Efficacy of an Intranasal Stent on Nasal Obstruction at Night (RHINASTENT)

Centre Hospitalier Intercommunal Creteil

Status: Enrolling

Conditions: Nasal Obstruction

Treatments: Device: Device: nastent™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04228016

RHINASTENT

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

46 participants in 1 patient group

Experimental: Device : nasal airway stent

Experimental group

Description:

All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus.

Treatment:

Device: Device: nastent™