Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study (NCT06119087) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
United States20 participantsStarted 2024-09-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. Age \<18 years old.
✕. 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.
✕. 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.