NCT05366010

Oscillation and Lung Expansion (OLE) Therapy for Treatment of Neuromuscular Disease (NMD) Patients

Evaluation of Oscillation and Lung Expansion (OLE) Using The Volara® System for Treatment of Respiratory Complications in Patients With Neuromuscular Disease in the Home Setting

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Baxter Healthcare Corporation · Industry
• Sex: All
• Age: 5 Years – 80 Years
• Healthy volunteers: Not accepted

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 neuromuscular disease patients. The frequency of pulmonary exacerbations and other clinical outcome measures will be assessed to determine the effect of consistent OLE therapy.

Conditions

• Neuromuscular Diseases

Interventions

Type	Name	Description
DEVICE	Oscillation and Lung Expansion (OLE) therapy	Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

Timeline

• Start date: 2021-11-04
• Primary completion: 2024-02-27
• Completion: 2024-02-27
• First posted: 2022-05-09
• Last updated: 2025-07-31
• Results posted: 2025-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study