Overview
The study will be a non-randomized open label pilot study using an observational design comparing a retrospective control period to an active treatment period with oscillation and lung expansion (OLE) therapy.
Description
The study is a decentralized trial. all data will be collected in the patients' homes. The primary objective of the study is to evaluate the impact of OLE to treat respiratory complications of neuromuscular disease patients. The frequency of pulmonary exacerbations and other clinical outcome measures will be assessed to determine the effect of consistent OLE therapy.
Eligibility
Inclusion Criteria:
- Documented diagnosis of neuromuscular disease (NMD)
- Age 5-80 years
- History of one or more respiratory exacerbations in the past 6 months or two or more respiratory exacerbations in the past 12 months, which required unplanned or unscheduled medical intervention.
- Ability to perform OLE therapy as directed
- Signed informed consent (and assent if minor subject)
Exclusion Criteria:
- Diagnosis with rapidly progressing NMD such as certain types of Motor Neuron Disease (MND)
- Anticipated requirement for hospitalization within the next six months
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Pregnancy
- Use of OLE therapy within the past 12 months
- Inability or unwillingness to perform OLE therapy or study procedures as required