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

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ClinicalTrials.gov Identifier: NCT03381508
Recruitment Status : Completed
First Posted : December 22, 2017
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

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


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome 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
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure
Actual Study Start Date : January 10, 2018
Actual Primary Completion Date : April 20, 2018
Actual Study Completion Date : April 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03381508


Locations
France
Polyclinic Saint-Privat
Boujan sur Libron, France, 34760
University Hospital of Grenoble
Grenoble, France
Hôpital Arnaud de Villeneuve
Montpellier, France
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Principal Investigator: Jean-Christian Borel, PhD University Hospital, Grenoble
Study Director: Nicolas Molinari, PhD University Hospital, Montpellier

Publications:
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03381508     History of Changes
Other Study ID Numbers: RECHMPL17_0429
First Posted: December 22, 2017    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Montpellier:
CPAP
masks
unintentional leak
leakage

Additional relevant MeSH terms:
Syndrome
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases