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Completed

NCT Number: NCT03381508

Air Leakage Under 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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinic Saint-Privat, Boujan-sur-Libron, France

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About this study

The secondary objectives are:

  • to evaluate the concordance of the determinants of leaks according to different leak thresholds (0 l/min ; 5l/min ; 10l/min : 20l/min).
  • to describe any technical problems that arise in relation to the analysis of leaks in the study population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brizzy continuous positive pressure device

Device

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

Primary outcomes

  1. Mouth-opening odds ratio

    Time frame: day 0 (transversal study)

    For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.

  2. Auto-CPAP pressure level odds ratio

    Time frame: day 0 (transversal study)

    For each patient presenting with an unintentional leak, determination of odds ratios for Auto-CPAP pressure level

  3. Sleep position odds ratio

    Time frame: day 0 (transversal study)

    For each patient presenting with an unintentional leak, determination of odds ratios for sleep position

  4. Respiratory effort (increase in the Jawac signal > 0.3 mm) odds ratio

    Time frame: day 0 (transversal study)

    For each patient presenting with an unintentional leak, determination of odds ratios respiratory effort

Secondary outcomes

  1. Epworth scale score

    Time frame: day 0 (transversal study)

  2. Pichot scale

    Time frame: day 0 (transversal study)

  3. Occurrence of nasal obstruction

    Time frame: day 0 (transversal study)

  4. Occurrence of mouth dryness

    Time frame: day 0 (transversal study)

  5. Occurrence of nasal dryness

    Time frame: day 0 (transversal study)

Other outcomes

  1. Type/brand of mask and device used

    Time frame: day 0 (transversal study)

  2. Presence of heated humidifier

    Time frame: day 0 (transversal study)

  3. Presence of chinstraps.

    Time frame: day 0 (transversal study)

  4. The Brizzy output

    Time frame: day 0 (transversal study)

  5. Mask pressure as measured by Brizzy

    Time frame: day 0 (transversal study)

  6. Presence/absence of technical problems that arise in relation to the analysis of leaks

    Time frame: day 0 (transversal study)

  7. Presence/absence of a comorbidity

    Time frame: day 0 (transversal study)

  8. Presence of a psychotropic treatment

    Time frame: day 0 (transversal study)

  9. Presence of a treatment of nasal problem

    Time frame: day 0 (transversal study)

  10. Anterior ORL surgery

    Time frame: day 0 (transversal study)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: SAS-leak-1

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 22, 2017
Registry last updated
Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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