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ACTIVE NOT RECRUITING
NCT07568119

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

Sponsor: Cognita Labs LLC

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

11 Years - Any

Study Type

OBSERVATIONAL

Enrollment

15

Start Date

2024-02-17

Completion Date

2026-06-30

Last Updated

2026-05-05

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (1)

Ventura County Medical Center

Santa Ana, California, United States