Air Leakage Under Continuous Positive Airway Pressure

Obstructive Sleep Apnea Syndrome Clinical Trial

— SAS-leak-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03381508
• Other study ID #: RECHMPL17_0429
• Status: Completed
• Start date: January 10, 2018
• Est. completion date: April 20, 2018

Study information

• Verified date: June 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 20, 2018
• Est. primary completion date: April 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

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

Locations

Country	Name	City	State
France	Polyclinic Saint-Privat	Boujan sur Libron
France	University Hospital of Grenoble	Grenoble
France	Hôpital Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

Lebret M, Jaffuel D, Suehs CM, Mallet JP, Lambert L, Rotty MC, Pépin JL, Matzner-Lober E, Molinari N, Borel JC. Feasibility of type 3 polygraphy for evaluating leak determinants in CPAP-treated OSA patients: a step towards personalized leak management. Ch — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Type/brand of mask and device used		day 0 (transversal study)
Other	Presence of heated humidifier		day 0 (transversal study)
Other	Presence of chinstraps.		day 0 (transversal study)
Other	The Brizzy output		day 0 (transversal study)
Other	Mask pressure as measured by Brizzy		day 0 (transversal study)
Other	Presence/absence of technical problems that arise in relation to the analysis of leaks		day 0 (transversal study)
Other	Presence/absence of a comorbidity		day 0 (transversal study)
Other	Presence of a psychotropic treatment		day 0 (transversal study)
Other	Presence of a treatment of nasal problem		day 0 (transversal study)
Other	Anterior ORL surgery		day 0 (transversal study)
Primary	Mouth-opening odds ratio	For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.	day 0 (transversal study)
Primary	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)
Primary	Sleep position odds ratio	For each patient presenting with an unintentional leak, determination of odds ratios for sleep position	day 0 (transversal study)
Primary	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	Epworth scale score		day 0 (transversal study)
Secondary	Pichot scale		day 0 (transversal study)
Secondary	Occurrence of nasal obstruction		day 0 (transversal study)
Secondary	Occurrence of mouth dryness		day 0 (transversal study)
Secondary	Occurrence of nasal dryness		day 0 (transversal study)