Status:
UNKNOWN
Blood Pressure Reduction Induced by CPAP in Sleep Apnea Patients at High Cardiovascular Risk : OPTISAS 2 Study
Lead Sponsor:
Fédération Française de Pneumologie
Collaborating Sponsors:
Federation of Medical Specialties
Conditions:
Sleep Apnea Syndromes
High Cardiovascular Risk
Eligibility:
All Genders
18-78 years
Phase:
PHASE4
Brief Summary
Targeted population: Sleep apnea patients at high cardiovascular risk newly treated by CPAP Hypothesis: Improvement in blood pressure after 6 months of CPAP treatment might be greater in the telemo...
Detailed Description
Study procedures: The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of home self-measured blood pressure, oximetry, physical activity ...
Eligibility Criteria
Inclusion
- Age between 18 to 78 years
- Men and women
- AHI \> 30 / hour
- Patient with high cardiovascular score (\>5% defined by European SCORE) or known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- Patient affiliated to the National health insurance
- Willingness to use a telemonitoring system
Exclusion
- Central sleep apnea syndrome
- Previous CPAP treatment with respiratory support for sleep respiratory trouble
- Cardiac failure with left ventricular ejection fraction lesser than 40%
- Hypercapnic chronic respiratory failure (daytime PaCO2 \> 50 mmHg)
- Terminal disease
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
936 Patients enrolled
Trial Details
Trial ID
NCT01505959
Start Date
February 1 2013
End Date
December 1 2014
Last Update
September 5 2014
Active Locations (32)
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1
Respiratory physician in private practice
Albertville, France, 73200
2
Respiratory physician in private practice
Annecy, France, 74000
3
Respiratory physician in private practice
Bordeaux, France, 33000
4
General Hospital
Cannes, France, 06401