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

Baxter

Status: Terminated

Conditions: Neuromuscular Diseases

Treatments: Device: Oscillation and Lung Expansion (OLE) therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT05366010

CR-RR-2020-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 5 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

41 participants in 1 patient group

Intervention

Experimental group

Description:

Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention

Treatment:

Device: Oscillation and Lung Expansion (OLE) therapy