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

NCT03013283 | Completed

• 1 other identifier: RECHMPL16_0337
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day

Secondary Outcomes (14)

• Identification by the technician of the problems of pain

  1 day

• Percentage of patients with oxygen therapy, heated humidifier, chinstrap.

  1 day

• Collection by technician of the type of interface

  1 day

• Compliance

  1 day

• Average level of intentional or unintentional leakage

  1 day

Interventions

self questionnaire OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy, intention of being pregnant, breastfeeding.
• Inability to understand the nature and aims of the study or to communicate with the investigator
• No affiliation to the French social security
• Loss of personal capacity resulting in state protection
• Deprivation of liberty by judicial or administrative decision

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

CHU Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (5)

• 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.

  PMID: 31514751 RESULT

• 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.

  PMID: 33451313 RESULT

• Vidal 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.

  PMID: 41010628 DERIVED

• Vidal 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.

  PMID: 40019603 DERIVED

• Vidal 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.

  PMID: 39243031 DERIVED

Related Links

• InterfaceVent on the Open Science Framework

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Dany JAFFUEL, MD, PhD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2016
• First Posted: January 6, 2017
• Study Start: February 7, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: January 27, 2021

Record last verified: 2019-04

Locations

FR (2)