Nasal ObstructionRHINOVENCT07379775
Evaluation of the Reliability of AAR as an Independent Tool for Surgical Indication in Nasal Obstruction
An observational study of Nasal Obstruction, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in France.
Trial summary
Nasal obstruction (NO) affects ~30% of the population and is a very common reason for consultation in otorhinolaryngology (ORL). In the majority of cases, the origin is inflammatory (allergic rhinitis and chronic rhinosinusitis) while in a minority of cases, the origin is structural, including septal deviation and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- preoperative rhinomanometry
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2026to Mar 2028
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting with nasal obstruction, scheduled for surgery, and having undergone preoperative rhinomanometry
Who may be able to join
- Patients aged 18 years or older with nasal obstruction (NO).
- Patients scheduled for surgery: septoplasty ± turbinoplasty ± rhinoplasty for nasal obstruction.
- Patients who have undergone a preoperative rhinomanometry assessment.
- Patients consented to participation
Who cannot join
- Nasal polyps.
- Chronic edematous-purulent rhinosinusitis (e.g., cystic fibrosis).
- Crusting rhinosinusitis (e.g., sarcoidosis, granulomatosis with polyangiitis [Wegener's]).
- Current or previously treated nasal or sinus tumors, or patients undergoing tumor work-up
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
Centre Hospitalier de la Dracénie
Draguignan, Var, 83007
Heritsilavo Eloi RAMILISON, MD, 0494605869 ext. +33, heritsilavo.ramilison@ch-draguignan.fr
Charly BESSADIER, MD, 0494605869 ext. +33, charly.bessadier@ch-draguignan.fr
About this study
Official title: Evaluation of the Reliability of Anterior Active Rhinomanometry as an Independent Tool for Surgical Indication in Nasal Obstruction
Nasal obstruction (NO) affects ~30% of the population and is a very common reason for consultation in otorhinolaryngology (ORL). In the majority of cases, the origin is inflammatory (allergic rhinitis and chronic rhinosinusitis) while in a minority of cases, the origin is structural, including septal deviation and inferior turbinate hypertrophy.
NO significantly impairs patients' quality of life (QoL) and olfactory performance and also represents a contributing factor and comorbidity in asthma and obstructive sleep apnea syndrome. Several questionnaires for assessing QoL are available and routinely used to evaluate the impact of NO on patients : VAS, NOSE score, SNOT-22, and RhinoQOL score.
Read more
Several objective functional methods for assessing NO have been described : acoustic rhinometry, nasal peak inspiratory flow, and active rhinomanometry. Rhinomanometry is a simple, non-invasive functional assessment method that allows for objective and quantitative analysis of nasal airway patency, thereby complementing the clinical and imaging evaluation of NO.
It has been recommended for the diagnosis of NO in cases of chronic rhinitis and chronic rhinosinusitis with nasal polyposis. Rhinomanometry comprises anterior active (AAR), posterior, and per-nasal rhinomanometry. AAR is the most commonly used method and is the only technique routinely available to clinicians. AAR provides precise information regarding the presence of nasal resistance responsible for NO. However, it should not be used as a standalone diagnostic tool due to its poor correlation with QoL questionnaires such as VAS and NOSE.
Whether used alone or in combination with nasal decongestants, AAR provides a high predictive value for the outcomes of septoplasty and laser-assisted turbinoplasty.
When surgery is indicated, its performance depends on:
- type of obstruction or anatomical abnormality identified on clinical examination and/or computed tomography and/or AAR;
- patient's symptoms and impairment of QoL NOSE and SNOT-22;
- failure of a well-conducted first-line medical nasal treatment. Thus, in cases of septal deviation, septoplasty is performed; in cases of inferior turbinate mucosal hypertrophy with failure of medical treatment, turbinoplasty is performed; and in cases of mixed lesions, septo-turbinoplasty is performed.
However, the concordance rate between the surgical technique indicated by clinical examination and computed tomography and the indications suggested by AAR is only 48.5%.
- Conditions
- Nasal Obstruction
- Being tested
- preoperative rhinomanometry
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative rhinomanometryProcedure or surgery
The performance of AAR requires a pressure sensor placed within a facial mask to measure the pressure at the entrance of the ventilated nasal cavity. Another sensor is placed in the nasal vestibule of the contralateral nasal cavity to extrapolate the pressure at the exit of the ventilated nasal cavity. Measurements are therefore performed alternately on the right and left sides, but never on both sides simultaneously.
AAR can be performed at rest in the seated position after 20 min in the supine position, or during forced inspiration.
In our practice, AAR is performed without the use of nasal decongestants.
Normal values of nasal resistance measured by rhinomanometry are as follows:
- Uninasal resistance ≤ 6 cmH₂O/L/s (or 0.6 Pa/cm³/s);
- Binasal resistance ≤ 3 cmH₂O/L/s (or 0.3 Pa/cm³/s);
- Uninasal resistance ≥ 0.6 Pa/cm³/s, with or without vasoconstrictor, suggests septal deviation;
- Binasal resistance after VC ≥ 0.3 Pa/cm³/s suggests bilateral inferior turbinate hypertrophy
| Study group | Role | What they receive |
|---|---|---|
| Patients with nasal obstruction | Patients scheduled for surgery who underwent preoperative rhinomanometry Receives: Procedure: preoperative rhinomanometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the reliability of an abnormal (vs. normal) binary result of preoperative anterior active rhinomanometry as an independent tool for confirming the indication for endonasal surgery in patients presenting with nasal obstruction.
