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

NCT06537362 | Recruiting

• 1 other identifier: CheekHolder
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiratory Morbidity; Lung Function Decreased

Keywords

Oscillometry

Outcome Measures

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

  within session (about 15 min)

Secondary Outcomes (3)

• evaluate patient's comfort during the measurement with the cheek support

  within session (about 15 min)

• face dimensions allowing for effective and comfortable cheek support

  within session (about 15 min)

• evaluate the type and frequency of measurement errors

  within session (about 15 min)

Study Arms (2)

Control

NO INTERVENTION

During oscillometry measures, the subject's cheeks are manually supported by an expert (Gold Standard method)

Cheek Holder

EXPERIMENTAL

During oscillometry measures, the subject's cheeks are supported by an integrated cheek support in the mouthpiece

Device: Mouthpiece with cheek-holder

Interventions

Mouthpiece with cheek-holder DEVICE

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

Cheek Holder

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Politecnico di Milano: lead

Study Sites (1)

Allergy and Pneumology Outpatient Clinic

Bergamo, Italy

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Raffale Dellaca, PhD

CONTACT

0223999005; raffaele.dellaca@polimi.it

Chiara Veneroni, PhD

CONTACT

0223999024; chiara.veneroni@polimi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 5, 2024
• Study Start: March 26, 2024
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 28, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)