Neuromuscular DiseasesNCT05366010
Oscillation and Lung Expansion (OLE) Therapy for Treatment of Neuromuscular Disease (NMD) Patients
A study testing Oscillation and Lung Expansion (OLE) therapy in people with Neuromuscular Diseases, run by Baxter Healthcare Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- Oscillation and Lung Expansion (OLE) therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2021to 27 Feb 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuromuscular Diseases
- Being tested
- Oscillation and Lung Expansion (OLE) therapy
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oscillation and Lung Expansion (OLE) therapyDevice
Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention Receives: Device: Oscillation and Lung Expansion (OLE) therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months pre-treatment and 6 months post-treatment with the Volara System
Secondary outcomes (16)
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.
Measured: 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.
Measured: Baseline and monthly for 6 months
Resting Oxygen Saturation
Oxygen Saturation will be measured while the subject is resting using a hand-held oximeter.
Measured: 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.
Measured: Baseline and monthly for 6 months
Number of Hospital Admissions
Number of hospital admissions for respiratory complications.
Measured: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Total Hospital Length of Stay
Number of inpatient hospital days for respiratory complications
Measured: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Number of Intensive Care Unit (ICU) Admissions
Number of ICU admissions for respiratory complications.
Measured: 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
Number of ICU hospital days for respiratory complications
Measured: 6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System
Number of Outpatient Visits for Pulmonary Complications
Number of unscheduled Physician's office visits, urgent care visits, and emergency department (ED) visits.
Measured: 6 months pre-treatment and 6 months post-treatment with the Volara System
Total Number of Antibiotic Use Days During Episodes for Respiratory Infection
The total number of antibiotic use days includes any of the following: intravenous (IV) antibiotic days, oral antibiotic days, and nebulized antibiotic days.
Measured: 6 months pre-treatment and 6 months post-treatment with the Volara System
Adherence to Treatment Regimen: Average Daily Volara System Usage
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.
Measured: 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
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.
Measured: Baseline, and after 1 month, 3 months, and 6 months of therapy using the Volara System
Satisfaction With Current Airway Clearance Therapy at 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.
Measured: Baseline
Satisfaction With OLE Therapy 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.
Measured: After 1 month of using the Volara System
Satisfaction With OLE Therapy 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.
Measured: After 3 months of using the Volara System
Satisfaction With OLE Therapy 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.
Measured: After 6 months of using the Volara System
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start4 Nov 2021
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neuromuscular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study subjects will serve as their own control. Medical records will be reviewed for each study subject for the twelve-month period prior to initiation of OLE therapy. The study will compare the frequency of exacerbations experienced prior to treatment with OLE to the frequency of exacerbations experienced in the active treatment period, during which study subjects receive treatment with The Volara® System. In addition, specific healthcare utilization indicators including hospitalizations, antibiotic use, and emergency department (ED) visits for pulmonary complications will be documented for each study period.
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Science 37
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366010
- Sponsor's protocol ID
- CR-RR-2020-005
- Status last verified
- Jul 2025
- First submitted
- 27 Apr 2022
- Last updated
- 31 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05366010
- Acronym / sponsor ID
- CR-RR-2020-005
- Conditions
- Neuromuscular Diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Science 37
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 31 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study subjects will serve as their own control. Medical records will be reviewed for each study subject for the twelve-month period prior to initiation of OLE therapy. The study will compare the frequency of exacerbations experienced prior to treatment with OLE to the frequency of exacerbations experienced in the active treatment period, during which study subjects receive treatment with The Volara® System. In addition, specific healthcare utilization indicators including hospitalizations, antibiotic use, and emergency department (ED) visits for pulmonary complications will be documented for each study period.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Oscillation and Lung Expansion (OLE) therapyIntervention time period, during which all subjects receive OLE therapy as their airway clearance intervention |
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oscillation and Lung Expansion (OLE) therapyRespiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure | Device | Intervention |
Primary outcome
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
16 secondary outcomes
Slow Vital Capacity
Time frame: Baseline and monthly for 6 months
Peak Cough Flow
Time frame: Baseline and monthly for 6 months
Resting Oxygen Saturation
Time frame: Baseline and monthly for 6 months
Maximal Inspiratory Pressure
Time frame: 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
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 Intensive Care Unit (ICU) Admissions
Time frame: 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 Outpatient Visits for Pulmonary Complications
Time frame: 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
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)
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
Satisfaction With Current Airway Clearance Therapy at Baseline
Time frame: Baseline
Satisfaction With OLE Therapy After 1 Month of Using the Volara System
Time frame: 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 With OLE Therapy After 6 Months of Using the Volara System
Time frame: After 6 months of using the Volara System
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oscillation and Lung Expansion (OLE) therapy in people with Neuromuscular Diseases, run by Baxter Healthcare Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention (time frame: 6 months pre-treatment and 6 months post-treatment with the Volara System). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.