Nasal ObstructionJUNENCT06670261
Diagnosis of Respiratory Disorders by the Numerical Modeling.
An observational study of Nasal Obstruction and Deviated Nasal Septum, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction, Deviated Nasal Septum
- What is being tested?
- Data collection
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2024to 9 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participant with or without chronic nasal obstruction seen in the rhinology department of Bordeaux University Hospital
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Ludovic De GABORY, Pr, 05 56 79 87 88 ext. +33, ludovic.de-gabory@chu-bordeaux.fr
Elodie BELMO, 557 102 895 ext. +33, elodie.seris@chu-bordeaux.fr
About this study
Official title: JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?
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.
Read the 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.
- Conditions
- Nasal Obstruction, Deviated Nasal Septum
- Being tested
- Data collection
- Keywords
- Numerical modeling, Fluid Dynamics, Computer simulation, Septoplasty, Nasal Air Flow, Sinonasal CT-Scan, Computational Fluid Dynamic Simulation
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Retrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | 100 patients without ONC Receives: Other: Data collection | |
| Patients with CNO | 200 patients with anatomical ONC Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at inclusion (day 0)
Secondary outcomes (3)
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.
Measured: at inclusion (day 0)
flow parameters
Statistical comparison of the flow parameters between these two groups and correlation of clinical data with the flow parameters.
Measured: at inclusion (day 0)
weighting coefficients of the flow parameters
Search for the weighting coefficients of the flow parameters and validation of the equation determining the CNO.
Measured: at inclusion (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start9 Jul 2024
- Primary completion9 Jul 2026 (estimated)
- Study completion9 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- CREATIS Laboratory, Optifluides
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670261
- Sponsor's protocol ID
- CHUBX 2023/62
- Acronym
- JUNE
- Status last verified
- Apr 2025
- First submitted
- 30 Oct 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JUNE Project: Does the Modeling of Nasal Airflows Improve the Pathophysiological Understanding and the Diagnosis of Functional Respiratory Disorders?
- ClinicalTrials.gov ID
- NCT06670261
- Acronym / sponsor ID
- JUNE / CHUBX 2023/62
- Conditions
- Nasal Obstruction, Deviated Nasal Septum
- Keywords
- Numerical modeling, Fluid Dynamics, Computer simulation, Septoplasty, Nasal Air Flow, Sinonasal CT-Scan, Computational Fluid Dynamic Simulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- CREATIS Laboratory, Optifluides
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 9 Jul 2026 (estimated)
- Study completion
- 9 Jul 2026 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | – | Other: Data collection100 patients without ONC |
| Patients with CNO | – | Other: Data collection200 patients with anatomical ONC |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participant with or without chronic nasal obstruction seen in the rhinology department of Bordeaux University Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionRetrospective pseudo-anonymized clinical and scannographic data from the routine management of patients in rhino-sinusology consultations. | Other | Healthy subjects, Patients with CNO |
Primary outcome
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).
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasal Obstruction and Deviated Nasal Septum, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ludovic De GABORY, Pr (05 56 79 87 88 ext. +33, ludovic.de-gabory@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation coefficient (time frame: at inclusion (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.