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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
Intervention
Intervention time period, during which all subjects receive OLE therapy as their airway clearance intervention
干预措施: Oscillation and Lung Expansion (OLE) therapy (Device)
结局指标
主要结局
Frequency of Exacerbations of Pulmonary Disease Requiring Medical Intervention
时间窗: 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
次要结局
- Resting Oxygen Saturation(Baseline and monthly for 6 months)
- Maximal Inspiratory Pressure(Baseline and monthly for 6 months)
- Number of Hospital Admissions(6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System)
- Slow Vital Capacity(Baseline and monthly for 6 months)
- Peak Cough Flow(Baseline and monthly for 6 months)
- Number of Intensive Care Unit (ICU) Admissions(6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System)
- Total Hospital Length of Stay(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(6 months pre-treatment with the Volara System and 6 months post-treatment with the Volara System)
- Number of Outpatient Visits for Pulmonary Complications(6 months pre-treatment and 6 months post-treatment with the Volara System)
- Total Number of Antibiotic Use Days During Episodes for Respiratory Infection(6 months pre-treatment and 6 months post-treatment with the Volara System)
- 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))
- 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)
- Satisfaction With Current Airway Clearance Therapy at Baseline(Baseline)
- Satisfaction With OLE Therapy After 1 Month of Using the Volara System(After 1 month of using the Volara System)
- Satisfaction With OLE Therapy After 3 Months of Using the Volara System(After 3 months of using the Volara System)
- Satisfaction With OLE Therapy After 6 Months of Using the Volara System(After 6 months of using the Volara System)