Loading search results

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 oscillationsDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age11 Years+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-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:

MeSH Terms

Conditions

Cystic FibrosisPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesLung Diseases, ObstructiveChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Observation Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (4)

Study Arms (1)

Observation Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations