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

Running, not enrolling

Conditions studied: Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis, Chronic Obstructive Pulmonary Disease (COPD)

In brief

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 a preliminary comparison with the standard of care ACT device, High Frequency Chest Wall Oscillation (HFCWO).

Key facts

Study ID

NCT07568119

Run by

Cognita Labs LLC

People needed

15

Starts

2024-02-17

Expected to finish

2026-06-30

Last updated by the study team

2026-05-05

Who can join

Age: 11 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ventura County Medical Center — Santa Ana, California, United States

Full record on ClinicalTrials.gov

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