Status:
TERMINATED
Oscillation and Lung Expansion (OLE) Therapy for Treatment of Neuromuscular Disease (NMD) Patients
Lead Sponsor:
Baxter Healthcare Corporation
Collaborating Sponsors:
Science 37
Conditions:
Neuromuscular Diseases
Eligibility:
All Genders
5-80 years
Phase:
NA
Brief Summary
The study will be a non-randomized open label pilot study comparing a retrospective control period to an active treatment period with oscillation and lung expansion (OLE) therapy.
Detailed 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 neuromu...
Eligibility Criteria
Inclusion
- Patients who met all the following inclusion criteria are included in the study:
- Documented diagnosis of neuromuscular disease (NMD) or neurological disorder.
- Age 5 to 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 Oscillation and Lung Expansion (OLE) therapy as directed.
- Signed informed consent (and assent if minor patient).
- Patients who meet any of the following criteria will be excluded from the study:
- Diagnosis with rapidly progressing NMD such as certain types of Motor Neuron Disease (MND).
- Requirement for continuous mechanical ventilation.
- Anticipated requirement for respiratory related hospitalization within the next six months.
- History of pneumothorax within the past 6 months.
- History of hemoptysis requiring embolization within past 12 months.
- Pregnancy.
- Home use of OLE therapy within the past 12 months.
- Inability or unwillingness to perform OLE therapy or study procedures as required.
Exclusion
Key Trial Info
Start Date :
November 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT05366010
Start Date
November 4 2021
End Date
February 27 2024
Last Update
July 31 2025
Active Locations (1)
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1
Science 37
Durham, North Carolina, United States, 27709