- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04729920
Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
January 31, 2021 updated by: GEORGIA MITROPOULOU, Centre Hospitalier Universitaire Vaudois
Predictors of Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Patients: a Cross-sectional Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
43
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1011
- Service de Pneumologie, CHUV
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
subjects with neuromuscular disease
Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months
|
download of device (MI-E) data and self-reported satisfaction with the device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to MI-E (reported)
Time Frame: 12 months, or since treatment initiation (> 3 months)
|
based on self-reported use
|
12 months, or since treatment initiation (> 3 months)
|
Adherence to MI-E (objective)
Time Frame: 12 months, or since treatment initiation (> 3 months)
|
based on data downloads
|
12 months, or since treatment initiation (> 3 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction with the device
Time Frame: 12 months, or since treatment initiation (> 3 months)
|
Self-report questionnaire
|
12 months, or since treatment initiation (> 3 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Actual)
May 1, 2020
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
January 25, 2021
First Submitted That Met QC Criteria
January 25, 2021
First Posted (Actual)
January 29, 2021
Study Record Updates
Last Update Posted (Actual)
February 3, 2021
Last Update Submitted That Met QC Criteria
January 31, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-01114
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neuromuscular Diseases
-
Brugmann University HospitalCompletedAnesthesia, General | Neuromuscular Transmission DisordersBelgium
-
University Hospital, ToursCompletedNeuromuscular Diseases in Children | Neuromuscular Diseases in InfantsFrance
-
Ottawa Hospital Research InstituteRecruiting
-
University of FloridaTerminated
-
Penwest Pharmaceuticals Co.TerminatedNeuromuscular DiseaseUnited Kingdom
-
National Institute of Nursing Research (NINR)TerminatedNeuromuscular DiseaseUnited States
-
Landon Pediatric FoundationCompleted
-
Institut de Myologie, FranceCompleted
-
Linde AGCompletedFunctional Test, COPD, Neuromuscular Disorders, Mechanical Ventilation, Weaning, DisabilityArgentina, Colombia, Germany
Clinical Trials on Mechanical insufflation/exsufflation device (MI-E)
-
University Hospital Inselspital, BerneRecruitingNeuromuscular Diseases in ChildrenSwitzerland
-
Assistance Publique - Hôpitaux de ParisTerminatedNeuromuscular Diseases | Amyotrophic Lateral Sclerosis | Duchenne Muscular DystrophyFrance
-
The Catholic University of KoreaCompletedStroke | DysphagiaKorea, Republic of
-
Hospital Sao JoaoCompletedVentilatory Failure | Post-extubation Failure | Persistent Weaning Failure | Secretion Encumbrance | Weak CoughPortugal
-
Academisch Medisch Centrum - Universiteit van Amsterdam...RecruitingCritically IllNetherlands
-
Odense University HospitalCompleted
-
University Hospital, BordeauxSociedad Española de Neumología y Cirugía TorácicaUnknownMechanical Ventilation Complication | Mucus Retention | Mucus; Plug, TracheobronchialFrance
-
Assiut UniversityNot yet recruitingMechanically Ventilated Patients
-
Hospital Moinhos de VentoUnknownRespiratory FailureBrazil
-
Universidade Federal de Sao CarlosPhilips Respironics; Hospital Estadual Américo BrasilienseUnknownPalliative Care | Mucus HypersecretionBrazil