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

Part of paid clinical trials in Santa Ana, California.

Sponsor
Cognita Labs LLC
Study ID
NCT07568119
Status
Active Not Recruiting

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)
  • Cystic Fibrosis (CF)
  • Non Cystic Fibrosis Bronchiectasis

Eligibility Criteria

Sex
ALL
Age
11 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Airway clearance therapy through acoustic oscillations — DEVICE
    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 Details

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 Dates

Start date
Feb 17, 2024
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
15 participants (estimated)

Arms

  • Arm: Observation Group
    The study cohort consists of adolescent and adult patients (≥11 years of age) diagnosed with Cystic Fibrosis, Non-cystic fibrosis bronchiectasis, or Chronic Obstructive Pulmonary Disease who require ongoing airway clearance therapy (ACT) as part of their standard disease management. These individuals have a history of chronic daily sputum production and are maintained on a stable home regimen that includes routine ACT (at least once daily), along with concomitant use of inhaled mucolytics and bronchodilators. Participants are required to have relatively stable pulmonary status prior to enrollment, defined by lung function (FEV1 and FVC \>35% predicted) without significant variation (\>10%) over the preceding two months, and no recent pulmonary exacerbations. The study is observational at this stage to assess the feasibility and usability of the investigational SonoHeal device.

Primary Outcome Measure

Qualitative assessment [ Time Frame: Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ventura County Medical CenterSanta AnaCalifornia92701-3515-

Find similar trials in Santa Ana, CA

By research site
Ventura County Medical Center· Santa Ana, CA

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