Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care

Korábbi kezelés

• Participation in another clinical trial in the previous 30 days.

Egyéb

• Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
• Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
• Chronic chest pain.
• Use of intravenous antibiotics in the 2 months preceding enrollment.
• Inability or unwillingness of the participant to give written informed consent.

• Diagnosis of CF established by either genetic screening or positive chloride sweat test (Sweat chloride concentrations > 60mmol/L).
• Diagnosis of NCFB or COPD requiring regular use of airway clearance therapy.
• Age older than 11 years.
• History of chronic daily sputum production.
• Currently on a home therapeutic regimen that includes some form of ACT performed at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
• Stage I eligibility for the 3 subjects will require patients who have had ≥2 ACT session with the VEST® in-clinic with lung function measured pre-post therapy.
• FVC and FEV1 > 35%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 2 months).
• Evaluated at the Ventura County Medical Center 2 or more times in the preceding 12 months.
• Signed informed consent given by the subject, or the parents, or a legally acceptable representative. If required by the Institutional Review Board/Ethics Committee (IRB/IEC), assent will be given by the subject.
• Ability to understand study requirements and comply with study procedures. Individuals of all ethnicities are included.