Neuromuscular DiseasesNCT04729920
Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Diseases
An observational study of Neuromuscular Diseases, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Mechanical insufflation/exsufflation device (MI-E)
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Sep 2019to 1 May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months
Who may be able to join
- Age over 18 years
- Diagnosis of neuromuscular disease
- Active prescription of MI-E for more than 3 months
Who cannot join
- -Invasive airway
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Service de Pneumologie, CHUV
Lausanne, Canton of Vaud, 1011
About this study
Official title: 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.
- Conditions
- Neuromuscular Diseases
- Being tested
- Mechanical insufflation/exsufflation device (MI-E)
- Keywords
- Mechanical insufflation-exsufflation, Cough assistance
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical insufflation/exsufflation device (MI-E)Device
download of device (MI-E) data and self-reported satisfaction with the device
| Study group | Role | What they receive |
|---|---|---|
| subjects with neuromuscular disease | Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months Receives: Device: Mechanical insufflation/exsufflation device (MI-E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to MI-E (reported)
based on self-reported use
Measured: 12 months, or since treatment initiation (> 3 months)
Adherence to MI-E (objective)
based on data downloads
Measured: 12 months, or since treatment initiation (> 3 months)
Secondary outcomes (1)
Satisfaction with the device
Self-report questionnaire
Measured: 12 months, or since treatment initiation (> 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2021
- Study start15 Sep 2019
- Primary completion1 May 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- Ligue Pulmonaire Vaudoise, University Hospital, Geneva
- Responsible party
- Principal investigator, GEORGIA MITROPOULOU, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04729920
- Sponsor's protocol ID
- 2019-01114
- Other IDs
- 2019
- Status last verified
- Jan 2021
- First submitted
- 25 Jan 2021
- Last updated
- 3 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Home Use of Mechanical Insufflation/Exsufflation Devices in Neuromuscular Patients: a Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04729920
- Acronym / sponsor ID
- 2019-01114
- Conditions
- Neuromuscular Diseases
- Keywords
- Mechanical insufflation-exsufflation, Cough assistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- Ligue Pulmonaire Vaudoise, University Hospital, Geneva
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 29 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with neuromuscular disease | – | Device: Mechanical insufflation/exsufflation device (MI-E)Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects with neuromuscular disease, with an active prescription of MI-E for more than 3 months
Key inclusion criteria (3 listed)
- Age over 18 years
- Diagnosis of neuromuscular disease
- Active prescription of MI-E for more than 3 months
Key exclusion criteria (1 listed)
- -Invasive airway
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mechanical insufflation/exsufflation device (MI-E)download of device (MI-E) data and self-reported satisfaction with the device | Device | subjects with neuromuscular disease |
Primary outcome
Adherence to MI-E (reported)
Time frame: 12 months, or since treatment initiation (> 3 months)
based on self-reported use
Adherence to MI-E (objective)
Time frame: 12 months, or since treatment initiation (> 3 months)
based on data downloads
1 secondary outcome
Satisfaction with the device
Time frame: 12 months, or since treatment initiation (> 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
Related trials for Neuromuscular Diseases
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Active, not recruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromuscular Diseases, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence to MI-E (reported) (time frame: 12 months, or since treatment initiation (> 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.