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NCT06119087 · ClinicalTrials.gov registry record · NA
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
A NA study of Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, sponsored by University of Pennsylvania.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06119087: Recruiting NA study of Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, sponsored by University of Pennsylvania.
NCT06119087 is a NA study of Amyotrophic Lateral Sclerosis and Neuromuscular Diseases that is actively recruiting participants, run by University of Pennsylvania. The registered enrollment target is 20 participants, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06119087, a NA study of Amyotrophic Lateral Sclerosis and Neuromuscular Diseases, is actively recruiting participants, sponsored by University of Pennsylvania.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
PCF in liters/minute as measured by use of a peak flow meter while the patient is in a seated upright position. An alternative device for measuring PCF can be the use of a handheld spirometer and using the measured peak expiratory flow by multiplying by 60 to convert from liters/second to liters/minute. The subject must be seated in an upright position and the interface must include a mouthpiece or an oronasal mask. Subjects are asked to perform a deep inhalation followed by a maximal cough.
Conditions Studied
Interventions
- DEVICE Mechanical insufflation
Study Locations (1)
Pennsylvania
- University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-12 |
| Est. Completion | 2026-06-08 |
| Phase | NA |
What NCT06119087 shows while recruiting
NCT06119087 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower).
The record links to 4 conditions, with Amyotrophic Lateral Sclerosis appearing as the primary indexed condition, and to 1 intervention - of which Mechanical insufflation is the first listed.
NCT06119087 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06119087 about?
NCT06119087 is a clinical study titled "Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study". 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 ...
What is the current status of trial NCT06119087?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2024-09-12. Estimated completion is 2026-06-08.
What conditions does trial NCT06119087 study?
This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis, Neuromuscular Diseases, Airway Clearance Impairment, Chronic Respiratory Failure.
What interventions are being tested in trial NCT06119087?
The interventions under investigation include: Mechanical insufflation (DEVICE).
Who is sponsoring clinical trial NCT06119087?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06119087 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06119087's enrollment target sits among peer trials
20 78th of 102 higher than 23 of 102 other Amyotrophic Lateral Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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