Efficacy of an Intranasal Stent on Nasal Obstruction at Night

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-27

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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 .

Conditions

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Nasal Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental: Device : nasal airway stent

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

Group Type EXPERIMENTAL

Device: nastent™

Intervention Type 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.

Interventions

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Device: 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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No