Interface, MaskInterfaceVentNCT03013283
CPAP and NIV Interfaces : Side-effects in Home Care Patients
An observational study of Interface, Mask and Continuous Positive Airway Pressure (CPAP), run by University Hospital, Montpellier at 2 sites in France.
Trial summary
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interface, Mask, Continuous Positive Airway Pressure (CPAP), Non Invasive Ventilation (NIV)
- What is being tested?
- self questionnaire
- How many people
- 6,000 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Feb 2017to 1 Apr 2019
- 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 patients included in the study corresponded to the annual cohort of patients cared by the APARD home care provider. Patients are were treated with CPAP or VIN for more than 3 months according to the criteria of care and reimbursement of the French Social Security rules.
Who may be able to join
- Written informed consent
- Age more than 18 years (inclusive)
- Patient treated with CPAP or NIV for at least three months,and eligible for care and for the reimbursement by the French Social Security rules.
- Patient presents during a scheduled home visit of the technician for the continuation of CPAP or NIV treatment according to the French Social Security rules.
Who cannot join
- Pregnancy, intention of being pregnant, breastfeeding.
- Inability to understand the nature and aims of the study or to communicate with the investigator
- Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
- No affiliation to the French social security
- Loss of personal capacity resulting in state protection
- Deprivation of liberty by judicial or administrative decision
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Official title: Descriptional Study of the Side Effects Related to the Use of the Interface in Home Care Patients Treated for at Least 3 Months by Continuous Positive Pressure or Non-Invasive Ventilation.
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface.
The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.
The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV.
Read the detailed description
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP (the level of pressure delivered being constant) and Non Invasive Ventilation or NIV (pressure level varies from an expiratory pressure to an inspiratory pressure). Whether for CPAP or NIV, pressures are delivered to the patient via an interface. Many manufacturers produce interfaces and these interfaces are the subject of regular technological innovations with the introduction on the market of new product ranges.
Because of the lack of dedicated and actualized studies, there is poor evidence based of difference between old and new interfaces, there is also poor evidence based of differences between manufacturer products.
The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.
The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV. A visual analog scale is used to assess the patient perception of its interface. A measure of the quality of life and a home care technician evaluation are performed simultaneously. Using the device manufacturer software, a measure of the observance, level of pressure and leak is realised.
A first intermediate analysis will be made after approximately 1000 inclusions (the Sleepileaks (determinants of residual excessive sleapiness), Threshleaks (high leak levels and machine adherence as defined by the American Thoracic Society) and Complileaks studies (all leaks and machine adherence as continuous variables)). A second validating analysis will be made at the end of inclusions.
- Conditions
- Interface, Mask, Continuous Positive Airway Pressure (CPAP), Non Invasive Ventilation (NIV), Hyperventilation Anxiety, Sleep Apnea Syndrome (OSAS)
- Being tested
- self questionnaire
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self questionnaireOther
- Interface side effects and degree of satisfaction of the patients
- Technician evaluation and device measures.
What is being measured
The primary outcome is the main question the study is designed to answer.
Interface side effects and degree of satisfaction of the patients
During a scheduled home visit of the technician. The primary endpoint is a composite criterion corresponding to the patients' responses to a self-administered questionnaire.
Measured: 1 day
Secondary outcomes (14)
Identification by the technician of the problems of pain
During a scheduled home visit of the technician : Identification by the technician of the problems of pain, erythema and leak, localization of these problems.
Measured: 1 day
Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
During a scheduled home visit of the technician : Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
Measured: 1 day
Collection by technician of the type of interface
During a scheduled home visit of the technician : Collection by technician of the type of interface (nasal pillows, nasal and oronasal, custom made interface), manufacturer name and interface size, type (CPAP/NIV) and manufacturer name of the device.
Measured: 1 day
Compliance
During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months
Measured: 1 day
Average level of intentional or unintentional leakage
During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)
Measured: 1 day
Residual AHI
During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)
Measured: 1 day
Average pressure level and pressure
During a scheduled home visit of the technician :Device software data: average pressure level and pressure at the 90/95th percentile (cmH2O).
Measured: 1 day
Patient quality of life questionnaire
Patient quality of life questionnaire (EQ-5D 3L, Epworth).
