Oscillation and Lung Expansion (OLE) for Treatment of Neuromuscular Disease Patients
- Conditions
- Neuromuscular Diseases
- Interventions
- Device: Oscillation and Lung Expansion (OLE) therapy
- Registration Number
- NCT05366010
- Lead Sponsor
- Baxter Healthcare Corporation
- Brief Summary
The study will be a non-randomized open label pilot study using an observational design 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
- Documented diagnosis of neuromuscular disease (NMD)
- Age 5-80 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 OLE therapy as directed
- Signed informed consent (and assent if minor subject)
- Diagnosis with rapidly progressing NMD such as certain types of Motor Neuron Disease (MND)
- Anticipated requirement for hospitalization within the next six months
- History of pneumothorax within past 6 months
- History of hemoptysis requiring embolization within past 12 months
- Pregnancy
- Use of OLE therapy within the past 12 months
- Inability or unwillingness to perform OLE therapy or study procedures as required
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Intervention Oscillation and Lung Expansion (OLE) therapy Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
- Primary Outcome Measures
Name Time Method Frequency of exacerbations of pulmonary disease requiring medical intervention 6 months 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
- Secondary Outcome Measures
Name Time Method Number of outpatient visits for pulmonary complications 6 months Unscheduled Physician's office, Urgent Care Visits, ED visits
Satisfaction with OLE therapy 6 months. Satisfaction assessed by questionnaire administered at baseline and at 1, 3 and six months. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is 5 - 40. 40 = Highest Satisfaction
Number of ICU admissions 6 months for respiratory complications
Oxygen (O2) saturation Monthly for 6 months O2 Saturation will be measured while the subject is resting using a hand-held oximeter
Maximal Inspiratory Pressure Monthly for 6 months Maximal Inspiratory Pressure is the maximum force (measured in cmH20) that the subject can generate during an inspiratory effort
Number of hospitalizations 6 months for respiratory complications
Number of antibiotic use days during episodes of pneumonia 6 months Includes any of the following: IV antibiotic days, Oral antibiotic days, Nebulized antibiotic days
Number of inpatient hospital days 6 months For respiratory complications
Slow Vital Capacity Monthly for 6 months 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.
Peak Cough Flow Monthly for 6 months 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
Impact of OLE therapy on patient quality of life using the Severe Respiratory Insufficiency (SRI) questionnaire 6 months Severe Respiratory Insufficiency (SRI) questionnaire administered at baseline and at 1, 3 and six months. Scoring of the SRI is from 0 - 100. 100 = Best Quality of Life
Adherence to treatment regimen 6 months Adherence to the OLE treatment regimen will be determined by downloading device therapy log data
Trial Locations
- Locations (1)
Science 37
🇺🇸Durham, North Carolina, United States