NCT07568119Active, not recruiting
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 15 (estimated)
- First submitted
- 22 Apr 2026
- Start date
- Feb 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Cognita Labs LLC
- Diseases
- Cystic fibrosis, COPD
- NCT number
- NCT07568119
What you commit to
- Study type: Observational
- Planned participants: 15
- From Feb 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial in the previous 30 days.
Other
- 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.
- Use of intravenous antibiotics in the 2 months preceding enrollment.
- Inability or unwillingness of the participant to give written informed consent.
Who the study is looking for
- 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.
Age in the registry: 11 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ventura County Medical Center Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.