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Air Leakage Under Continuous Positive Airway Pressure

Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03381508
Acronym
SAS-leak-1
Enrollment
79
Registered
2017-12-22
Start date
2018-01-10
Completion date
2018-04-20
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

CPAP, masks, unintentional leak, leakage

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.

Interventions

DEVICEBrizzy continuous positive pressure device

Patients are treated with the Brizzy continuous positive pressure device, including pneumotachograph.

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mouth-opening odds ratioday 0 (transversal study)For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.
Auto-CPAP pressure level odds ratioday 0 (transversal study)For each patient presenting with an unintentional leak, determination of odds ratios for Auto-CPAP pressure level
Sleep position odds ratioday 0 (transversal study)For each patient presenting with an unintentional leak, determination of odds ratios for sleep position
Respiratory effort (increase in the Jawac signal > 0.3 mm) odds ratioday 0 (transversal study)For each patient presenting with an unintentional leak, determination of odds ratios respiratory effort

Secondary

MeasureTime frame
Epworth scale scoreday 0 (transversal study)
Pichot scaleday 0 (transversal study)
Occurrence of nasal obstructionday 0 (transversal study)
Occurrence of mouth drynessday 0 (transversal study)
Occurrence of nasal drynessday 0 (transversal study)

Other

MeasureTime frame
Type/brand of mask and device usedday 0 (transversal study)
Anterior ORL surgeryday 0 (transversal study)
Presence of heated humidifierday 0 (transversal study)
Presence of chinstraps.day 0 (transversal study)
The Brizzy outputday 0 (transversal study)
Mask pressure as measured by Brizzyday 0 (transversal study)
Presence/absence of technical problems that arise in relation to the analysis of leaksday 0 (transversal study)
Presence/absence of a comorbidityday 0 (transversal study)
Presence of a psychotropic treatmentday 0 (transversal study)
Presence of a treatment of nasal problemday 0 (transversal study)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026