NCT06119087Completed
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn. Based on prior research, we believe that 6-months of MI may slow decline in cough strength, measured as peak cough flow (PCF). Participants will perform MI using a device designed for mechanical insufflation-exsufflation (MI-E) known as the BiWaze Cough system. The BiWaze Cough is used for mucus clearance . It is connected to tubing and mouthpiece (or mask). The device will use programmed pressure and timing settings. An insufflation includes inflating the lungs for a maximal size inhalation before exhaling. The daily routine for the device includes 5 sets of 5 insufflations twice daily. Researchers will compare how use of MI in early ALS affects peak cough flow compared to 20 subjects who did not use MI in early ALS.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 31 Oct 2023
- Start date
- 12 Sept 2024
- Primary completion date
- 30 Jul 2026
- Lead sponsor
- University of Pennsylvania
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06119087
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 12 Sept 2024 to the primary completion date, 30 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Current use of MI-E (also known as a "cough assist device") for airway clearance. Please note that patients can start use of a MI-E device subsequent to enrollment while currently being followed for the study.
- Medical history of any of the following:
- Recent hemoptysis
- Recent barotrauma
- History of emphysema of any kind (including bullous emphysema)
- History of or known susceptibility to pneumothorax
- History of or known susceptibility to pneumomediastinum
- Chronic obstructive pulmonary disease
- Uncontrolled asthma (defined as recent exacerbation requiring corticosteroids in the previous 30 days)
- Symptomatic cardiomyopathy (heart failure) with left ventricular ejection fraction less than 50%
- History of right heart failure or pulmonary hypertension
Age
- Age \<18 years old.
Other
- Inability to perform a cough peak flow or spirometry manuever
- Current use of non-invasive ventilation (NIV), bi-level positive pressure ventilation, or "Bi-PAP" or physician prescribing NIV on day of potential enrollment.
- Active enrollment in hospice.
- Current tracheostomy.
- Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician.
- Absence of an able and willing caregiver to assist with MI twice daily as specified in the protocol.
- Pregnancy
- Current smoker or tobacco use within the last 30 days.
Who the study is looking for
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years.
- Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria.
- Have an able and willing caregiver to assist with mechanical insufflation on a daily basis.
- Willingness and ability to participate in study procedures.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.