Ineffective cough due to respiratory muscle weakness in neuromuscular diseases Reduced cough strength in people with neuromuscular diseases
Conditions
Interventions
The iStack is a hands-free device that delivers air into the lungs in a similar way to the manual resuscitation balloon, but without requiring hand strength. The device was developed by UMC Utrecht in
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Aged 18 years or older Diagnosed with amyotrophic lateral sclerosis (ALS) or other neuromuscular diseaseAirstacking has been prescribed by a rehabilitation or a home mechanical ventilation physicianPrior experience with air stackingImpaired hand function that may compromise the performance of manual air stacking, irrespective of whether the participant can still perform the technique independentlyExpected survival of more than one year, as assessed by the treating rehabilitation or home ventilation physicianAble to understand Dutch (all study materials and device instructions are in Dutch)Has provided written informed consent
Exclusion criteria
Exclusion criteria: Severe bulbar dysfunction that prevents safe or tolerable use of air stacking.Severe cognitive impairments or diagnosed with frontotemporal dementia preventing understanding of informed consent or adherence to study instructions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We will assess whether using the iStack is feasible for patients. This will be evaluated in three ways:Adherence How often was the iStack used over the 10 weeks? This will be compared to the baseline use of the manual resuscitation balloon.Patient preference After 10 weeks iStack usage, participants will indicate which device they prefer: the iStack or the manual balloon. We will look at the percentage of participants who favor the iStack. | — |
Secondary
| Measure | Time frame |
|---|---|
| In addition to the main goal, we will also look at:How well the device works to help with coughing, based on what patients tell us.Suggestions for improvement, collected through a short questionnaire and feedback from participants.How strong the cough is when using iStack compared to the hand balloon. This is measured with a simple test called Peak Cough Flow, which shows fast air is pushed out during a cough. | — |
Countries
Netherlands
Contacts
Public ContactJ.A.J.M. Beelen
Universitair Medisch Centrum Utrecht
Outcome results
None listed