Clinical trial NCT03013283: CPAP and NIV Interfaces : Side-effects in Home Care Patients
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interface, Mask
Continuous Positive Airway Pressure (CPAP)
Non Invasive Ventilation (NIV)
Hyperventilation Anxiety
Sleep Apnea Syndrome (OSAS)
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-01-06
Enrollment: 6000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Interface side effects and degree of satisfaction of the patients
timeFrame: 1 day
Secondary outcomes:
measure: Identification by the technician of the problems of pain
timeFrame: 1 day
measure: Percentage of patients with oxygen therapy, heated humidifier, chinstrap.
timeFrame: 1 day
measure: Collection by technician of the type of interface
timeFrame: 1 day
measure: Compliance
timeFrame: 1 day
measure: Average level of intentional or unintentional leakage
timeFrame: 1 day
measure: Residual AHI
timeFrame: 1 day
measure: Average pressure level and pressure
timeFrame: 1 day
measure: Patient quality of life questionnaire
timeFrame: 1 day
measure: Date of first installation of the first ventilation device
timeFrame: 1 day
measure: Proportion of patient responding to self-help questionnaire without assistance
timeFrame: 1 day
measure: Proportion of patients able to position the interface without assistance
timeFrame: 1 day
measure: Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.
timeFrame: 1 day
measure: Proportion of patient waiting for a new interface
timeFrame: 1 day
measure: Proportion of patients wishing to participate in research on the subject.
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: University Hospital, Montpellier
name: Dany JAFFUEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rotty 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.