Using numerical modeling to diagnose respiratory disorders
JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?
University Hospital, Bordeaux · NCT06670261
This study is testing a new way to measure breathing problems caused by nasal blockages to help people with these issues get better diagnoses and avoid unnecessary surgeries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT06670261 on ClinicalTrials.gov |
What this trial studies
This observational study aims to objectively measure chronic nasal obstruction (CNO) using computational fluid dynamics simulations to analyze airflow in the nasal cavities. By collecting retrospective clinical and scannographic data, the study seeks to identify specific airflow parameters that correlate with respiratory comfort in both healthy individuals and patients with CNO. The goal is to improve diagnostic accuracy and reduce unnecessary surgeries by providing a reliable measurement of nasal obstruction. The study focuses on patients with nasal obstruction due to septal deviation and other morphological issues.
Who should consider this trial
Good fit: Ideal candidates include Caucasian individuals aged 18 to 70 with either symptomatic nasal obstruction requiring surgery or asymptomatic individuals with septal deviation.
Not a fit: Patients with acute or chronic rhinosinusitis, nasal surgery history, or other significant nasal pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate diagnoses and better treatment outcomes for patients suffering from chronic nasal obstruction.
How similar studies have performed: While the use of computational fluid dynamics in nasal airflow analysis is a novel approach, similar studies have shown promise in improving diagnostic accuracy for respiratory conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years ≤ age \< 70 years * BMI \< 30 kg/m2 * Subject or Patient of Caucasian ethnic origin or from the Mediterranean region. * Asymptomatic subject with or without a septal deviation without sinonasal disease with a NOSE score ≤ 7 Or Patient suffering from chronic nasal obstruction of morphological origin (symptomatic septal or nasoseptal deviation) requiring surgical management with a NOSE score ≥ 9/20, without or .with sleep apnea with an Apnea-hypopnea index ≤ 20 with no other cause than this apnea syndrome Exclusion Criteria: * 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 and cancer with head or neck radiotherapy * Uncontrolled bronchopulmonary pathology * Treatments with nasal vasomotor repercussions.
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (RECRUITING)
Study contacts
- Study coordinator: Ludovic De GABORY, Pr
- Email: ludovic.de-gabory@chu-bordeaux.fr
- Phone: 05 56 79 87 88
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Nasal Obstruction, Deviated Nasal Septum, Numerical modeling, Fluid Dynamics, Computer simulation, Septoplasty, Nasal Air Flow, Sinonasal CT-Scan