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

The proposed study is to gauge the early feasibility and acceptance of the SonoHeal device. The study will evaluate the usability of the SonoHeal prototype using well-established Human Factors Engineering methods recommended by the FDA. The investigators will also obtain preliminary comparison with the standard of care ACT device High Frequency Chest Wall Oscillation (HFCWO).

The study will be an iterative preliminary non-randomized pilot test to assess the translation of the SA1 RL algorithm from in-vitro models (3D lung and animal) to diseased human lungs. The subjects will use and provide feedback on the user interface and ease of operability of the prototype device. The software algorithm will be fine-tuned based on the clinical outcomes of the study. Participants have already had ≥2 ACT recent clinic sessions with the VEST device in the past 6 months to provide an estimate of the therapy outcomes, and the metrics will be compared against those obtained for the SonoHeal device. The primary outcomes will be qualitative; subjects will be interviewed and encouraged to verbalize their experience using the FDA-recommended Cognitive Walk-Through evaluation, and responses will be recorded for review and design improvements in the next stage. The quantitative outcome variables will be wet sputum weight and pre-post changes in resistance and FEV1 for preliminary comparison with the VEST for assessing algorithm performance. The sample size required is determined from the goal of identifying >90% of initial issues with the prototype device. Initially, N = 3 subjects in 3 sessions will be enrolled to evaluate and identify >90% of algorithmic, operational, and usability difficulties (problem discovery rate 70%, total n=9 sessions). Subsequently, N= 12 will be enrolled. The subjects will also undergo the personalization training session to optimize the algorithm parameters for each subject's unique response to airway clearance therapy.

Based on the results of Stage I experiments, the improved prototype device will be used for more extensive usability testing in the future.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Participation in another clinical trial in the previous 30 days.
• Use of intravenous antibiotics in the 2 months preceding enrollment.
• Inability or unwillingness of the participant to give written informed consent.