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High Dose Inspiratory Muscle Training in LOPD

CompletedNA

Sponsor: Duke University

Conditions: Late-Onset Pompe Disease, Lysosomal Disease

Interventions: IMT therapy using the Pr02 mobile device

Countries: United States

Study Objectives: 1) assess the safety and feasibility of high-dose inspiratory muscle training (IMT) delivered remotely in Late-onset Pompe Disease (LOPD) and 2) determine its effects on respiratory and patient-reported outcomes.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Age ≥ 18 years
* Confirmed diagnosis of LOPD
* MIP \>50% of predicted for sex and age
* Stable on current Pompe disease treatment regimen \>6 months
* Able to follow directions for study participation
* Access to computer and smartphone/tablet with reliable internet connection for video visits and sensor-based respiratory technologies

Exclusion Criteria:

* Presence of medical comorbidities that prevent meaningful study participation (e.g., COPD GOLD III-IV, significant mental illness, dementia)
* Use of continuous invasive or non-invasive ventilation while awake
* Prior history of gene therapy for LOPD
* Inability to give legally effective consent
* Inability to read and understand English

Locations (1)

Durham, North Carolina, United States