Cystic Fibrosis Clinical Trial
Official title:
Evaluation of Device Settings for Airway Clearance Using The Monarch Airway Clearance System
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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