Measured: 1 day
Date of first installation of the first ventilation device
Date of first installation of the first ventilation device
Measured: 1 day
Proportion of patient responding to self-help questionnaire without assistance
Proportion of patient responding to self-help questionnaire without assistance
Measured: 1 day
Proportion of patients able to position the interface without assistance
Proportion of patients able to position the interface without assistance
Measured: 1 day
Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
Measured: 1 day
Proportion of patient waiting for a new interface
Proportion of patient waiting for a new interface
Measured: 1 day
Proportion of patients wishing to participate in research on the subject.
Proportion of patients wishing to participate in research on the subject.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start7 Feb 2017
- Primary completion1 Apr 2019
- Study completion1 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Interface, MaskStudies 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
- Prospective
- Enrolment
- 6,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dany JAFFUEL, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013283
- Sponsor's protocol ID
- RECHMPL16_0337
- Acronym
- InterfaceVent
- Status last verified
- Apr 2019
- First submitted
- 23 Dec 2016
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.
PubMed 31514751Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.
PubMed 33451313Vidal C, Mallet JP, Skinner S, Gilson R, Gaubert O, Prigent A, Gagnadoux F, Borel JC, Bourdin A, Molinari N, Jaffuel D. Positive Airway Pressure-Related Aerophagia in Obstructive Sleep Apnea: Results from the InterfaceVent Real-Life Study. J Clin Med. 2025 Sep 11;14(18):6424. doi: 10.3390/jcm14186424.
PubMed 41010628Vidal C, Bertelli F, Mallet JP, Gilson R, Borel JC, Gagnadoux F, Skinner S, Bourdin A, Molinari N, Jaffuel D. Added value of technician intervention to improve mask management for apneic patients treated with long-term CPAP. Sleep Breath. 2025 Feb 28;29(1):117. doi: 10.1007/s11325-025-03279-2.
PubMed 40019603Vidal C, Bertelli F, Mallet JP, Gilson R, Borel JC, Gagnadoux F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study. Respir Res. 2024 Sep 6;25(1):331. doi: 10.1186/s12931-024-02965-1.
PubMed 39243031
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Descriptional Study of the Side Effects Related to the Use of the Interface in Home Care Patients Treated for at Least 3 Months by Continuous Positive Pressure or Non-Invasive Ventilation.
- ClinicalTrials.gov ID
- NCT03013283
- Acronym / sponsor ID
- InterfaceVent / RECHMPL16_0337
- Conditions
- Interface, Mask, Continuous Positive Airway Pressure (CPAP), Non Invasive Ventilation (NIV), Hyperventilation Anxiety, Sleep Apnea Syndrome (OSAS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2019 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP and Non Invasive Ventilation or NIV. Whether for CPAP or NIV, pressures are delivered to the patient via an interface.
The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.
The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV.
Detailed description
Home ventilation techniques consist mainly of two techniques, Continuous Positive Airway Pressure or CPAP (the level of pressure delivered being constant) and Non Invasive Ventilation or NIV (pressure level varies from an expiratory pressure to an inspiratory pressure). Whether for CPAP or NIV, pressures are delivered to the patient via an interface. Many manufacturers produce interfaces and these interfaces are the subject of regular technological innovations with the introduction on the market of new product ranges.
Because of the lack of dedicated and actualized studies, there is poor evidence based of difference between old and new interfaces, there is also poor evidence based of differences between manufacturer products.
The efficacy of CPAP and NIV is conditioned in part by the observance of the patients to the device. Because the comfort and degree of satisfaction of the patients to its interface is a key factor of the observance, side-effects and satisfaction of patients need to be continuously evaluated with available interfaces for CPAP and NIV treated patients.
The purpose of the research is the evaluation of interface side-effects and the degree of satisfaction of home care patients treated for at least three months with CPAP or NIV. A visual analog scale is used to assess the patient perception of its interface. A measure of the quality of life and a home care technician evaluation are performed simultaneously. Using the device manufacturer software, a measure of the observance, level of pressure and leak is realised.
A first intermediate analysis will be made after approximately 1000 inclusions (the Sleepileaks (determinants of residual excessive sleapiness), Threshleaks (high leak levels and machine adherence as defined by the American Thoracic Society) and Complileaks studies (all leaks and machine adherence as continuous variables)). A second validating analysis will be made at the end of inclusions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients included in the study corresponded to the annual cohort of patients cared by the APARD home care provider. Patients are were treated with CPAP or VIN for more than 3 months according to the criteria of care and reimbursement of the French Social Security rules.
Key inclusion criteria (4 listed)
- Written informed consent
- Age more than 18 years (inclusive)
- Patient treated with CPAP or NIV for at least three months,and eligible for care and for the reimbursement by the French Social Security rules.
- Patient presents during a scheduled home visit of the technician for the continuation of CPAP or NIV treatment according to the French Social Security rules.
Key exclusion criteria (6 listed)
- Pregnancy, intention of being pregnant, breastfeeding.
- Inability to understand the nature and aims of the study or to communicate with the investigator
- Simultaneous participation in another trial with an exclusion clause to participate to an other trial.
- No affiliation to the French social security
- Loss of personal capacity resulting in state protection
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 |
|---|---|---|
| self questionnaire* Interface side effects and degree of satisfaction of the patients * Technician evaluation and device measures. | Other | – |
Primary outcome
Interface side effects and degree of satisfaction of the patients
Time frame: 1 day
During a scheduled home visit of the technician. The primary endpoint is a composite criterion corresponding to the patients' responses to a self-administered questionnaire.
14 secondary outcomes
Identification by the technician of the problems of pain
Time frame: 1 day
Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
Time frame: 1 day
Collection by technician of the type of interface
Time frame: 1 day
Compliance
Time frame: 1 day
Average level of intentional or unintentional leakage
Time frame: 1 day
Residual AHI
Time frame: 1 day
Average pressure level and pressure
Time frame: 1 day
Patient quality of life questionnaire
Time frame: 1 day
Date of first installation of the first ventilation device
Time frame: 1 day
Proportion of patient responding to self-help questionnaire without assistance
Time frame: 1 day
Proportion of patients able to position the interface without assistance
Time frame: 1 day
Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
Time frame: 1 day
Proportion of patient waiting for a new interface
Time frame: 1 day
Proportion of patients wishing to participate in research on the subject.
Time frame: 1 day
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 27 Jan 2021.
- Results publication: PubMed 31514751Rotty MC, Mallet JP, Suehs CM, Martinez C, Borel JC, Rabec C, Bourdin A, Molinari N, Jaffuel D. Is the 2013 American Thoracic Society CPAP-tracking system algorithm useful for managing non-adherence in long-term CPAP-treated patients? Respir Res. 2019 Sep 12;20(1):209. doi: 10.1186/s12931-019-1150-7.
- Results publication: PubMed 33451313Rotty MC, Suehs CM, Mallet JP, Martinez C, Borel JC, Rabec C, Bertelli F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects in long-term CPAP-patients impact adherence and sleepiness: the InterfaceVent real-life study. Respir Res. 2021 Jan 15;22(1):17. doi: 10.1186/s12931-021-01618-x.
- Derived from this study: PubMed 41010628Vidal C, Mallet JP, Skinner S, Gilson R, Gaubert O, Prigent A, Gagnadoux F, Borel JC, Bourdin A, Molinari N, Jaffuel D. Positive Airway Pressure-Related Aerophagia in Obstructive Sleep Apnea: Results from the InterfaceVent Real-Life Study. J Clin Med. 2025 Sep 11;14(18):6424. doi: 10.3390/jcm14186424.
- Derived from this study: PubMed 40019603Vidal C, Bertelli F, Mallet JP, Gilson R, Borel JC, Gagnadoux F, Skinner S, Bourdin A, Molinari N, Jaffuel D. Added value of technician intervention to improve mask management for apneic patients treated with long-term CPAP. Sleep Breath. 2025 Feb 28;29(1):117. doi: 10.1007/s11325-025-03279-2.
- Derived from this study: PubMed 39243031Vidal C, Bertelli F, Mallet JP, Gilson R, Borel JC, Gagnadoux F, Bourdin A, Molinari N, Jaffuel D. Mask side-effects are related to gender in long-term CPAP: results from the InterfaceVent real-life study. Respir Res. 2024 Sep 6;25(1):331. doi: 10.1186/s12931-024-02965-1.
- InterfaceVent on the Open Science FrameworkLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Interface, Mask
Recruiting
Supraglottic Airway for Resuscitation in Preemies
Respiratory Failure, Premature Neonates
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.
Dany JAFFUEL, MD, PhD principal investigator
University Hospital, Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interface, Mask and Continuous Positive Airway Pressure (CPAP), run by University Hospital, Montpellier at 2 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 4 inclusion and 6 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 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Interface side effects and degree of satisfaction of the patients (time frame: 1 day). 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 NCT03013283, which also lists 5 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 27 Jan 2021.