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

Baxter Healthcare Corporation41 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Neuromuscular Diseases

Interventions

Oscillation and Lung Expansion (OLE) therapyDEVICE

Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

Eligibility

Sex: ALLMin age: 5 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Science 37

Durham, North Carolina, United States

Outcomes

Primary Outcomes

Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention

Exacerbation of pulmonary disease is a worsening of pulmonary condition or an event requiring one or more of the following: * Hospitalization * Emergency Department visit * Unscheduled antibiotics * Unscheduled outpatient visit

Time frame: 6 months pre-treatment and 6 months post-treatment with the Volara System

Secondary Outcomes

Slow Vital Capacity

Slow Vital Capacity is the maximum volume that the subject can exhale in a single breath, following full inspiration. The measure is taken using a slow consistent exhalation.

Time frame: Baseline and monthly for 6 months

Peak Cough Flow

Peak Cough Flow is a pulmonary function measure that evaluates maximum peak flow generated during a cough maneuver. It will be measured with a hand-held spirometer.

Time frame: Baseline and monthly for 6 months

Resting Oxygen Saturation

Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.

Time frame: Baseline and monthly for 6 months

Maximal Inspiratory Pressure

Maximal Inspiratory Pressure is the maximum force (measured in centimeters of water \[cmH2O\]) that the subject can generate during an inspiratory effort.

Time frame: Baseline and monthly for 6 months

Number of Hospital Admissions

Number of hospital admissions for respiratory complications.

Time frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System

Data from ClinicalTrials.gov

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