Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-27 @ 11:46 AM
Study NCT ID:
NCT05003167
Status:
COMPLETED
Last Update Posted:
2023-06-08
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Sponsor:
Purdue University
Organization:
Study Overview
Official Title:
Effectiveness of Expiratory Muscle Strength Training for Improving Communication in ALS
Status:
COMPLETED
Status Verified Date:
2023-06
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:
None
Brief Summary:
A tele-health treatment study for individuals with early stage ALS with the aim to improve communication, cough response, and respiratory strength. All participants complete a respiratory strength training program using an Expiratory Muscle Strength Training (EMST 150) device from the comfort of their homes for 6 weeks.
Detailed Description:
The investigators are looking for people with early stage ALS to participate in a completely tele-health (no in-person visits required) treatment study examining the effects of an Expiratory Muscle Strength Training device (EMST-150) on communication, cough, and respiratory strength. Participants will be required to attend 2 virtual baseline assessment sessions followed by 12 additional virtual training sessions (2 per week for 6 weeks). Participants should plan to be actively enrolled in the study for \~10 weeks (3 weeks of baseline monitoring followed by 6 weeks of training). Participants will also be required to fill out a series of questionnaires assessing the EMST's effectiveness via tele-health.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 1F31DC019281-01 | NIH | None | https://reporter.nih.gov/quic… | View |