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

NCT07568119 · tracked via the Priya Life Science USA tracker

Sponsor

Cognita Labs LLC

Phase

Observational

Started

2024-02-17

Last updated

2026-05-05

Condition(s) studied

Cystic Fibrosis (CF)Non Cystic Fibrosis BronchiectasisChronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

Airway clearance therapy through acoustic oscillations

Airway clearance therapy through acoustic oscillations: The investigational intervention is the SonoHeal device, an adaptive airway clearance therapy (ACT) system designed to enhance mucus mobilization through individualized pressure/acoustic oscillations. The device utilizes the Forced Oscillation Technique (FOT) to continuously measure respiratory impedance, including airway resistance and reactance, during therapy. During each treatment session, patients use the SonoHeal device for a defined duration consistent with standard ACT practices. The device delivers high-frequency pressure oscillations intended to loosen and mobilize mucus within the airways, facilitating expectoration. Outcome measures associated with the intervention include changes in lung function parameters (e.g., resistance and reactance), sputum production during therapy, and overall treatment response.

Study summary

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).

Eligibility

Sex

ALL

Min age

11 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Qualitative assessment — Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
The patients will describe their experience during the therapy using the Cognitive Walk Through Evaluation
Time taken for training session — Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
The time taken during the first training session will be measured.
Time taken for therapy duration — Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
The time taken for therapy during each session will be recoded.

Trial sites (1)

Facility	City	Region	Status
Ventura County Medical Center	Santa Ana	California

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07568119 on ClinicalTrials.gov ↗ ← All trials in the USA