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Completed

NCT Number: NCT04729920

Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases

With this cross-sectional study of adult subjects with neuromuscular disease in the French-speaking part of Switzerland, we aim to explore MI-E adherence using self-report questionnaires and device data in order to identify the factors that influence the pattern of MI-E use and satisfaction with the treatment. Determining potential barriers to regular long-term home use of MI-E could help in identifying the patients who would benefit most from this therapy.

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Key information

Conditions

Neuromuscular Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Pneumologie, CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years
  • Diagnosis of neuromuscular disease
  • Active prescription of MI-E for more than 3 months

Exclusion criteria

-Invasive airway

Treatment and study plan

Mechanical insufflation/exsufflation device (MI-E)

Device

download of device (MI-E) data and self-reported satisfaction with the device

Primary outcomes

  1. Adherence to MI-E (reported)

    Time frame: 12 months, or since treatment initiation (> 3 months)

    based on self-reported use

  2. Adherence to MI-E (objective)

    Time frame: 12 months, or since treatment initiation (> 3 months)

    based on data downloads

Secondary outcomes

  1. Satisfaction with the device

    Time frame: 12 months, or since treatment initiation (> 3 months)

    Self-report questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Collaborators

  • Ligue Pulmonaire Vaudoise
  • University Hospital, Geneva

Registry information

Official study title

Predictors of Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Patients: a Cross-sectional Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 29, 2021
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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