Actively Recruiting

Age: 18Years - 69Years
All Genders
Healthy Volunteers
ID06670261

JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?

Led by University Hospital, Bordeaux · Updated on 2025-04-24

300

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University Hospital, Bordeaux

Lead Sponsor

C

CREATIS Laboratory

Collaborating Sponsor

AI-Summary

What this Trial Is About

Chronic Nasal Obstruction (CNO) affects 20 to 25% of people and has many causes such as septal deviation, polyps, chronic rhinosinusitis, and post-therapeutic cancer effects. It can disrupt sleep and lower quality of life, sometimes leading to depression. Current diagnosis relies on self-reported questionnaires, which can be influenced by many factors and lack objective measurement, causing uncertainties in diagnosis and treatment. Researchers are evaluating the use of Computational Fluid Dynamic Simulation (CDFS) to model air passage in the nasal cavities. This method aims to provide a functional analysis that complements anatomical studies by measuring airflow parameters associated with nasal obstruction. The study uses retrospective, pseudo-anonymized clinical and scan data from routine rhinosinusology consultations, including 100 patients without obstruction and 200 patients with anatomical obstruction. Participants' data will be analyzed to find correlations and physical airflow values related to their nasal condition. Researchers will assess flow parameters and their weighting coefficients at the time of inclusion. There is no patient follow-up in this study. The goal is to improve the understanding and diagnosis of nasal airflow disorders, potentially reducing unnecessary surgeries and healthcare costs. The study runs from July 2024 to July 2026, involving adults aged 18 to 69 years.

CONDITIONS

Brief Title

Diagnosis of Respiratory Disorders by the Numerical Modeling.

Who Can Participate

Age: 18Years - 69Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and less than 70 years
  • Body mass index (BMI) less than 30 kg/m2
  • Subject or patient of Caucasian ethnic origin or from the Mediterranean region
  • Asymptomatic subjects with or without septal deviation and NOSE score 7 or less
  • Patients with chronic nasal obstruction due to morphological causes with NOSE score 9 or higher, with or without sleep apnea and Apnea-Hypopnea Index 20 or less
Not Eligible

You will not qualify if you...

  • Acute or chronic rhinosinusitis with or without polyps (except controlled allergic rhinitis)
  • Vasculitis
  • Empty nasal cavity syndrome
  • Septal perforations
  • History of nasal plastic surgery, sinonasal endoscopic surgery, or head/neck cancer with radiotherapy
  • Uncontrolled bronchopulmonary diseases
  • Treatments affecting nasal vasomotor function

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion (day 0)

Participants undergo retrospective pseudo-anonymized clinical and scannographic data collection from their routine rhinosinusology consultations to assess nasal airflow and respiratory function.

1 visit (data collection from routine care)

Trial Site Locations

Total: 1 location

1

CHU de Bordeaux

Bordeaux, France

Actively Recruiting

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Research Team

L

Ludovic De GABORY, Pr

E

Elodie BELMO

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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