Clinical trial NCT03381508: Air Leakage Under Continuous Positive Airway Pressure
Official title: Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea Syndrome
Keywords: CPAP
masks
unintentional leak
leakage
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Sleep recordings from patients with OSA treated via auto-CPAP and monitored with Brizzy® device (including measures of non-intentional leaks) between June 1st and December 31th, 2017.

Exclusion Criteria:

* The patient opposes the usage of his/her data
* Minors or adults under any kind of guardianship
* Fixed pressure
* Bilevel positive airway pressure devices
* Adaptive servo-ventilation

Primary outcomes:
measure: Mouth-opening odds ratio
timeFrame: day 0 (transversal study)
measure: Auto-CPAP pressure level odds ratio
timeFrame: day 0 (transversal study)
measure: Sleep position odds ratio
timeFrame: day 0 (transversal study)
measure: Respiratory effort (increase in the Jawac signal > 0.3 mm) odds ratio
timeFrame: day 0 (transversal study)
Secondary outcomes:
measure: Epworth scale score
timeFrame: day 0 (transversal study)
measure: Pichot scale
timeFrame: day 0 (transversal study)
measure: Occurrence of nasal obstruction
timeFrame: day 0 (transversal study)
measure: Occurrence of mouth dryness
timeFrame: day 0 (transversal study)
measure: Occurrence of nasal dryness
timeFrame: day 0 (transversal study)
Other outcomes:
measure: Type/brand of mask and device used
timeFrame: day 0 (transversal study)
measure: Presence of heated humidifier
timeFrame: day 0 (transversal study)
measure: Presence of chinstraps.
timeFrame: day 0 (transversal study)
measure: The Brizzy output
timeFrame: day 0 (transversal study)
measure: Mask pressure as measured by Brizzy
timeFrame: day 0 (transversal study)
measure: Presence/absence of technical problems that arise in relation to the analysis of leaks
timeFrame: day 0 (transversal study)
measure: Presence/absence of a comorbidity
timeFrame: day 0 (transversal study)
measure: Presence of a psychotropic treatment
timeFrame: day 0 (transversal study)
measure: Presence of a treatment of nasal problem
timeFrame: day 0 (transversal study)
measure: Anterior ORL surgery
timeFrame: day 0 (transversal study)
Locations:
city: Boujan sur Libron
country: France
facility: Polyclinic Saint-Privat
city: Grenoble
country: France
facility: University Hospital of Grenoble
city: Montpellier
country: France
facility: Hôpital Arnaud de Villeneuve
Study officials:
affiliation: University Hospital, Grenoble
name: Jean-Christian Borel, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Montpellier
name: Nicolas Molinari, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.