An observational study in Nasal Obstruction, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Observational
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:
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%.
173 studies on the registry are indexed under Nasal Obstruction; 31 are open to participants now.
This study's planned enrollment of 200 is above the median of 80 across 25 observational studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
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Patients presenting with nasal obstruction, scheduled for surgery, and having undergone preoperative rhinomanometry
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Exclusion Criteria:
Patients scheduled for surgery who underwent preoperative rhinomanometry
Procedure: preoperative rhinomanometry
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
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.
Time frame: the day of surgery
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).
Time frame: 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)
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
Difference between pre- and 3-month postoperative NOSE scores in patients with an abnormal preoperative AAR result
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
Difference between pre- and 3-month postoperative SNOT-22 scores in patients with an abnormal preoperative AAR result
Time frame: 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
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
Difference between pre- and 3-month postoperative apnea-hypopnea index (AHI) in patients with identified sleep apnea and an abnormal preoperative AAR result
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.
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.
Time frame: 3 months after surgery
Plan to share: No
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Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer