Status:
RECRUITING
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
Lead Sponsor:
University of Pennsylvania
Conditions:
Amyotrophic Lateral Sclerosis
Chronic Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 (AL...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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
- 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
- Current smoker or tobacco use within the last 30 days.
Key Trial Info
Start Date :
September 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 8 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06119087
Start Date
September 12 2024
End Date
June 8 2026
Last Update
October 21 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104