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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03013283
Recruitment Status : Completed
First Posted : January 6, 2017
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Study Description
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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.


Condition or disease Intervention/treatment
Interface, Mask Continuous Positive Airway Pressure (CPAP) Non Invasive Ventilation (NIV) Hyperventilation Anxiety Sleep Apnea Syndrome (OSAS) Other: self questionnaire

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
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Study Type : Observational
Actual Enrollment : 6000 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Actual Study Start Date : February 7, 2017
Actual Primary Completion Date : April 1, 2019
Actual Study Completion Date : April 1, 2019
Groups and Cohorts
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Intervention Details:
  • Other: self questionnaire
    • Interface side effects and degree of satisfaction of the patients
    • Technician evaluation and device measures.

Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Identification by the technician of the problems of pain [ Time Frame: 1 day ]
    During a scheduled home visit of the technician : Identification by the technician of the problems of pain, erythema and leak, localization of these problems.

  2. Percentage of patients with oxygen therapy, heated humidifier, chinstrap. [ Time Frame: 1 day ]
    During a scheduled home visit of the technician : Percentage of patients with oxygen therapy, heated humidifier, chinstrap.

  3. Collection by technician of the type of interface [ Time Frame: 1 day ]
    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.

  4. Compliance [ Time Frame: 1 day ]
    During a scheduled home visit of the technician : Device software data: compliance (hour per day) over the last 3 months

  5. Average level of intentional or unintentional leakage [ Time Frame: 1 day ]
    During a scheduled home visit of the technician : Device software data: average level of intentional or unintentional leakage (l/min)

  6. Residual AHI [ Time Frame: 1 day ]
    During a scheduled home visit of the technician : Device software data: residual AHI (event/hour)

  7. Average pressure level and pressure [ Time Frame: 1 day ]
    During a scheduled home visit of the technician :Device software data: average pressure level and pressure at the 90/95th percentile (cmH2O).

  8. Patient quality of life questionnaire [ Time Frame: 1 day ]
    Patient quality of life questionnaire (EQ-5D 3L, Epworth).

  9. Date of first installation of the first ventilation device [ Time Frame: 1 day ]
    Date of first installation of the first ventilation device

  10. Proportion of patient responding to self-help questionnaire without assistance [ Time Frame: 1 day ]
    Proportion of patient responding to self-help questionnaire without assistance

  11. Proportion of patients able to position the interface without assistance [ Time Frame: 1 day ]
    Proportion of patients able to position the interface without assistance

  12. Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively. [ Time Frame: 1 day ]
    Time taken by the patient and the technician to answer the patient's self-questionnaire and the technician record respectively.

  13. Proportion of patient waiting for a new interface [ Time Frame: 1 day ]
    Proportion of patient waiting for a new interface

  14. Proportion of patients wishing to participate in research on the subject. [ Time Frame: 1 day ]
    Proportion of patients wishing to participate in research on the subject.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03013283


Locations
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France
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
CHU Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Dany JAFFUEL, MD, PhD University Hospital, Montpellier
More Information
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Additional Information:

Publications of Results:

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03013283    
Other Study ID Numbers: RECHMPL16_0337
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Hyperventilation
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Signs and Symptoms, Respiratory