Mouthpiece With Integrated Cheek Support vs. Manual Cheek Support During Respiratory Oscillometry
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-75
SponsorPolitecnico di Milano
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
subjects aged between 5 and 75 years
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Mouthpiece with cheek-holder
DeviceA cheek support integrated into the mouthpiece is used for the measures
Treatment groups
55 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Cheek HolderExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
impedance measurements
Compare the respiratory respiratory resistance (cmH2O\*s/L) and reactance (cmH2O\*s/L) at 5 Hz under the two measurement conditions
Time frame
within session (about 15 min)Secondary outcomes
1
evaluate patient's comfort during the measurement with the cheek support
evaluate the patient's comfort during the measurement with the cheek support and compare this comfort to the gold standard condition as quantified by the questionnaire
Time frame
within session (about 15 min)2
face dimensions allowing for effective and comfortable cheek support
assess the maximum and minimum face dimensions (to lip length and bigonial width) of the recruited subjects that allow for effective and comfortable cheek support as detailed in the Data Analysis section
Time frame
within session (about 15 min)3
evaluate the type and frequency of measurement errors
evaluate the type and frequency of measurement errors introduced by the use of the integrated cheek support in the mouthpiece.
Time frame
within session (about 15 min)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov