Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-01 @ 6:01 AM
Study NCT ID:
NCT05106569
Status:
UNKNOWN
Last Update Posted:
2023-06-13
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telespirometry in Amyotrophic Lateral Sclerosis (ALS)
Sponsor:
State University of New York - Upstate Medical University
Organization:
Study Overview
Official Title:
Home-Based Spirometry Through Telemedicine in Amyotrophic Lateral Sclerosis (ALS)
Status:
UNKNOWN
Status Verified Date:
2023-06
Last Known Status:
ENROLLING_BY_INVITATION
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:
None
Brief Summary:
The investigators seek to validate Slow Vital Capacity (SVC) measurement in seated and supine positions using conventional and portable spirometry.
Detailed Description:
SVC is obtained with in-clinic conventional spirometry, in-clinic portable spirometry, and in-home portable spirometry with respiratory therapist-supervised remote pulmonary function testing every two weeks in a six month prospective study of participants with a diagnosis of Amyotrophic Lateral Sclerosis. SVC decline over time, seated and supine, will be tracked with assessments for treatment changes.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: