Response to Diaphragmatic Pacing in Subjects With Pompe Disease

Status Completed

Clinical Trial 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).

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02354651
Study type	Observational
Source	University of Florida
Contact
Status	Completed
Phase
Start date	May 2013
Completion date	January 2023

View Details

See also
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