Diagnosis of Respiratory Disorders by the Numerical Modeling.

NCT06670261 | Recruiting

• 1 other identifier: CHUBX 2023/62
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Obstruction; Deviated Nasal Septum

Keywords

Numerical modeling; Fluid Dynamics; Computer simulation; Septoplasty; Nasal Air Flow; Sinonasal CT-Scan; Computational Fluid Dynamic Simulation

Outcome Measures

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).

  at inclusion (day 0)

Secondary Outcomes (3)

• Physical values of air flow

  at inclusion (day 0)

• flow parameters

  at inclusion (day 0)

• weighting coefficients of the flow parameters

  at inclusion (day 0)

Study Arms (2)

Healthy subjects

100 patients without ONC

Other: Data collection

Patients with CNO

200 patients with anatomical ONC

Other: Data collection

Interventions

Data collection OTHER

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

Healthy subjects; Patients with CNO

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

participant with or without chronic nasal obstruction seen in the rhinology department of Bordeaux University Hospital

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• CREATIS Laboratory: collaborator
• Optifluides: collaborator

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Nasal Obstruction

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Ludovic De GABORY, Pr

CONTACT

05 56 79 87 88; ludovic.de-gabory@chu-bordeaux.fr

Elodie BELMO

CONTACT

(0) 557 102 895; elodie.seris@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 1, 2024
• Study Start: July 9, 2024
• Primary Completion (Estimated): July 9, 2026
• Study Completion (Estimated): July 9, 2026
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

FR (1)