Brizzy continuous positive pressure device
DevicePatients are treated with the Brizzy continuous positive pressure device, including pneumotachograph.
NCT Number: NCT03381508
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
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Notify Me18 year and older
All sexes
Observational
Polyclinic Saint-Privat, Boujan-sur-Libron, France
The secondary objectives are:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients are treated with the Brizzy continuous positive pressure device, including pneumotachograph.
Time frame: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.
Time frame: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios for Auto-CPAP pressure level
Time frame: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios for sleep position
Time frame: day 0 (transversal study)
For each patient presenting with an unintentional leak, determination of odds ratios respiratory effort
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
Time frame: day 0 (transversal study)
University Hospital, Montpellier
Other
Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure
Acronym: SAS-leak-1
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