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| Name | Class |
|---|---|
| Seven Dreamers Europe SAS | INDUSTRY |
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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.
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Device : nasal airway stent | Experimental | All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device: nastent™ | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung Camille, MD | Contact | 01.57.02.22.68 | camille.jung@chicreteil.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Not yet recruiting | Créteil | 94000 | France |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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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 |
| Centre Hospitalier Intercommunal | Recruiting | Créteil | Île-de-France Region | 94000 | France |
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| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |