Diagnosis of Respiratory Disorders by the Numerical Modeling.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-69
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Acute or chronic rhinosinusitis with or without polyps (except controlled allergic rhinitis)
Vasculitis
Empty nasal cavity syndrome
Septal perforations
Trial population
participant with or without chronic nasal obstruction seen in the rhinology department of Bordeaux University Hospital
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Data collection
Other interventionRetrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Healthy subjects1 intervention
Group B: Patients with CNO1 intervention
Trial outcomes
Primary outcomes
1
Correlation coefficient
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)Secondary outcomes
1
Physical values of air flow
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)2
flow parameters
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)3
weighting coefficients of the flow parameters
Search for the weighting coefficients of the flow parameters and validation of the equation determining the CNO.
Time frame
at inclusion (day 0)Sponsors and contacts
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Source ClinicalTrials.gov