Efficacy of an Intranasal Stent on Nasal Obstruction at Night
RHINASTENT
1 other identifier
interventional
46
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 27, 2019
CompletedFirst Submitted
Initial submission to the registry
January 10, 2020
CompletedFirst Posted
Study publicly available on registry
January 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedMarch 7, 2023
March 1, 2023
3 years
January 10, 2020
March 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Nasal Obstruction and Septoplasty Effectiveness (NOSE)
Day 15
Analog visual scale (EVA) of nocturnal nasal obstruction
Day 15
Sino-Nasal Outcome Test 22 (SNOT-22) questionary
Day 15
Epworth Sleepiness Scale (ESS)
Day 15
Compliance
Day 15
- +2 more secondary outcomes
Study Arms (1)
Experimental: Device : nasal airway stent
EXPERIMENTALAll patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Volontary patient
- Over 18 years old or more.
- Complain of a nasal obstruction more important (or only) at night (in decubitus position)
You may not qualify if:
- Unability to sign the consent form
- Allergy of stent component
- Perforation of nasal septum
- Haemostasis disorder or anticoagulant therapy
- Bilateral obstructive septal deviation ou polyposis induce inability to introduce the stent in the nasal cavities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Hôpital Henri Mondor
Créteil, 94000, France
Centre Hospitalier Intercommunal
Créteil, Île-de-France Region, 94000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2020
First Posted
January 14, 2020
Study Start
September 27, 2019
Primary Completion
September 30, 2022
Study Completion
September 30, 2023
Last Updated
March 7, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share