Diagnosis of Respiratory Disorders by the Numerical Modeling.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Data collection.
- Who it may be relevant to
- Registry conditions: Nasal Obstruction, Deviated Nasal Septum. Basic parameters: 18 years — 69 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?
Overview
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
- Other Data collection
Retrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.
Primary outcome measures
- Correlation coefficient [Time frame: at inclusion (day 0)]
Secondary outcome measures (3)
- Physical values of air flow [Time frame: at inclusion (day 0)]
- flow parameters [Time frame: at inclusion (day 0)]
- weighting coefficients of the flow parameters [Time frame: at inclusion (day 0)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- CHU de Bordeaux — Bordeaux
Identifiers
NCT: NCT06670261 · CHUBX 2023/62