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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Chronic Obstructive Pulmonary Disease (COPD); Cystic Fibrosis (CF); Non Cystic Fibrosis Bronchiectasis
• Intervention / Treatment: Device: Airway clearance therapy through acoustic oscillations

Detailed Description

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 preliminary comparison with the standard of care ACT device High Frequency Chest Wall Oscillation (HFCWO).

The study will be an iterative preliminary non-randomized pilot test to assess the translation of the SA1 RL algorithm from in-vitro models (3D lung and animal) to diseased human lungs. The subjects will use and provide feedback on the user interface and ease of operability of the prototype device. The software algorithm will be fine-tuned based on the clinical outcomes of the study. Participants have already had ≥2 ACT recent clinic sessions with the VEST device in the past 6 months to provide an estimate of the therapy outcomes, and the metrics will be compared against those obtained for the SonoHeal device. The primary outcomes will be qualitative; subjects will be interviewed and encouraged to verbalize their experience using the FDA-recommended Cognitive Walk-Through evaluation, and responses will be recorded for review and design improvements in the next stage. The quantitative outcome variables will be wet sputum weight and pre-post changes in resistance and FEV1 for preliminary comparison with the VEST for assessing algorithm performance. The sample size required is determined from the goal of identifying >90% of initial issues with the prototype device. Initially, N = 3 subjects in 3 sessions will be enrolled to evaluate and identify >90% of algorithmic, operational, and usability difficulties (problem discovery rate 70%, total n=9 sessions). Subsequently, N= 12 will be enrolled. The subjects will also undergo the personalization training session to optimize the algorithm parameters for each subject's unique response to airway clearance therapy.

Based on the results of Stage I experiments, the improved prototype device will be used for more extensive usability testing in the future.

• Study Type: Observational
• Enrollment (Estimated): 15

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Ana, California, United States, 92701-3515
      • Ventura County Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Usability Questionnaire Assessment	The subject will answer a 10-question system usability questionnaire to assess the ease of use of the system after each ACT session.	Day1 Post-treatment (within 1 hour).
Wet weight of sputum	The wet weight of sputum expectorated by the subject during and post ACT.	Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
Spirometry	Spirometry parameters of FEV1, PEF, FVC, FEV6. The nurse or respiratory therapist will conduct the spirometry test.	Day 1: Baseline (pre-treatment), and 20 minutes post-treatment
Airway impedance	Airway impedance parameters as measured by Forced Oscillation Technique: Impedance parameters at multiple frequencies from 5-30 Hz: R5, R10, R15, R20, R25, R30 and X5, X10, X15, X20, X25, X30.; Difference of resistances: R5-R20 (small airway resistance); fres = Frequency at which Reactance, X, is 0 (zero-crossing); AX = Area under the Reactance -X curve; Rinsp, Rexp, Xinsp, Xexp - Inspiratory and Expiratory resistance and reactance, within breath analysis. The nurse or respiratory therapist will conduct the FOT test.	Day 1: Baseline (pre-treatment), and 20 minutes post-treatment

Collaborators and Investigators

• Sponsor: Cognita Labs LLC
• Collaborators: University of California, Los Angeles; Ventura County Medical Center
• Investigators: Principal Investigator: Chris Landon, M.D., Ventura County Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 22, 2026
• First Submitted That Met QC Criteria: April 29, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Airway Clearance
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Diseases, Obstructive; Pancreatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Cystic Fibrosis
• Other Study ID Numbers: SonoHeal

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No