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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | The study population corresponds to patients with obstructive sleep apnea syndrome treated via continuous positive pressure and monitored according to usual practice with the latest Brizzy device. Intervention: Brizzy continuous positive pressure device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brizzy continuous positive pressure device | Device | Patients are treated with the Brizzy continuous positive pressure device, including pneumotachograph. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mouth-opening odds ratio | For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening. | day 0 (transversal study) |
| Auto-CPAP pressure level odds ratio | For each patient presenting with an unintentional leak, determination of odds ratios for Auto-CPAP pressure level | day 0 (transversal study) |
| Sleep position odds ratio | For each patient presenting with an unintentional leak, determination of odds ratios for sleep position | day 0 (transversal study) |
| Respiratory effort (increase in the Jawac signal > 0.3 mm) odds ratio | For each patient presenting with an unintentional leak, determination of odds ratios respiratory effort | day 0 (transversal study) |
| Measure | Description | Time Frame |
|---|---|---|
| Epworth scale score | day 0 (transversal study) | |
| Pichot scale | day 0 (transversal study) | |
| Occurrence of nasal obstruction |
| Measure | Description | Time Frame |
|---|---|---|
| Type/brand of mask and device used | day 0 (transversal study) | |
| Presence of heated humidifier | day 0 (transversal study) | |
| Presence of chinstraps. |
Inclusion Criteria:
Exclusion Criteria:
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The study population corresponds to patients (all meeting eligibility criteria) with obstructive sleep apnea syndrome treated via continuous positive pressure and monitored according to usual practice with the latest Brizzy device.
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Christian Borel, PhD | University Hospital, Grenoble | Principal Investigator |
| Nicolas Molinari, PhD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polyclinic Saint-Privat | Boujan-sur-Libron | 34760 | France | |||
| University Hospital of Grenoble |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28847549 | Result | Lebret M, Arnol N, Martinot JB, Lambert L, Tamisier R, Pepin JL, Borel JC. Determinants of Unintentional Leaks During CPAP Treatment in OSA. Chest. 2018 Apr;153(4):834-842. doi: 10.1016/j.chest.2017.08.017. Epub 2017 Aug 26. | |
| 32544491 | Result | Lebret M, Jaffuel D, Suehs CM, Mallet JP, Lambert L, Rotty MC, Pepin JL, Matzner-Lober E, Molinari N, Borel JC. Feasibility of Type 3 Polygraphy for Evaluating Leak Determinants in CPAP-Treated OSA Patients: A Step Toward Personalized Leak Management. Chest. 2020 Nov;158(5):2165-2171. doi: 10.1016/j.chest.2020.05.593. Epub 2020 Jun 13. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| day 0 (transversal study) |
| Occurrence of mouth dryness | day 0 (transversal study) |
| Occurrence of nasal dryness | day 0 (transversal study) |
| day 0 (transversal study) |
| The Brizzy output | day 0 (transversal study) |
| Mask pressure as measured by Brizzy | day 0 (transversal study) |
| Presence/absence of technical problems that arise in relation to the analysis of leaks | day 0 (transversal study) |
| Presence/absence of a comorbidity | day 0 (transversal study) |
| Presence of a psychotropic treatment | day 0 (transversal study) |
| Presence of a treatment of nasal problem | day 0 (transversal study) |
| Anterior ORL surgery | day 0 (transversal study) |
| Grenoble |
| France |
| Hôpital Arnaud de Villeneuve | Montpellier | France |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |