Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119087
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-10-31
Brief Title:
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort MI-PALS Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort MI-PALS Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MI-PALS
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 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None