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NCT04729920 Clinical Trial

Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases

Neuromuscular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04729920
Other study ID # 2019-01114
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2019
Est. completion date May 1, 2020

Study information
Verified date January 2021
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 43
Est. completion date May 1, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age over 18 years - Diagnosis of neuromuscular disease - Active prescription of MI-E for more than 3 months Exclusion Criteria: -Invasive airway

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Mechanical insufflation/exsufflation device (MI-E)
download of device (MI-E) data and self-reported satisfaction with the device

Locations
Country Name City State
Switzerland Service de Pneumologie, CHUV Lausanne Vaud

Sponsors (3)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois Ligue Pulmonaire Vaudoise, University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adherence to MI-E (reported) based on self-reported use 12 months, or since treatment initiation (> 3 months)
Primary Adherence to MI-E (objective) based on data downloads 12 months, or since treatment initiation (> 3 months)
Secondary Satisfaction with the device Self-report questionnaire 12 months, or since treatment initiation (> 3 months)
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