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

Recruiting now · Not applicable

Conditions studied: Respiratory Morbidity, Lung Function Decreased

In brief

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.

Key facts

Study ID

NCT06537362

Run by

Politecnico di Milano

People needed

55

Starts

2024-03-26

Expected to finish

2024-08-01

Last updated by the study team

2024-08-28

Who can join

Age: 5 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• subjects aged between 5 and 75 years

You may not qualify if…

• 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

Where it is running

• Allergy and Pneumology Outpatient Clinic — Bergamo, Italy (enrolling)

Full record on ClinicalTrials.gov

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