RecruitingNot ApplicableNCT06537362

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


Sponsor

Politecnico di Milano

Enrollment

55 participants

Start Date

Mar 26, 2024

Study Type

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

Min Age: 5 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Mouthpiece with cheek-holder for people with lung function decreased and respiratory morbidity. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMouthpiece with cheek-holder

A cheek support integrated into the mouthpiece is used for the measures


Locations(1)

Allergy and Pneumology Outpatient Clinic

Bergamo, Italy

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NCT06537362


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