CHU de Bordeaux
Bordeaux, France
Location status: Recruiting
Location contact
Elodie BELMO
CONTACT
557 102 895 ext. +33
Ludovic De GABORY, Pr
CONTACT
05 56 79 87 88 ext. +33
Ludovic De GABORY, Pr
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06670261
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.
Interested in participating?
Request Info18 year–69 year
All sexes
Observational
Bordeaux, France
Location status: Recruiting
Elodie BELMO
CONTACT
557 102 895 ext. +33
Ludovic De GABORY, Pr
CONTACT
05 56 79 87 88 ext. +33
Ludovic De GABORY, Pr
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Retrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.
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).
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.
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.
Time frame: at inclusion (day 0)
Search for the weighting coefficients of the flow parameters and validation of the equation determining the CNO.
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?
Acronym: JUNE
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.
Published trials that share one or more normalized conditions with this study.
NCT07379775
Airway Obstruction, Nasal Obstruction
Draguignan, Var, France
View Trial DetailsNCT07531810
Airway Obstruction, Nasal Deformity
Sivas, Turkey (Türkiye)
View Trial DetailsNCT07626437
Airway Obstruction, Common Cold
Belo Horizonte, Minas Gerais, Brazil
View Trial DetailsNCT05920330
Airway Obstruction, Nasal Obstruction
Columbus, Ohio, United States
View Trial Details