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NCT07568119

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

StatusActive, Not Recruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved 2 years later.

See at-risk trials from Cognita Labs LLC

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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Jun 30, 2026 to Jun 30, 2028
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Study description revised
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Qualitative assessment
Timeframe: Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
Time taken for training session
Timeframe: Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
Time taken for therapy duration
Timeframe: Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).

Secondary (4)

System Usability Questionnaire Assessment
Wet weight of sputum
Spirometry
Airway impedance

Arms and interventions

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.

Devices: Airway clearance therapy through acoustic oscillations

Sites

1 site in 1 country

  • Ventura County Medical CenterSanta Ana, California, United States