Efficacy of an Intranasal Stent on Nasal Obstruction at Night

Nasal Obstruction Clinical Trial

— RHINASTENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04228016
• Other study ID #: RHINASTENT
• Status: Recruiting
• Phase: N/A
• Start date: September 27, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: March 2023
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Jung Camille, MD
• Phone: 01.57.02.22.68
• Email: camille.jung[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal	Créteil	Ile De France
France	Hôpital Henri Mondor	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil	Seven Dreamers Europe SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Nasal Obstruction and Septoplasty Effectiveness (NOSE)	Scale [0-100] The higher the score, the more the quality of life is impaired.	Day 15
Secondary	Analog visual scale (EVA) of nocturnal nasal obstruction	Scale [0-10] The higher the score, the stronger the feeling of nasal obstruction.	Day 15
Secondary	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
Secondary	Epworth Sleepiness Scale (ESS)	Scale [0-24] The higher the score, the more the quality of life is impaired.	Day 15
Secondary	Compliance	Questionnaire on the use or non-use of the stent	Day 15
Secondary	Stent satisfaction	Number of patients satisfied with the stent	Day 15
Secondary	Stent tolerance	Questionnaire on stent tolerance or non-tolerance	Day 15