Innovative Breathing Retraining Device: Phase-4 Validation of Clinical Efficacy in Healthy Adults

Background: Breathing retraining devices are widely used to improve lung function, respiratory muscle performance and breathing efficiency. Conventional devices often lack adjustable resistance, meaningful visual feedback or ergonomic design, which can limit training quality and patient engagement. A novel breathing retraining device was developed through sequential phases involving need analysis, engineering design and accuracy validation. Objectives: The study aimed to evaluate whether the newly designed device could produce measurable improvements in pulmonary function and inspiratory performance, and to determine its usability and acceptability among adult users. Methods: A two-week intervention study was conducted on healthy adults. Participants performed structured breathing retraining using the device under supervised and home-based sessions. Pulmonary function, inspiratory performance and user experience were assessed before and after the intervention. Results: Participants demonstrated notable improvements in key pulmonary parameters, including an increase in forced expiratory volume and sustained maximal inspiration. Inspiratory performance improved consistently across all users. User experience ratings indicated high satisfaction, with positive feedback regarding comfort, visual feedback clarity and ease of resistance adjustment. Conclusion: The novel breathing retraining device effectively enhances pulmonary function and inspiratory performance while offering excellent usability. The findings support its potential application in pulmonary rehabilitation and justify further clinical trials in populations with respiratory impairment.