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

The study aims to evaluate the measurement accuracy of respiratory impedance during oscillometry (or Forced Oscillation Technique - FOT) under the following conditions: 1)The subject's cheeks are manually supported by an expert (Gold Standard method), 2) The subject's cheeks are supported by an integrated cheek support in the mouthpiece. It is a prospective, randomized, cross-over study on Subjects who will present themselves at the offices of the participating doctors, aged between 5 and 75 years. The primary outcome is to Compare the respiratory impedance measurements under the two measurement conditions. Secondary Objectives are to: i)evaluate the patient's comfort during the measurement with the cheek support and compare this comfort to the gold standard condition; ii) assess the maximum and minimum face dimensions of the recruited subjects that allow for effective and comfortable cheek support; iii) evaluate the type and frequency of measurement errors introduced by the use of the integrated cheek support in the mouthpiece.

NCT Number	NCT06537362
Lead Sponsor	Politecnico di Milano
Conditions	Respiratory Morbidity, Lung Function Decreased
Enrollment	55 participants
Start Date	2024-03-26
Primary Completion	2024-08 (estimated)
Study Completion	2024-08 (estimated)
Updated on ClinicalTrials.gov	2024-08-28