Nasal Obstruction
Conditions
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 .
Interventions
DEVICEDevice: nastent™
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.
Sponsors
Seven Dreamers Europe SAS
Centre Hospitalier Intercommunal Creteil
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Volontary patient 2. Over 18 years old or more. 3. Complain of a nasal obstruction more important (or only) at night (in decubitus position)
Exclusion criteria
1. Unability to sign the consent form 2. Allergy of stent component 3. Perforation of nasal septum 4. Haemostasis disorder or anticoagulant therapy 5. Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nasal resistance in anterior rhinomanometry (sPa/ml/sec) | Day 15 | Change grom Baseline of Nasal resistance in anterior rhinomanometry. Sitting, lying in the meadow and Per stent nasal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analog visual scale (EVA) of nocturnal nasal obstruction | Day 15 | Scale \[0-10\] The higher the score, the stronger the feeling of nasal obstruction. |
| Sino-Nasal Outcome Test 22 (SNOT-22) questionary | Day 15 | Scale \[0-100\]. The total score can range from 0 to 110, with values increasing as the severity of symptoms worsens |
| Epworth Sleepiness Scale (ESS) | Day 15 | Scale \[0-24\] The higher the score, the more the quality of life is impaired. |
| Nasal Obstruction and Septoplasty Effectiveness (NOSE) | Day 15 | Scale \[0-100\] The higher the score, the more the quality of life is impaired. |
| Stent satisfaction | Day 15 | Number of patients satisfied with the stent |
| Stent tolerance | Day 15 | Questionnaire on stent tolerance or non-tolerance |
| Compliance | Day 15 | Questionnaire on the use or non-use of the stent |
Countries
France
Contacts
Primary ContactJung Camille, MD
Outcome results
None listed