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

July 30, 2025 updated by: Baxter Healthcare Corporation

Evaluation of Oscillation and Lung Expansion (OLE) Using The Volara® System for Treatment of Respiratory Complications in Patients With Neuromuscular Disease in the Home Setting

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
41

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27709
        • Science 37

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
Device: Oscillation and Lung Expansion (OLE) therapy
Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention
Time Frame: 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
6 months pre-treatment and 6 months post-treatment with the Volara System

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Slow Vital Capacity
Time Frame: 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.
Baseline and monthly for 6 months
Peak Cough Flow
Time Frame: 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.
Baseline and monthly for 6 months
Resting Oxygen Saturation
Time Frame: Baseline and monthly for 6 months
Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.
Baseline and monthly for 6 months
Maximal Inspiratory Pressure
Time Frame: 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.
Baseline and monthly for 6 months
Number of Hospital Admissions
Time Frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Number of hospital admissions for respiratory complications.
6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Total Hospital Length of Stay
Time Frame: 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
6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Number of Intensive Care Unit (ICU) Admissions
Time Frame: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Number of ICU admissions for respiratory complications.
6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Total Intensive Care Unit (ICU) Length of Stay
Time Frame: 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
6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Number of Outpatient Visits for Pulmonary Complications
Time Frame: 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.
6 months pre-treatment and 6 months post-treatment with the Volara System
Total Number of Antibiotic Use Days During Episodes for Respiratory Infection
Time Frame: 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.
6 months pre-treatment and 6 months post-treatment with the Volara System
Adherence to Treatment Regimen: Average Daily Volara System Usage
Time Frame: 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.
Total number of days the subject had the device (approximately up to 6 months of OLE therapy)
Impact of OLE Therapy on Patient Quality of Life Using the Respiratory Complaints Domain of the Severe Respiratory Insufficiency (SRI) Questionnaire
Time Frame: 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.
Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara System
Satisfaction With Current Airway Clearance Therapy at Baseline
Time Frame: 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.
Baseline
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Time Frame: 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.
After 1 month of using the Volara System
Satisfaction With OLE Therapy After 3 Months of Using the Volara System
Time Frame: 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.
After 3 months of using the Volara System
Satisfaction With OLE Therapy After 6 Months of Using the Volara System
Time Frame: 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.
After 6 months of using the Volara System

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Baxter Healthcare Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Science 37

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 4, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 27, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 27, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR-RR-2020-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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