Nasal ObstructionRHINASTENTNCT04228016
Efficacy of an Intranasal Stent on Nasal Obstruction at Night
A study testing Device: nastent™ in people with Nasal Obstruction, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Device: nastent™
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Sep 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volontary patient
- Over 18 years old or more.
- Complain of a nasal obstruction more important (or only) at night (in decubitus position)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Not yet recruiting
Hôpital Henri Mondor
Créteil, 94000
Emilie BEQUIGNON, emilie.bequignon@gmail.com
- Recruiting
Centre Hospitalier Intercommunal
Créteil, Île-de-France Region, 94000
Emilie BEQUIGNON, emilie.bequignon@gmail.com
About this study
Official title: Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study
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.
Read the 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 .
- Conditions
- Nasal Obstruction
- Being tested
- Device: nastent™
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Device: nastent™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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Device : nasal airway stent | Experimental | All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus. Receives: Device: Device: nastent™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 15
Secondary outcomes (7)
Nasal Obstruction and Septoplasty Effectiveness (NOSE)
Scale [0-100] The higher the score, the more the quality of life is impaired.
Measured: Day 15
Analog visual scale (EVA) of nocturnal nasal obstruction
Scale [0-10] The higher the score, the stronger the feeling of nasal obstruction.
Measured: Day 15
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
Measured: Day 15
Epworth Sleepiness Scale (ESS)
Scale [0-24] The higher the score, the more the quality of life is impaired.
Measured: Day 15
Compliance
Questionnaire on the use or non-use of the stent
Measured: Day 15
Stent satisfaction
Number of patients satisfied with the stent
Measured: Day 15
Stent tolerance
Questionnaire on stent tolerance or non-tolerance
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start27 Sep 2019
- Primary completion30 Sep 2022
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Seven Dreamers Europe SAS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228016
- Sponsor's protocol ID
- RHINASTENT
- Acronym
- RHINASTENT
- Status last verified
- Mar 2023
- First submitted
- 10 Jan 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of an Intranasal Stent on Nasal Obstruction at Night: A Prospective Multicenter Study
- ClinicalTrials.gov ID
- NCT04228016
- Acronym / sponsor ID
- RHINASTENT / RHINASTENT
- Conditions
- Nasal Obstruction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Seven Dreamers Europe SAS
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental: Device : nasal airway stent | Experimental | Device: Device: nastent™All patients consulting for predominantly nocturnal nasal obstruction who have benefited from Nasal Respiratory Functional Exploration with detection of pathological resistance in the decubitus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Volontary patient
- Over 18 years old or more.
- Complain of a nasal obstruction more important (or only) at night (in decubitus position)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental: Device : nasal airway stent |
Primary outcome
Nasal resistance in anterior rhinomanometry (sPa/ml/sec)
Time frame: Day 15
Change grom Baseline of Nasal resistance in anterior rhinomanometry. Sitting, lying in the meadow and Per stent nasal.
7 secondary outcomes
Nasal Obstruction and Septoplasty Effectiveness (NOSE)
Time frame: Day 15
Analog visual scale (EVA) of nocturnal nasal obstruction
Time frame: Day 15
Sino-Nasal Outcome Test 22 (SNOT-22) questionary
Time frame: Day 15
Epworth Sleepiness Scale (ESS)
Time frame: Day 15
Compliance
Time frame: Day 15
Stent satisfaction
Time frame: Day 15
Stent tolerance
Time frame: Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Device: nastent™ in people with Nasal Obstruction, run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Camille, MD (01.57.02.22.68, camille.jung@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal resistance in anterior rhinomanometry (sPa/ml/sec) (time frame: Day 15). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.