Sleep Apnea Syndromes Clinical Trial
Official title:
Blood Pressure Reduction Induced by Continuous Positive Airway Pressure (CPAP) in Sleep Apnea Patients at High Cardiovascular Risk : A Randomized Controlled Trial Comparing Usual CPAP Care Versus a Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform
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
telemonitoring arm compared to usual CPAP care.
Main goal:
To compare 6-months blood pressure reduction when Sleep Apnea patients at high
cardiovascular risk are randomly allocated to usual CPAP care or a multidisciplinary and
coordinated follow-up based on a telemonitoring web platform.
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 recorded by actigraphy, CPAP compliance, side effects and residual events.
Secured data transmission to medical staff computers and secured websites will allow easy
telemonitoring. Automatic algorithms have been built-up for early adjustment of CPAP
treatment in case of side effects, leaks and persistent residual events.
An interim analysis will be performed when 300 patients will be included.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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