Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry
Comparative Evaluation of the Use of a Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry Measurements
Politecnico di Milano
55 participants
Mar 26, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria1
- subjects aged between 5 and 75 years
Exclusion Criteria1
- Subjects unable to follow the study procedures or with any physical or mental condition deemed unsuitable by the doctor will be excluded from the study
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Interventions
A cheek support integrated into the mouthpiece is used for the measures
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06537362