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Diagnosis of Respiratory Disorders by the Numerical Modeling.

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06670261
Acronym
JUNE
Enrollment
300
Registered
2024-11-01
Start date
2024-07-09
Completion date
2026-07-09
Last updated
2025-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deviated Nasal Septum, Nasal Obstruction

Keywords

Numerical modeling, Fluid Dynamics, Computer simulation, Septoplasty, Nasal Air Flow, Sinonasal CT-Scan, Computational Fluid Dynamic Simulation

Brief summary

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.

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.

Interventions

OTHERData collection

Retrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.

Sponsors

CREATIS Laboratory
CollaboratorUNKNOWN
Optifluides
CollaboratorUNKNOWN
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Correlation coefficientat inclusion (day 0)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).

Secondary

MeasureTime frameDescription
Physical values of air flowat inclusion (day 0)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.
flow parametersat inclusion (day 0)Statistical comparison of the flow parameters between these two groups and correlation of clinical data with the flow parameters.
weighting coefficients of the flow parametersat inclusion (day 0)Search for the weighting coefficients of the flow parameters and validation of the equation determining the CNO.

Countries

France

Contacts

Primary ContactLudovic De GABORY, Pr
ludovic.de-gabory@chu-bordeaux.fr05 56 79 87 88
Backup ContactElodie BELMO
elodie.seris@chu-bordeaux.fr(0) 557 102 895

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026