Chronic Obstructive Pulmonary Disease (COPD), Cystic Fibrosis (CF), Non Cystic Fibrosis Bronchiectasis
Conditions
Keywords
Airway Clearance
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).
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.
Interventions
DEVICEAirway 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.
Sponsors
Cognita Labs LLC
Ventura County Medical Center
University of California, Los Angeles
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment | Day 1: Baseline (pre-treatment), during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour). | The patients will describe their experience during the therapy using the Cognitive Walk Through Evaluation |
| Time taken for training session | Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour). | The time taken during the first training session will be measured. |
| Time taken for therapy duration | Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour). | The time taken for therapy during each session will be recoded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| System Usability Questionnaire Assessment | Day1 Post-treatment (within 1 hour). | The subject will answer a 10-question system usability questionnaire to assess the ease of use of the system after each ACT session. |
| Wet weight of sputum | Day 1 during treatment (up to 60 minutes), and immediately post-treatment (within 1 hour). | The wet weight of sputum expectorated by the subject during and post ACT. |
| Spirometry | Day 1: Baseline (pre-treatment), and 20 minutes post-treatment | Spirometry parameters of FEV1, PEF, FVC, FEV6. The nurse or respiratory therapist will conduct the spirometry test. |
| Airway impedance | Day 1: Baseline (pre-treatment), and 20 minutes post-treatment | Airway impedance parameters as measured by Forced Oscillation Technique: 1. Impedance parameters at multiple frequencies from 5-30 Hz: R5, R10, R15, R20, R25, R30 and X5, X10, X15, X20, X25, X30. 2. Difference of resistances: R5-R20 (small airway resistance) 3. fres = Frequency at which Reactance, X, is 0 (zero-crossing) 4. AX = Area under the Reactance -X curve 5. Rinsp, Rexp, Xinsp, Xexp - Inspiratory and Expiratory resistance and reactance, within breath analysis. The nurse or respiratory therapist will conduct the FOT test. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORChris Landon, M.D.
Ventura County Medical Center
Outcome results
None listed