An observational study in Obstructive Sleep Apnea Syndrome, sponsored by University Hospital, Montpellier. Completed at 3 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-02.
Sponsored by University Hospital, Montpellier · Observational
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
The secondary objectives are:
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.
Exclusion Criteria:
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.
Mouth-opening odds ratio
For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.
Time frame: 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
Time frame: day 0 (transversal study)
Sleep position odds ratio
For each patient presenting with an unintentional leak, determination of odds ratios for sleep position
Time frame: 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
Time frame: day 0 (transversal study)
Epworth scale score
Time frame: day 0 (transversal study)
Pichot scale
Time frame: day 0 (transversal study)
Occurrence of nasal obstruction
Time frame: day 0 (transversal study)
Occurrence of mouth dryness
Time frame: day 0 (transversal study)
Occurrence of nasal dryness
Time frame: day 0 (transversal study)
Type/brand of mask and device used
Time frame: day 0 (transversal study)
Presence of heated humidifier
Time frame: day 0 (transversal study)
Presence of chinstraps.
Time frame: day 0 (transversal study)
The Brizzy output
Time frame: day 0 (transversal study)
Mask pressure as measured by Brizzy
Time frame: day 0 (transversal study)
Presence/absence of technical problems that arise in relation to the analysis of leaks
Time frame: day 0 (transversal study)
Presence/absence of a comorbidity
Time frame: day 0 (transversal study)
Presence of a psychotropic treatment
Time frame: day 0 (transversal study)
Presence of a treatment of nasal problem
Time frame: day 0 (transversal study)
Anterior ORL surgery
Time frame: day 0 (transversal study)
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Montpellier