Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the S… (NCT07568119) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Feasibility and Acceptance of SonoHeal for Airway Clearance and Preliminary Comparison With the Standard of Care
United States15 participantsStarted 2024-02-17
Plain-language 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).
Who can participate
Age range
11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Qualitative assessment
Timeframe: Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
2
Time taken for training session
Timeframe: Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).
3
Time taken for therapy duration
Timeframe: Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour).