Efficacy of an Intranasal Stent on Nasal Obstruction at Night

Not Applicable

Recruiting

• Conditions: Nasal Obstruction

• Registration Number: NCT04228016
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

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 .

Study Timeline

• Study Start: 2019-09-27
• Study First Submitted: 2020-01-10
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-14
• Primary Completion: 2022-09-30
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-06
• Last Update Posted: 2023-03-07
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Epworth Sleepiness Scale (ESS)	Day 15	Scale \[0-24\] The higher the score, the more the quality of life is impaired.
Stent satisfaction	Day 15	Number of patients satisfied with the stent
Compliance	Day 15	Questionnaire on the use or non-use of the stent
Stent tolerance	Day 15	Questionnaire on stent tolerance or non-tolerance
Nasal Obstruction and Septoplasty Effectiveness (NOSE)	Day 15	Scale \[0-100\] The higher the score, the more the quality of life is impaired.
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

Trial Locations

Locations (2)

Centre Hospitalier Intercommunal; 🇫🇷 Créteil, Ile De France, France

Hôpital Henri Mondor; 🇫🇷 Créteil, France