The result was considered normal if: Uninasal resistance ≤ 6 cmH₂O/L/s (or 0.6 Pa/cm³/s); Binasal resistance ≤ 3 cmH₂O/L/s (or 0.3 Pa/cm³/s). The criteria is 1) Percentage of patients with an abnormal versus normal preoperative AAR result; and 2) calculation of the positive and negative predictive values (PPV and NPV) of AAR as an independent tool for confirming surgical indication.
Measured: the day of surgery
Secondary outcomes (7)
To evaluate the correlation between the preoperative NOSE score and a preoperative AAR considered abnormal.
Correlation coefficient between the preoperative NOSE score and the preoperative AAR result (normal/abnormal).
Measured: preoperative visit
To evaluate the correlation between the preoperative SNOT-22 score and a preoperative AAR considered abnormal.
Correlation coefficient between the preoperative SNOT-22 score and the preoperative AAR result (normal/abnormal)
Measured: preoperative visit
To assess the improvement in patients' quality of life at 3 months postoperatively using the NOSE score in patients with a preoperative AAR considered abnormal
Difference between pre- and 3-month postoperative NOSE scores in patients with an abnormal preoperative AAR result
Measured: 3 months after surgery
To assess the improvement in patients' quality of life at 3 months postoperatively using the SNOT-22 score in patients with a preoperative AAR considered abnormal
Difference between pre- and 3-month postoperative SNOT-22 scores in patients with an abnormal preoperative AAR result
Measured: 3 months after surgery
To assess the improvement in AAR at 3 months postoperatively in patients with a preoperative AAR considered abnormal
Percentage of AAR results significantly improved at 3 months postoperatively in patients with an abnormal preoperative AAR
Measured: 3 months after surgery
To assess the improvement in the apnea-hypopnea index (AHI) at 3 months postoperatively in patients with identified obstructive sleep apnea and a preoperative AAR considered abnormal
Difference between pre- and 3-month postoperative apnea-hypopnea index (AHI) in patients with identified sleep apnea and an abnormal preoperative AAR result
Measured: 3 months after surgery
To assess the improvement in continuous positive airway pressure (CPAP) adherence at 3 months postoperatively in patients with identified obstructive sleep apnea and a preoperative AAR considered abnormal.
Difference between pre- and 3-month postoperative adherence to continuous positive airway pressure (CPAP) in patients with identified sleep apnea and an abnormal preoperative AAR result.
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start27 Jan 2026
- Primary completionJan 2028 (estimated)
- Study completionMar 2028 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heritsilavo Eloi RAMILISON, MD, Study director, Centre Hospitalier de la Dracénie - Draguignan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07379775
- Sponsor's protocol ID
- 2025-CHITS-018
- Acronym
- RHINOVE
- Status last verified
- Jul 2026
- First submitted
- 23 Jan 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Reliability of Anterior Active Rhinomanometry as an Independent Tool for Surgical Indication in Nasal Obstruction
- ClinicalTrials.gov ID
- NCT07379775
- Acronym / sponsor ID
- RHINOVE / 2025-CHITS-018
- Conditions
- Nasal Obstruction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 30 Jan 2026 (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.
Nasal obstruction (NO) affects ~30% of the population and is a very common reason for consultation in otorhinolaryngology (ORL). In the majority of cases, the origin is inflammatory (allergic rhinitis and chronic rhinosinusitis) while in a minority of cases, the origin is structural, including septal deviation and inferior turbinate hypertrophy.
NO significantly impairs patients' quality of life (QoL) and olfactory performance and also represents a contributing factor and comorbidity in asthma and obstructive sleep apnea syndrome. Several questionnaires for assessing QoL are available and routinely used to evaluate the impact of NO on patients : VAS, NOSE score, SNOT-22, and RhinoQOL score.
Several objective functional methods for assessing NO have been described : acoustic rhinometry, nasal peak inspiratory flow, and active rhinomanometry. Rhinomanometry is a simple, non-invasive functional assessment method that allows for objective and quantitative analysis of nasal airway patency, thereby complementing the clinical and imaging evaluation of NO.
It has been recommended for the diagnosis of NO in cases of chronic rhinitis and chronic rhinosinusitis with nasal polyposis. Rhinomanometry comprises anterior active (AAR), posterior, and per-nasal rhinomanometry. AAR is the most commonly used method and is the only technique routinely available to clinicians. AAR provides precise information regarding the presence of nasal resistance responsible for NO. However, it should not be used as a standalone diagnostic tool due to its poor correlation with QoL questionnaires such as VAS and NOSE.
Whether used alone or in combination with nasal decongestants, AAR provides a high predictive value for the outcomes of septoplasty and laser-assisted turbinoplasty.
