CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Thoracic MRI +5 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02354664
NCT02354664N/ACompleted

Dynamic Respiratory Muscle Function in Late-Onset Pompe Disease

University of Florida·observational·Posted Feb 3, 2015·Updated Jun 24, 2024

In Brief

An observational study evaluating Thoracic MRI, Spirometry, and 4 other interventions for Pompe Disease. Completed, enrolled 14 participants across 1 site.

Detailed Summary

This study intends to evaluate dynamic respiratory motor performance as a valuable measure of pulmonary function in adults with late-onset Pompe disease. The investigators will adopt a strategy that includes comprehensive evaluations of respiratory volume, flow, and timing parameters during resting and loaded breathing. These evaluations will then be associated to the standard clinical measure of maximal inspiratory pressure, the static inspiratory muscle function, as well as magnetic resonance imaging of thoracic expansion and diaphragmatic descent at rest and with exertion. Outcomes in participants with late-onset Pompe disease will be contrasted to the function of age- and gender-matched control subjects. This approach will enable the investigators to evaluate the relationship between dynamic diaphragmatic function and respiratory motor function.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPompe Disease
CountriesUnited States

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 3, 2015
Enrollment StartApr 1, 2015
Primary CompletionOct 19, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.4 years ago

Interventions

Thoracic MRIother

Imaging of the diaphragm will be completed during resting breathing, and then during a maximal voluntary ventilation maneuver.

Spirometryother

Upright forced vital capacity (FVC)

Inspiratory Load Compensationother

A spring-loaded pressure device will resist inspiration. The patient must generate the threshold inspiratory pressure to receive airflow. The changes in breathing timing, flow and volume will be recorded.

Maximal Inspiratory Pressureother

Measure the maximal airflow on inhalation

Resting Breathing Patternother

The breathing pattern will be assessed when the subject is seated and in a relaxed state.

Respiratory Muscle Endurance Testother

Evaluates the time limit that a participant can maintain ventilation while breathing with a submaximal inspiratory threshold load.