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NCT Number: NCT06670261

Diagnosis of Respiratory Disorders by the Numerical Modeling.

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.

Recruiting

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Key information

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. Correlation coefficient

    Time frame: at 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 outcomes

  1. Physical values of air flow

    Time frame: at 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.

  2. flow parameters

    Time frame: at inclusion (day 0)

    Statistical comparison of the flow parameters between these two groups and correlation of clinical data with the flow parameters.

  3. weighting coefficients of the flow parameters

    Time frame: at inclusion (day 0)

    Search for the weighting coefficients of the flow parameters and validation of the equation determining the CNO.

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie BELMO

CONTACT

[email protected]

(0) 557 102 895 ext. +33

Ludovic De GABORY, Pr

CONTACT

[email protected]

05 56 79 87 88 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • CREATIS Laboratory
  • Optifluides

Registry information

Official study title

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

Acronym: JUNE

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 1, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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