Actively Recruiting
Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry
Led by Politecnico di Milano · Updated on 2024-08-28
55
Participants Needed
1
Research Sites
18 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged between 5 and 75 years
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Allergy and Pneumology Outpatient Clinic
Bergamo, Italy
Actively Recruiting
Research Team
R
Raffale Dellaca, PhD
CONTACT
C
Chiara Veneroni, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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