CPAP and NIV Interfaces : Side-effects in Home Care Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-07

Study Completion Date

2019-04-01

Brief Summary

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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.

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Detailed Description

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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

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Interface, Mask Continuous Positive Airway Pressure (CPAP) Non Invasive Ventilation (NIV) Hyperventilation Anxiety Sleep Apnea Syndrome (OSAS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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self questionnaire

* Interface side effects and degree of satisfaction of the patients
* Technician evaluation and device measures.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No