Air Leakage Under Continuous Positive Airway Pressure

NCT03381508 | Completed

• 1 other identifier: RECHMPL17_0429
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 3

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

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

CPAP; masks; unintentional leak; leakage

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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 Outcomes (10)

• 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)

Study Arms (1)

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

Interventions

Brizzy continuous positive pressure device DEVICE

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

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

Polyclinic Saint-Privat

Boujan-sur-Libron, 34760, France

Location

University Hospital of Grenoble

Grenoble, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, France

Location

Related 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.

  PMID: 28847549 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.

  PMID: 32544491 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jean-Christian Borel, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

• Nicolas Molinari, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: January 10, 2018
• Primary Completion: April 20, 2018
• Study Completion: April 20, 2018
• Last Updated: July 2, 2020

Record last verified: 2020-06

Locations

FR (3)