Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-06-16 @ 7:43 PM
Study NCT ID:
NCT02354651
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2015-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Response to Diaphragmatic Pacing in Subjects With Pompe Disease
Sponsor:
University of Florida
Organization:
Study Overview
Official Title:
Response to Diaphragmatic Pacing in Subjects With Pompe Disease
Status:
COMPLETED
Status Verified Date:
2023-07
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:
The purpose of this study is to determine the effect of diaphragm pacing on respiratory function in subjects with Pompe disease by evaluating the duration and pattern of spontaneous respiratory function versus paced ventilation respiratory function in patients with Pompe disease who have received the NeuDx Diaphragm pacer (DPS).
Detailed Description:
Subjects with Pompe disease who are scheduled to receive a NeuRx Diaphragm pacer (DPS) will be invited to participate in this study. The following tests will be performed during participation in the study:
1. Forced expiratory tests
2. Maximal Inspiratory Pressure (MIP)
3. Resting Breathing Pattern
4. Phrenic Nerve Function Evaluation with EMG
5. Severe Respiratory Insufficiency Questionnaire
6. Magnetic stimulation
7. Diaphragm conditioning consisting of:
1. The external stimulator settings
2. The duration of diaphragm stimulation
3. Off-ventilator spontaneous breathing (SB)
1. Forced expiratory tests
2. Maximal Inspiratory Pressure (MIP)
3. Resting Breathing Pattern
4. Phrenic Nerve Function Evaluation with EMG
5. Severe Respiratory Insufficiency Questionnaire
6. Magnetic stimulation
7. Diaphragm conditioning consisting of:
1. The external stimulator settings
2. The duration of diaphragm stimulation
3. Off-ventilator spontaneous breathing (SB)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 003-2013 | OTHER | University of Florida pre-conversion | View | |
| 1R21HD090752-01 | NIH | None | https://reporter.nih.gov/quic… | View |