Comparative Evaluation of Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry Measurements

What this Trial Is About

This study evaluates the accuracy of respiratory impedance measurements taken during oscillometry using two different cheek support methods: manual cheek support by an expert (the Gold Standard) and an integrated cheek support built into the mouthpiece. It is a prospective, randomized, cross-over trial involving subjects aged 5 to 75 years who visit participating doctors' offices. The primary goal is to compare the impedance measurements between these two methods. Secondary goals include assessing patient comfort, determining which face sizes allow effective cheek support, and analyzing measurement errors related to the cheek support device. Participants will undergo facial measurements including bigonial width and lip length while seated, followed by respiratory impedance tests using the Resmon FIRST device. Each participant will have two measurement sessions in random order: one with manual cheek support and one with the mouthpiece cheek support. Each session involves three repeated measurements over 10 breaths at 5 Hz oscillations. After measurements, participants complete a comfort questionnaire adapted from a respirator comfort instrument used during COVID-19. During the study visit, researchers will collect anatomical face measurements, perform respiratory tests, and gather comfort feedback. Data analysis will compare measurement differences to established variability thresholds and assess comfort scores. The study also evaluates face size impact on measurement accuracy and records any user-related errors. Total participation occurs within one session lasting about 15 minutes, with all procedures conducted under medical supervision.

Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry