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The study will be an open label laboratory study with all subjects receiving HFCWO with The Monarch® System
Objective:
Assess device settings and to identify frequency/pressure (intensity) combinations that produce high airflow and oscillating volume
Methodology:
Subjects will receive HFCWO using The Monarch® System at multiple frequency / intensity combinations on a single visit day. Frequency / intensity combinations will be evaluated to determine which settings produce highest airflow and highest oscillating volume.
The study will be an open-label, laboratory study. All enrolled subjects will receive HFCWO therapy with the Monarch® system. The study will be conducted at one (1) site in the US.
The study will evaluate oscillating airflow and oscillating volume induced during therapy with the Monarch® system. Subjects will also rate the comfort of the therapy. Patients with cystic fibrosis (CF) who meet all of the inclusion criteria and none of the exclusion criteria will be enrolled in the study.
Therapy with the Monarch® system will be delivered using multiple frequency/intensity combination settings. The order of settings will be randomized for each study subject. During therapy oscillating flow and volume measurements will be obtained for each frequency/intensity combination. Following each frequency/intensity combination, subjects will respond to a subjective assessment of the comfort of the therapy by rating the comfort on a visual analogue scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Monarch device settings assessment group | Experimental | Patients with cystic fibrosis who have experience with the Monarch Airway Clearance System will be enrolled in the study. The duration of subject participation is approximately 4 - 6 hours during 1 study visit. Each subject will receive therapy with The Monarch® System at multiple frequency and intensity combinations as defined in the Study procedures. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Monarch Airway Clearance System | Device | HFCWO Airway Clearance Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Peak oscillating expiratory airflow measurements | Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings. After adjusting the therapy to the desired setting, subjects will be instructed breath through the mouthpiece for the flow measurement system, to breathe normally and continue relaxed breathing. Oscillating flow and volume measurement will be captured by the system over a period of 30 to 60 seconds of relaxed breathing. Data from the measurement of oscillating flow for each frequency/intensity combination setting will be processed following the completion of the testing | 4-6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Oscillating volume | Oscillating volume measurement will be conducted concurrently with the measurement of flow. Subjects will be treated with the Monarch® system using multiple frequency/intensity combination settings as described above. Data from the measurement of oscillating volume for each frequency/intensity combination setting will be processed following the completion of the testing | 4-6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Patient comfort/discomfort evaluated by 100 mm visual analogue scale (VAS) | Following the completion of testing for each frequency/intensity combination setting, subjects will rate the level of comfort/discomfort of the setting on a VAS. A Visual Analogue Scale is a psychometric response scale which will be used as a measuring instrument for subjective comfort or discomfort. It is a measurement instrument that ranges across a continuum of values and used to measure the intensity or frequency of various symptoms.
The subject will mark the line for each setting combination to indicate the level of comfort or discomfort. After the Study visit, the research staff will measure the mark on the line and document the value. | 4-6 hours |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |