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

Last updated: July 30, 2025
Sponsor: Baxter Healthcare Corporation
Overall Status: Terminated

Phase

N/A

Condition

Neurologic Disorders

Dystonias

Treatment

Oscillation and Lung Expansion (OLE) therapy

Clinical Study ID

NCT05366010
CR-RR-2020-005
  • Ages 5-80
  • All Genders

Study 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.

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.

Study Design

Total Participants: 41
Treatment Group(s): 1
Primary Treatment: Oscillation and Lung Expansion (OLE) therapy
Phase:
Study Start date:
November 04, 2021
Estimated Completion Date:
February 27, 2024

Study 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.

Connect with a study center

  • Science 37

    Durham, North Carolina 27709
    United States

    Site Not Available

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