When surgery is indicated, its performance depends on:
- type of obstruction or anatomical abnormality identified on clinical examination and/or computed tomography and/or AAR;
- patient's symptoms and impairment of QoL NOSE and SNOT-22;
- failure of a well-conducted first-line medical nasal treatment. Thus, in cases of septal deviation, septoplasty is performed; in cases of inferior turbinate mucosal hypertrophy with failure of medical treatment, turbinoplasty is performed; and in cases of mixed lesions, septo-turbinoplasty is performed.
However, the concordance rate between the surgical technique indicated by clinical examination and computed tomography and the indications suggested by AAR is only 48.5%.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with nasal obstruction | – | Procedure: preoperative rhinomanometryPatients scheduled for surgery who underwent preoperative rhinomanometry |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting with nasal obstruction, scheduled for surgery, and having undergone preoperative rhinomanometry
Key inclusion criteria (4 listed)
- Patients aged 18 years or older with nasal obstruction (NO).
- Patients scheduled for surgery: septoplasty ± turbinoplasty ± rhinoplasty for nasal obstruction.
- Patients who have undergone a preoperative rhinomanometry assessment.
- Patients consented to participation
Key exclusion criteria (4 listed)
- Nasal polyps.
- Chronic edematous-purulent rhinosinusitis (e.g., cystic fibrosis).
- Crusting rhinosinusitis (e.g., sarcoidosis, granulomatosis with polyangiitis [Wegener's]).
- Current or previously treated nasal or sinus tumors, or patients undergoing tumor work-up
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 |
|---|---|---|
| preoperative rhinomanometryThe performance of AAR requires a pressure sensor placed within a facial mask to measure the pressure at the entrance of the ventilated nasal cavity. Another sensor is placed in the nasal vestibule of the contralateral nasal cavity to extrapolate the pressure at the exit of the ventilated nasal cavity. Measurements are therefore performed alternately on the right and left sides, but never on both sides simultaneously. AAR can be performed at rest in the seated position after 20 min in the supine position, or during forced inspiration. In our practice, AAR is performed without the use of nasal decongestants. Normal values of nasal resistance measured by rhinomanometry are as follows: * Uninasal resistance ≤ 6 cmH₂O/L/s (or 0.6 Pa/cm³/s); * Binasal resistance ≤ 3 cmH₂O/L/s (or 0.3 Pa/cm³/s); * Uninasal resistance ≥ 0.6 Pa/cm³/s, with or without vasoconstrictor, suggests septal deviation; * Binasal resistance after VC ≥ 0.3 Pa/cm³/s suggests bilateral inferior turbinate hypertrophy | Procedure or surgery | Patients with nasal obstruction |
Primary outcome
To evaluate the reliability of an abnormal (vs. normal) binary result of preoperative anterior active rhinomanometry as an independent tool for confirming the indication for endonasal surgery in patients presenting with nasal obstruction.
Time frame: the day of surgery
The result was considered normal if: Uninasal resistance ≤ 6 cmH₂O/L/s (or 0.6 Pa/cm³/s); Binasal resistance ≤ 3 cmH₂O/L/s (or 0.3 Pa/cm³/s). The criteria is 1) Percentage of patients with an abnormal versus normal preoperative AAR result; and 2) calculation of the positive and negative predictive values (PPV and NPV) of AAR as an independent tool for confirming surgical indication.
7 secondary outcomes
To evaluate the correlation between the preoperative NOSE score and a preoperative AAR considered abnormal.
Time frame: preoperative visit
To evaluate the correlation between the preoperative SNOT-22 score and a preoperative AAR considered abnormal.
Time frame: preoperative visit
To assess the improvement in patients' quality of life at 3 months postoperatively using the NOSE score in patients with a preoperative AAR considered abnormal
Time frame: 3 months after surgery
To assess the improvement in patients' quality of life at 3 months postoperatively using the SNOT-22 score in patients with a preoperative AAR considered abnormal
Time frame: 3 months after surgery
To assess the improvement in AAR at 3 months postoperatively in patients with a preoperative AAR considered abnormal
Time frame: 3 months after surgery
To assess the improvement in the apnea-hypopnea index (AHI) at 3 months postoperatively in patients with identified obstructive sleep apnea and a preoperative AAR considered abnormal
Time frame: 3 months after surgery
To assess the improvement in continuous positive airway pressure (CPAP) adherence at 3 months postoperatively in patients with identified obstructive sleep apnea and a preoperative AAR considered abnormal.
Time frame: 3 months after surgery
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Heritsilavo Eloi RAMILISON, MD study director
Centre Hospitalier de la Dracénie - Draguignan
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, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer 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 4 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 7 Jul 2026. 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 Sophie Lafond (0483772062 ext. +33, sophie.lafond@ch-toulon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the reliability of an abnormal (vs. normal) binary result of preoperative anterior active rhinomanometry as an independent tool for confirming the indication for endonasal surgery in patients presenting with nasal obstruction. (time frame: the day of surgery). 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 7 Jul 2026.