outcome Measures:
  • Change in 24 hr mean BP at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in systolic and diastolic BP, changes in mean BP awake and asleep, change in plasma VEGF at 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • Whether any change in BP or VEGF is related to the baseline severity of OSA and CPAP compliance over 3 months [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]
  • ESS and SAQLI at 1 month and 3 months. [ Time Frame: baseline and 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: January 2005
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
CPAP
Device: CPAP
CPAP
2: Sham Comparator
Sham CPAP
Device: Sham CPAP
Sham CPAP

  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, AHI >10/hr on PSG with symptoms of OSA as described previously, and ESS >10.
  • Patients with hypertension will still be eligible to enter and continue the study as long as there is no alteration of anti-hypertensive medications during the study period

Exclusion Criteria:

  • Patients having problems staying awake during driving, shift work, recent myocardial infarction, unstable angina, and underlying malignancy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300872

Contacts
Contact: David S Hui, MD 852 26323135 dschui@cuhk.edu.hk

Locations
Hong Kong, New Territories
The Chinese University of Hong Kong Recruiting
Shatin, New Territories, Hong Kong
Contact: David S Hui, MD     852 26323135     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

Responsible Party: The Chinese University of Hong Kong ( Dr. David SC Hui )
Study ID Numbers: Resp/hui/2006/002
Study First Received: March 8, 2006
Last Updated: May 6, 2008
ClinicalTrials.gov Identifier: NCT00300872  
Health Authority: Hong Kong: Department of Health

Study placed in the following topic categories:
Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive
Dyssomnias
Sleep Disorders
Signs and Symptoms, Respiratory
Endothelial Growth Factors
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Growth Substances
Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009