Clinical trial NCT06670261: Diagnosis of Respiratory Disorders by the Numerical Modeling.
Official title: JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nasal Obstruction
Deviated Nasal Septum
Keywords: Numerical modeling
Fluid Dynamics
Computer simulation
Septoplasty
Nasal Air Flow
Sinonasal CT-Scan
Computational Fluid Dynamic Simulation
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: CREATIS Laboratory
name: Optifluides
First posted: 2024-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: participant with or without chronic nasal obstruction seen in the rhinology department of Bordeaux University Hospital

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.

Eligibility 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.

Primary outcomes:
measure: Correlation coefficient
timeFrame: at inclusion (day 0)
Secondary outcomes:
measure: Physical values of air flow
timeFrame: at inclusion (day 0)
measure: flow parameters
timeFrame: at inclusion (day 0)
measure: weighting coefficients of the flow parameters
timeFrame: at inclusion (day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: