Air Leakage Under Continuous Positive Airway Pressure (SAS-leak-1)

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

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Brizzy continuous positive pressure 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.

• Study Type: Observational
• Enrollment (Actual): 79

Contacts and Locations

Study Locations

• France
  • Boujan sur Libron, France, 34760
    • Polyclinic Saint-Privat
  • Grenoble, France
    • University hospital of Grenoble
  • Montpellier, France
    • Hopital Arnaud de Villeneuve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Brizzy continuous positive pressure device; Patients are treated with the Brizzy continuous positive pressure device, including pneumotachograph.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Time Frame
Epworth scale score	day 0 (transversal study)
Pichot scale	day 0 (transversal study)
Occurrence of nasal obstruction	day 0 (transversal study)
Occurrence of mouth dryness	day 0 (transversal study)
Occurrence of nasal dryness	day 0 (transversal study)

Other Outcome Measures

Outcome Measure	Time Frame
Type/brand of mask and device used	day 0 (transversal study)
Presence of heated humidifier	day 0 (transversal study)
Presence of chinstraps.	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)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Jean-Christian Borel, PhD, University Hospital, Grenoble; Study Director: Nicolas Molinari, PhD, University Hospital, Montpellier

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): April 20, 2018
• Study Completion (Actual): April 20, 2018

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 18, 2017
• First Posted (Actual): December 22, 2017

Study Record Updates

• Last Update Posted (Actual): July 2, 2020
• Last Update Submitted That Met QC Criteria: June 30, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: CPAP; masks; unintentional leak; leakage
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Syndrome
• Other Study ID Numbers: RECHMPL17_0429

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No