Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
NCT ID: NCT06119087
Last Updated: 2025-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-09-12
2026-06-08
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Mechanical insufflation
Participants will be asked to perform mechanical insufflation using the BiWaze cough device as 5 sets of 5 insufflations twice daily for 6 months.
Mechanical insufflation
Mechanical insufflation (MI) is a chest physiotherapy exercise that will be performed using a type of mechanical insufflator-exsufflator (MI-E) known as the BiWaze Cough device. The device connects to a tube that can interface with a patient using either a facemask or mouthpiece.
Mechanical insufflation is a chest physiotherapy exercise that passively inflates the chest with positive pressure that is delivered in coordination with the patient's own inspiratory timing until maximal inflation capacity (MIC), determined by the patient or maximal chest rise on visual inspection. At MIC, the patient passively exhales, which completes one "cycle". Prior literature has used a "dose" of 5 sets of 5 cycles once or twice daily. The maneuver is usually performed with assistance of a caregiver to hold the mask or mouthpiece in place.
Interventions
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Mechanical insufflation
Mechanical insufflation (MI) is a chest physiotherapy exercise that will be performed using a type of mechanical insufflator-exsufflator (MI-E) known as the BiWaze Cough device. The device connects to a tube that can interface with a patient using either a facemask or mouthpiece.
Mechanical insufflation is a chest physiotherapy exercise that passively inflates the chest with positive pressure that is delivered in coordination with the patient's own inspiratory timing until maximal inflation capacity (MIC), determined by the patient or maximal chest rise on visual inspection. At MIC, the patient passively exhales, which completes one "cycle". Prior literature has used a "dose" of 5 sets of 5 cycles once or twice daily. The maneuver is usually performed with assistance of a caregiver to hold the mask or mouthpiece in place.
Eligibility Criteria
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Inclusion Criteria
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Age ≥18 years.
4. Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria.
5. Have an able and willing caregiver to assist with mechanical insufflation on a daily basis.
6. Willingness and ability to participate in study procedures.
Exclusion Criteria
2. Inability to perform a cough peak flow or spirometry manuever
3. Current use of non-invasive ventilation (NIV), bi-level positive pressure ventilation, or "Bi-PAP" or physician prescribing NIV on day of potential enrollment.
4. 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.
5. Active enrollment in hospice.
6. Current tracheostomy.
7. Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician.
8. Absence of an able and willing caregiver to assist with MI twice daily as specified in the protocol.
9. Pregnancy
10. Medical history of any of the following:
1. Recent hemoptysis
2. Recent barotrauma
3. History of emphysema of any kind (including bullous emphysema)
4. History of or known susceptibility to pneumothorax
5. History of or known susceptibility to pneumomediastinum
6. Chronic obstructive pulmonary disease
7. Uncontrolled asthma (defined as recent exacerbation requiring corticosteroids in the previous 30 days)
8. Symptomatic cardiomyopathy (heart failure) with left ventricular ejection fraction less than 50%
9. History of right heart failure or pulmonary hypertension
11. Current smoker or tobacco use within the last 30 days.
18 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Responsible Party
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Principal Investigators
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Jason Ackrivo, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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854981
Identifier Type: -
Identifier Source: org_study_id
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