Obstructive Sleep Apnea SyndromeSAS-leak-1NCT03381508
Air Leakage Under Continuous Positive Airway Pressure
An observational study of Obstructive Sleep Apnea Syndrome, run by University Hospital, Montpellier at 3 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Brizzy continuous positive pressure device
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Jan 2018to 20 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Polyclinic Saint-Privat
Boujan-sur-Libron, 34760
University Hospital of Grenoble
Grenoble
Hôpital Arnaud de Villeneuve
Montpellier
About this study
Official title: Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With 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.
Read more
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
Read the detailed description
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.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Brizzy continuous positive pressure device
- Keywords
- CPAP, masks, unintentional leak, leakage
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brizzy continuous positive pressure deviceDevice
Patients are treated with the Brizzy continuous positive pressure device, including pneumotachograph.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Brizzy continuous positive pressure device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth-opening odds ratio
For each patient presenting with an unintentional leak, determination of odds ratios for mouth-opening.
Measured: 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
Measured: day 0 (transversal study)
Sleep position odds ratio
For each patient presenting with an unintentional leak, determination of odds ratios for sleep position
Measured: 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
Measured: day 0 (transversal study)
Secondary outcomes (5)
Epworth scale score
Measured: day 0 (transversal study)
Pichot scale
Measured: day 0 (transversal study)
Occurrence of nasal obstruction
Measured: day 0 (transversal study)
Occurrence of mouth dryness
Measured: day 0 (transversal study)
Occurrence of nasal dryness
Measured: day 0 (transversal study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start10 Jan 2018
- Primary completion20 Apr 2018
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christian Borel, PhD, Principal investigator, University Hospital, GrenobleNicolas Molinari, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03381508
- Sponsor's protocol ID
- RECHMPL17_0429
- Acronym
- SAS-leak-1
- Status last verified
- Jun 2020
- First submitted
- 18 Dec 2017
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28847549Lebret 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.
PubMed 32544491
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Determinants of Air Leakage in a Population of Obstructive Sleep Apnea Syndrome Treated With Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT03381508
- Acronym / sponsor ID
- SAS-leak-1 / RECHMPL17_0429
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- CPAP, masks, unintentional leak, leakage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 20 Apr 2018 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 22 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Device: Brizzy continuous positive pressure deviceThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brizzy continuous positive pressure devicePatients are treated with the Brizzy continuous positive pressure device, including pneumotachograph. | Device | The study population |
Primary outcome
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.
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
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
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
5 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Results publication: PubMed 28847549Lebret 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.
- Results publication: PubMed 32544491Lebret 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Christian Borel, PhD principal investigator
University Hospital, Grenoble
Nicolas Molinari, PhD study director
University Hospital, Montpellier
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome, run by University Hospital, Montpellier at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mouth-opening odds ratio (time frame: day 0 (transversal study)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03381508, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.