Sleep Apnea Syndrome Clinical Trial
Official title:
Multidisciplinary and Coordinated Follow-up Based on a Telemonitoring Web Platform for Improving Continuous Positive Airway Pressure (CPAP) Compliance in Low Cardiovascular Risk Sleep Apnea Patients
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
care.
Main goal:
To compare 6-months CPAP compliance when Sleep Apnea patients at low 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 oximetry, 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 200 patients will be included.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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