Diagnosis of Respiratory Disorders by the Numerical Modeling. (JUNE)

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

Chronic Nasal obstruction (CNO) is not currently measurable objectively because clinicians use validated declarative self-questionnaires whose results are linked to the level of understanding, the acute or chronic clinical situation, fatigue, psychological state and the desired gain. Using numerical simulations of the passage of air in the nasal cavities determining specific airflow parameters, the respiratory comfort of healthy subjects and the CNO of patients treated for this pathology could be explained.

Study Overview

• Status: Recruiting
• Conditions: Nasal Obstruction; Deviated Nasal Septum
• Intervention / Treatment: Other: Data collection

Detailed Description

CNO concerns 20 to 25% of the general population due to numerous etiologies (septal deviation, polyps, chronic rhinosinusitis, post-therapeutic cancer quality of life…). It disrupts sleep and deteriorates all the compartments of the quality of life sometimes to depression. To date, nobody knows the exact component of CNO which is probably the amalgamation of different mucosal information and all measurement attempts have failed by lack of reliability and reproducibility. This major shortcoming of CNO quantification leads to diagnosis uncertainties, quantification of symptoms and therapeutic. The place of such complementary exam able to do an objective measure of NO is expected by the profession. The Computational Fluid Dynamic Simulation (CDFS) of the air passage would allow a complementary functional analysis to anatomy of the sino-nasal cavities to measure CNO. Such information would reduce the failure rate and unnecessary functional surgeries by 25%, reduce the inappropriate care of patients suffering to obstructive sleep disorders and reduce the financial burden on the health system. No patient follow-up in this study: pseudo-anonymized retrospective clinical and scannographic data from the routine management of patients in rhinosinusology consultations.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Ludovic De GABORY, Pr; Phone Number: +33 05 56 79 87 88; Email: ludovic.de-gabory@chu-bordeaux.fr
• Study Contact Backup: Name: Elodie BELMO; Phone Number: +33 (0) 557 102 895; Email: elodie.seris@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux
    • Principal Investigator: Ludovic De GABORY, Pr
    • Contact: Ludovic De GABORY, Pr; Phone Number: +33 05 56 79 87 88; Email: ludovic.de-gabory@chu-bordeaux.fr
    • Contact: Elodie BELMO; Phone Number: +33 557 102 895; Email: elodie.seris@chu-bordeaux.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

participant with or without chronic nasal obstruction seen in the rhinology department of Bordeaux University Hospital

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy subjects; 100 patients without ONC	Other: Data collection; Retrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.
Patients with CNO; 200 patients with anatomical ONC	Other: Data collection; Retrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation coefficient	Correlation coefficient of at least one of the simulation parameters greater than 0.5 with the NOSE score in a healthy population and a pathological population. This parameter could be Pressure (P), Temperature (T), mass exchanges (C) and/or shear stresses (SS).	at inclusion (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical values of air flow	Physical values of air flow in the normal population and in the pathological population suffering from ONC, during resting breathing for all CFD parameters at 0.5 sec from the start of the respiratory cycle.	at inclusion (day 0)
flow parameters	Statistical comparison of the flow parameters between these two groups and correlation of clinical data with the flow parameters.	at inclusion (day 0)
weighting coefficients of the flow parameters	Search for the weighting coefficients of the flow parameters and validation of the equation determining the CNO.	at inclusion (day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: CREATIS Laboratory; Optifluides

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 9, 2026

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): November 1, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 18, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Fluid Dynamics; Septoplasty; Computer simulation; Numerical modeling; Nasal Air Flow; Sinonasal CT-Scan; Computational Fluid Dynamic Simulation
• Additional Relevant MeSH Terms: Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Respiratory Tract Diseases; Respiration Disorders; Nasal Obstruction
• Other Study ID Numbers: CHUBX 2023/62

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No