Sleep Apnea, Obstructive Clinical Trial
Official title:
A Telemonitoring Crossover Study Comparing a New Incremental Fixed Pressure Titration Modality Versus Auto-adjustable Titration for CPAP-naïve Obstructive Sleep Apnea Patients
This study compares the titration pressures achieved through two auto-titrating modalities, a
new incremental fixed pressure mode versus routine auto-adjusting pressure mode, in
CPAP-naïve obstructive sleep apnea patients.
The aim of the study is to verify that this new modality achieves a lower titration pressure.
In patients with obstructive sleep apnea (OSA) on CPAP treatment, a CPAP titration test is
usually performed to achieve the optimal pressure to maintain upper airway patency, abolish
obstructive respiratory events and reduce the occurrence of adverse events. This pressure is
called titration pressure.
Until now, we used to perform, after an adaptation period, a single-night outpatient test
with an automated device preset on auto-adjusting pressure modality (APAP).
The incremental fixed pressure modality (EZ START) was initially developed to ease patients
into having a positive sleep therapy experience from the very beginning. This mode gradually
increases air pressure night-by-night until the preset therapeutic pressure is reached. In
each good therapy session, the device performs in fixed pressure overnight and we get a real
residual apnea-hypopnea index (rAHI).
For this study, we will use the same device (DreamStation auto CPAP, Philips Respironics,
Murrysville, PA, USA), a web-based system to telemonitor patient therapy (EncoreAnywhere) and
perform for each individual patient the two modalities in a telemonitoring crossover
randomized single-blind (patient) way.
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