Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study
We hypothesize that the use of telemedicine combined with support interventions by short
messages, telephone calls and ambulatory visits to control CPAP treatment during the first
month improves adherence and reduces unresolved side effects of therapy.
The primary objective of an OSAS treatment program is to successfully implement indicated
CPAP in the highest possible proportion of patients in order to lower the proportion of
untreated OSAS in the population. On an individual basis, it has been shown that a longer
duration of CPAP use is associated with better outcomes in terms of daytime functioning and
in the control of metabolic and blood pressure effects of CPAP. For our study, we have
therefore decided to use 2 co-primary endpoints, taking into account both aspects of
adherence mentioned. Cardiovascular complications are a major concern in OSAS patients.
Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk.
We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive
impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of
treatment.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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