Sleep Apnea, Obstructive Clinical Trial
Official title:
Usefulness of a Telemedicine System for OSA Patients Follow-up With High Cardiovascular Risk
The aim of this study is to determine the usefulness of a telemedicine system for the follow-up of OSA patients with a high cardiovascular risk. Our hypothesis is that the telemedicine system will enhance compliance and thus reduce self-measured blood pressure.
The obstructive sleep apnea syndrome (OSAS) corresponds to repeated epochs of complete or
incomplete pharynx collapses occurring during sleep. The Continuous Positive Airway Pressure
is the gold standard treatment for OSAS. It consists of air insufflation in upper airways
with a pressure of about 5 to 15 cm of water with a facial or nasal mask. CPAP treatment
reduces cardiovascular morbi-mortality.
OSAS is associated with cardiovascular mortality. A dose response effect exists between
severity and arterial blood pressure. A recent meta-analysis has shown in unselected OSAS
patients with or without hypertension, treated or non-treated for hypertension, CPAP reduces
24 h ambulatory blood pressure of approximately 2 mmHg. This decrease corresponds to a
significant reduction in cardiovascular risk.
The aim of the present study is to include OSAS patients with a high cardiovascular risk and
to measure the effect of CPAP on home measurements of arterial blood pressure. This
controlled randomized trial will compare the effect CPAP on arterial blood pressure in a
group with a telemedicine system versus a group with standard home care CPAP treatment.
An interim analysis will be carried out when 100 patients have been included in the study.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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