Obstructive Sleep Apnea Syndrome Clinical Trial
Official title:
Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure
The software embedded in recent continuous positive pressure devices enables the analysis of
the level of leakage that occurs during treatment around the mask or from the mouth. However,
there is no clear threshold defining when it would be appropriate to implement means for
correcting these leaks. In addition, the calculation methods used to detect/measure leaks and
the terminology used vary according to the manufacturers of continuous pressure devices,
which also complicates the clinical interpretation of the leakage reports provided by the
various devices.
In daily practice, when a patient complains of unintentional leakage, technicians adjust the
mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. Nevertheless, those
strategies are not always effective in reducing leakage or patient's complaints. A better
understanding of the mechanisms beyond leak appearance for a given patient could lead to
individualised leak-treatment solutions. Pressure level, mandibular behaviour, respiratory
effort, sleep position or sleep stages may contribute to leak emergence.
A recent exploratory study has proposed a genuine analysis method of determining factors of
unintentional-leaks using polysomnographic recordings in OSA patients treated with automatic
Continuous Positive Airway Pressure (auto-CPAP). Based on the same methodology, the NOMICS
company (Liège, Belgium) has developed a polygraphic device (Brizzy®) recording unintentional
leakage during auto-CPAP treatment and providing an etiological analysis of
unintentional-leaks via a software named APIOS.
Due to the innovative nature of the analysis, it appears necessary to validate it onto a
population of OSA patients treated with auto-CPAP. Also, to our knowledge, there is no
descriptive data of the distribution of the determinants of unintentional leaks in such a
population. From this perspective, the investigators aim to retrospectively analyse some
polygraphic recordings that have been performed with the Brizzy® on OSA patients treated with
auto-CPAP.
The primary objective of this study is to identify and describe the determinants of
unintentional leaks for a population of patients with OSA and treated with an auto-CPAP
device
The secondary objectives are:
1. to evaluate the concordance of the determinants of leaks according to different leak
thresholds (0 l/min ; 5l/min ; 10l/min : 20l/min).
2. to describe any technical problems that arise in relation to the analysis of leaks in
the study population.
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