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

Primary Purpose

Nasal Obstruction

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Device: nastent™
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nasal Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Centre Hospitalier IntercommunalRecruiting
  • Hôpital Henri Mondor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Device : nasal airway stent

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
January 10, 2020
Last Updated
March 6, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Seven Dreamers Europe SAS
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1. Study Identification

Unique Protocol Identification Number
NCT04228016
Brief Title
Efficacy of an Intranasal Stent on Nasal Obstruction at Night
Acronym
RHINASTENT
Official Title
Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 27, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Seven Dreamers Europe SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Device : nasal airway stent
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Device: nastent™
Intervention Description
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.
Primary Outcome Measure Information:
Title
Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
Description
Change grom Baseline of Nasal resistance in anterior rhinomanometry. Sitting, lying in the meadow and Per stent nasal.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Nasal Obstruction and Septoplasty Effectiveness (NOSE)
Description
Scale [0-100] The higher the score, the more the quality of life is impaired.
Time Frame
Day 15
Title
Analog visual scale (EVA) of nocturnal nasal obstruction
Description
Scale [0-10] The higher the score, the stronger the feeling of nasal obstruction.
Time Frame
Day 15
Title
Sino-Nasal Outcome Test 22 (SNOT-22) questionary
Description
Scale [0-100]. The total score can range from 0 to 110, with values increasing as the severity of symptoms worsens
Time Frame
Day 15
Title
Epworth Sleepiness Scale (ESS)
Description
Scale [0-24] The higher the score, the more the quality of life is impaired.
Time Frame
Day 15
Title
Compliance
Description
Questionnaire on the use or non-use of the stent
Time Frame
Day 15
Title
Stent satisfaction
Description
Number of patients satisfied with the stent
Time Frame
Day 15
Title
Stent tolerance
Description
Questionnaire on stent tolerance or non-tolerance
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Volontary patient Over 18 years old or more. Complain of a nasal obstruction more important (or only) at night (in decubitus position) Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jung Camille, MD
Phone
01.57.02.22.68
Email
camille.jung@chicreteil.fr
Facility Information:
Facility Name
Centre Hospitalier Intercommunal
City
Créteil
State/Province
Ile De France
ZIP/Postal Code
94000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie BEQUIGNON
Email
emilie.bequignon@gmail.com
Facility Name
Hôpital Henri Mondor
City
Créteil
ZIP/Postal Code
94000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie BEQUIGNON
Email
emilie.bequignon@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy of an Intranasal Stent on Nasal Obstruction at Night

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