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

Neuromuscular Diseases Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05366010
• Other study ID #: CR-RR-2020-005
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2021
• Est. completion date: April 2024

Study information

• Verified date: October 2023
• Source: Baxter Healthcare Corporation
• Contact: Brian Becker, MEd, RRT
• Phone: 16126001301
• Email: brian.becker[@]hillrom.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• Oscillation and Lung Expansion (OLE) therapy
Respiratory airway clearance intervention including continuous high-frequency oscillation and continuous positive expiratory pressure

Locations

Country	Name	City	State
United States	Science 37	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Hill-Rom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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.	Monthly for 6 months
Secondary	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	Monthly for 6 months
Secondary	Oxygen (O2) saturation	O2 Saturation will be measured while the subject is resting using a hand-held oximeter	Monthly for 6 months
Secondary	Maximal Inspiratory Pressure	Maximal Inspiratory Pressure is the maximum force (measured in cmH20) that the subject can generate during an inspiratory effort	Monthly for 6 months
Secondary	Number of hospitalizations	for respiratory complications	6 months
Secondary	Number of ICU admissions	for respiratory complications	6 months
Secondary	Number of outpatient visits for pulmonary complications	Unscheduled Physician's office, Urgent Care Visits, ED visits	6 months
Secondary	Number of antibiotic use days during episodes of pneumonia	Includes any of the following: IV antibiotic days, Oral antibiotic days, Nebulized antibiotic days	6 months
Secondary	Adherence to treatment regimen	Adherence to the OLE treatment regimen will be determined by downloading device therapy log data	6 months
Secondary	Number of inpatient hospital days	For respiratory complications	6 months
Secondary	Impact of OLE therapy on patient quality of life using the Severe Respiratory Insufficiency (SRI) questionnaire	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	6 months
Secondary	Satisfaction with OLE therapy	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	6 months.