Status:
UNKNOWN
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving CPAP Compliance in Low Cardiovascular Risk Sleep Apnea Patients : OPTISAS 1 Study
Lead Sponsor:
Fédération Française de Pneumologie
Collaborating Sponsors:
Federation of Medical Specialties
Conditions:
Sleep Apnea Syndrome
Low Cardiovascular Risk
Eligibility:
All Genders
18-78 years
Phase:
PHASE4
Brief Summary
Targeted population: Sleep apnea patients at low cardiovascular risk newly treated by CPAP Hypothesis: Six months CPAP compliance might be greater in the telemonitoring arm compared to usual CPAP c...
Detailed Description
Study procedures: The telemonitoring system will involve respiratory physicians, home care providers and include regular assessments of oximetry, CPAP compliance, side effects and residual events. S...
Eligibility Criteria
Inclusion
- Age between 18 to 78 years
- Men and women
- AHI \> 30 / hour
- Patient with low cardiovascular score (\<5% defined by European SCORE)
- Patient affiliated to the national health insurance
- Willingness to use a telemonitoring system
Exclusion
- Known cardiovascular disease (i.e. transient ischemic attack, stroke, coronary artery disease)
- Central sleep apnea syndrome
- Previous CPAP treatment with respiratory support for sleep respiratory trouble
- Cardiac failure
- 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
NCT01796769
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