Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases

• Sponsor: Centre Hospitalier Universitaire Vaudois (Other)
• Overall Status: Completed
• CT.gov ID: NCT04729920
• Collaborator: Ligue Pulmonaire Vaudoise (Other), University Hospital, Geneva (Other)
• Enrollment: 43
• Location: 1
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Neuromuscular Diseases	Device: Mechanical insufflation/exsufflation device (MI-E)

Study Design

• Study Type: Observational
• Actual Enrollment: 43 participants
• Observational Model: Case-Only
• Time Perspective: Cross-Sectional
• Official Title: Predictors of Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Patients: a Cross-sectional Study
• Actual Study Start Date: Sep 15, 2019
• Actual Primary Completion Date: May 1, 2020
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
subjects with neuromuscular disease Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months	Device: Mechanical insufflation/exsufflation device (MI-E); download of device (MI-E) data and self-reported satisfaction with the device

Outcome Measures

Primary Outcome Measures

1. Adherence to MI-E (reported) [12 months, or since treatment initiation (> 3 months)]

   based on self-reported use

2. Adherence to MI-E (objective) [12 months, or since treatment initiation (> 3 months)]

   based on data downloads

Secondary Outcome Measures

1. Satisfaction with the device [12 months, or since treatment initiation (> 3 months)]

   Self-report questionnaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age over 18 years

• Diagnosis of neuromuscular disease

• Active prescription of MI-E for more than 3 months

Exclusion Criteria:

-Invasive airway

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Service de Pneumologie, CHUV	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• Centre Hospitalier Universitaire Vaudois
• Ligue Pulmonaire Vaudoise
• University Hospital, Geneva

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GEORGIA MITROPOULOU, Cheffe de clinique, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT04729920
• Other Study ID Numbers: 2019-01114
• First Posted: Jan 29, 2021
• Last Update Posted: Feb 3, 2021
• Last Verified: Jan 1, 2021

• 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
• Keywords provided by GEORGIA MITROPOULOU, Cheffe de clinique, Centre Hospitalier Universitaire Vaudois: Mechanical insufflation-exsufflation; Cough assistance
• Additional relevant MeSH terms: Neuromuscular Diseases

Study Results

No Results Posted as of Feb 3, 2021