Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06119087
The ClinicalTrials.gov registry entry for NCT06119087 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 898-participant average among 102 other Amyotrophic Lateral Sclerosis trials with a reported enrollment target (98% lower). The listed sponsor is University of Pennsylvania, which has 1,423 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
-
Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)
RECRUITING · NA
-
Assessing Perceptual Effects of Interactive Tasks
RECRUITING · NA
-
Spinal Cord Associative Plasticity for ALS
RECRUITING · NA
-
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
RECRUITING · NA
-
Oral Intake of Enteral Nutrition Formula Preceding Placement and Feeding Via GTube and Its Impact on Formula Intolerance in pALS
RECRUITING · NA
-
Precise Robotically IMplanted Brain-Computer InterfacE
RECRUITING · NA
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.