Efficacy of an Intranasal Stent on Nasal Obstruction at Night

Study Overview
=================
Brief Summary
-----------------
This study aims to demonstrate a decrease with normalization of nasal resistance in the forward decubital position and with an intra-nasal stent in patients with nasal obstruction.

Detailed Description
-----------------
All patients consulting for nasal obstruction at night and who have functional nasal test with pathological resistance in decubitus position are included. Functional nasal test (non invasive tests) will be performed before and after intranasal introduction of a stent: anterior rhinomanometry to measure nasal function by the measure of resistance and acoustic rhinometry to measure the geometry of nasal fossa by the measure of minimal sectional cross area sitting, after 30 minutes of decubitus then new measurements with a stent in decubitus position in each nostril .

Official Title
-----------------
Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study

Conditions
-----------------
Nasal Obstruction

Intervention / Treatment
-----------------
* Device: Device: nastent™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Volontary patient Over 18 years old or more. Complain of a nasal obstruction more important (or only) at night (in decubitus position) Exclusion Criteria: Unability to sign the consent form Allergy of stent component Perforation of nasal septum Haemostasis disorder or anticoagulant therapy Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Device : nasal airway stent<br>All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus. | Device: Device: nastent™<br>* Patients with Nasal obstruction at night, will be used intrasal stent during 15 nights. These are flexible silicone tubes that are lubricated and easy to insert into the nasal cavities, which would restore the permeability of the nasal cavities.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal resistance in anterior rhinomanometry (sPa/ml/sec) | Change grom Baseline of Nasal resistance in anterior rhinomanometry. Sitting, lying in the meadow and Per stent nasal. | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nasal Obstruction and Septoplasty Effectiveness (NOSE) | Scale [0-100] The higher the score, the more the quality of life is impaired. | Day 15 | 
| Analog visual scale (EVA) of nocturnal nasal obstruction | Scale [0-10] The higher the score, the stronger the feeling of nasal obstruction. | Day 15 | 
| Sino-Nasal Outcome Test 22 (SNOT-22) questionary | Scale [0-100]. The total score can range from 0 to 110, with values increasing as the severity of symptoms worsens | Day 15 | 
| Epworth Sleepiness Scale (ESS) | Scale [0-24] The higher the score, the more the quality of life is impaired. | Day 15 | 
| Compliance | Questionnaire on the use or non-use of the stent | Day 15 | 
| Stent satisfaction | Number of patients satisfied with the stent | Day 15 | 
| Stent tolerance | Questionnaire on stent tolerance or non-tolerance | Day 15 |