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

NCT07568119 | Active Not Recruiting FDA Device

• 1 other identifier: SonoHeal
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

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

Keywords

Airway Clearance

Outcome Measures

Primary Outcomes (3)

• Qualitative assessment

  The patients will describe their experience during the therapy using the Cognitive Walk Through Evaluation

  Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).

• Time taken for training session

  The time taken during the first training session will be measured.

  Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).

• Time taken for therapy duration

  The time taken for therapy during each session will be recoded.

  Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).

Secondary Outcomes (4)

• System Usability Questionnaire Assessment

  Day1 Post-treatment (within 1 hour).

• Wet weight of sputum

  Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).

• Spirometry

  Day 1: Baseline (pre-treatment), and 20 minutes post-treatment

• Airway impedance

  Day 1: Baseline (pre-treatment), and 20 minutes post-treatment

Study Arms (1)

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.

Device: Airway clearance therapy through acoustic oscillations

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.

Observation Group

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from patients receiving routine clinical care for chronic airway diseases at Ventura County Medical Center and UCLA. This population includes adolescents and adults with established diagnoses of Cystic Fibrosis, Non-cystic fibrosis bronchiectasis, and Chronic Obstructive Pulmonary Disease who require ongoing airway clearance therapy (ACT) as part of standard disease management. Patients in this population are typically managed in outpatient pulmonary or specialty clinics and have longitudinal follow-up within the health system. They commonly experience chronic sputum production and utilize daily ACT in combination with inhaled therapies such as bronchodilators and mucolytics. The population represents individuals with stable, chronic disease who are capable of performing routine airway clearance treatments in both clinical and home settings.

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.

Sponsors & Collaborators

• Cognita Labs LLC: lead
• Ventura County Medical Center: collaborator
• University of California, Los Angeles: collaborator

Study Sites (1)

Ventura County Medical Center

Santa Ana, California, 92701-3515, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chris Landon, M.D.

  Ventura County Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 5, 2026
• Study Start: February 17, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

US (1)