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

Not Applicable

Terminated

• Conditions: Neuromuscular Diseases

• Registration Number: NCT05366010
• Lead Sponsor: Baxter Healthcare Corporation

Brief 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.

Study Timeline

• Study Start: 2021-11-04
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-05-04
• Study First Posted: 2022-05-09
• Primary Completion: 2024-02-27
• Study Completion: 2024-02-27
• Results First Submitted: 2025-03-06
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Results First Posted: 2025-07-31
• Last Update Posted: 2025-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention	6 months pre-treatment and 6 months post-treatment with the Volara System	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 Hospital Admissions	6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System	Number of hospital admissions for respiratory complications.
Slow Vital Capacity	Baseline and 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	Baseline and 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.
Resting Oxygen Saturation	Baseline and monthly for 6 months	Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.
Maximal Inspiratory Pressure	Baseline and monthly for 6 months	Maximal Inspiratory Pressure is the maximum force (measured in centimeters of water \[cmH2O\]) that the subject can generate during an inspiratory effort.
Number of Intensive Care Unit (ICU) Admissions	6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System	Number of ICU admissions for respiratory complications.
Total Hospital Length of Stay	6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System	Number of inpatient hospital days for respiratory complications
Total Intensive Care Unit (ICU) Length of Stay	6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System	Number of ICU hospital days for respiratory complications
Number of Outpatient Visits for Pulmonary Complications	6 months pre-treatment and 6 months post-treatment with the Volara System	Number of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits.
Total Number of Antibiotic Use Days During Episodes for Respiratory Infection	6 months pre-treatment and 6 months post-treatment with the Volara System	The total number of antibiotic use days includes any of the following: intravenous (IV) antibiotic days, oral antibiotic days, and nebulized antibiotic days.
Adherence to Treatment Regimen: Average Daily Volara System Usage	Total number of days the subject had the device (approximately up to 6 months of OLE therapy)	Adherence to the OLE treatment regimen was presented as Average Daily Volara System Usage. This was calculated by dividing the total minutes of device use by the total number of days the subject had the device.
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire	Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara System	Severe Respiratory Insufficiency (SRI) questionnaire administered at baseline, and at 1, 3 and 6 months. The total score can range from a minimum of 0 to a maximum of 100 with higher values indicating a better health-related quality of life according to content of the scale.
Satisfaction With Current Airway Clearance Therapy at Baseline	Baseline	Satisfaction is assessed through a questionnaire administered at baseline. Seven satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 35, with 35 indicating the highest satisfaction.
Satisfaction With OLE Therapy After 1 Month of Using the Volara System	After 1 month of using the Volara System	Satisfaction is assessed through a questionnaire administered after 1 month of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Satisfaction With OLE Therapy After 3 Months of Using the Volara System	After 3 months of using the Volara System	Satisfaction is assessed through a questionnaire administered after 3 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.
Satisfaction With OLE Therapy After 6 Months of Using the Volara System	After 6 months of using the Volara System	Satisfaction is assessed through a questionnaire administered after 6 months of therapy using the Volara System. Eight satisfaction questions are assessed using a Five-point Likert Scale. Total score is from 5 to 40, with 40 indicating the highest satisfaction.

Trial Locations

Locations (1)

Science 37; 🇺🇸 Durham, North Carolina, United States