Nasal PolyposisODORAT_IRMfNCT03979716
Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging
A study testing fMRI in people with Nasal Polyposis, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasal Polyposis
- What is being tested?
- fMRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2019to 23 Jun 2021
- 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
- Patients with nasal polyposis managed in the department of otorhinolaryngology and head and neck surgery of Nancy University Hospital,
- Adult Patients,
- Justifying a surgical treatment for nasal polyposis,
- Present hyposmia, anosmia or normosmia before surgery (confirmed by threshold and identification tests of the Sniffin' Stick kit),
- Affiliated with or beneficiary of a social security scheme,
- Having received complete information about the study and having signed an informed consent form.
Who cannot join
- General contraindications to Magnetic Resonance Imaging,
- Female of childbearing age without effective contraception,
- Persons referred in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code,
- Qualitative sense of smell disorder (cacosmia, hyperosmia, phantosmia, parosmia),
- Smell disorders with neurological, post-traumatic, or neurodegenerative origin.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Nancy
Nancy, 54000
Duc Trung NGUYEN, MD, PhD, MPH, 33383155409, dt.nguyen@chru-nancy.fr
About this study
Official title: Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life.
The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.
- Conditions
- Nasal Polyposis
- Being tested
- fMRI
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDevice
fMRI examination
| Study group | Role | What they receive |
|---|---|---|
| Anosmic patients | Experimental | Not described Receives: Device: fMRI |
| Hyposmic patients | Experimental | Not described Receives: Device: fMRI |
| Normosmic patients | Experimental | Not described Receives: Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Brain activity
Blood Oxygen Level Dependent (BOLD) measures in olfactory areas during calibrated olfactory stimuli in patients with NP whose olfactory function is clinically normal (normosmia), decreased (hyposmia) or absent (anosmia).
Measured: 6 months after the last inclusion
Secondary outcomes (1)
Functional Brain activity
Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery.
Measured: 6 months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start23 Dec 2019
- Primary completion23 Jun 2021 (estimated)
- Study completion23 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasal PolyposisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NGUYEN, Central Hospital, Nancy, France
- Investigators
- Duc Trung NGUYEN, MD, PhD, MPH, Principal investigator, University Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03979716
- Sponsor's protocol ID
- 2018-A03215-50
- Acronym
- ODORAT_IRMf
- Status last verified
- Nov 2020
- First submitted
- 23 May 2019
- Last updated
- 19 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
- ClinicalTrials.gov ID
- NCT03979716
- Acronym / sponsor ID
- ODORAT_IRMf / 2018-A03215-50
- Conditions
- Nasal Polyposis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 23 Dec 2019 (actual)
- Primary completion
- 23 Jun 2021 (estimated)
- Study completion
- 23 Jun 2021 (estimated)
- First posted
- 7 Jun 2019 (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.
Nasal polyposis (NP) is a disease affecting 4% of the population. This disease is frequently accompanied by olfactory disorders (41%-84% of patients) that affect patients' quality of life.
The aim of this study is to show brain activity differences in olfactory areas before and after surgery in each patient and between patient groups (normosmic, hyposmic and anosmic one) using functional Magnetic Resonance Imaging (fMRI). Brain activity will be measured by the intensity of brain signals and of the size of olfactory areas during olfactory stimulation before and after surgery. We suppose that fMRI could predict whether or not the patient will be able to recover smell after surgery.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anosmic patients | Experimental | Device: fMRI |
| Hyposmic patients | Experimental | Device: fMRI |
| Normosmic patients | Experimental | Device: fMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with nasal polyposis managed in the department of otorhinolaryngology and head and neck surgery of Nancy University Hospital,
- Adult Patients,
- Justifying a surgical treatment for nasal polyposis,
- Present hyposmia, anosmia or normosmia before surgery (confirmed by threshold and identification tests of the Sniffin' Stick kit),
- Affiliated with or beneficiary of a social security scheme,
Key exclusion criteria (5 listed)
- General contraindications to Magnetic Resonance Imaging,
- Female of childbearing age without effective contraception,
- Persons referred in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code,
- Qualitative sense of smell disorder (cacosmia, hyperosmia, phantosmia, parosmia),
- Smell disorders with neurological, post-traumatic, or neurodegenerative origin.
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 |
|---|---|---|
| fMRIfMRI examination | Device | Anosmic patients, Hyposmic patients, Normosmic patients |
Primary outcome
Functional Brain activity
Time frame: 6 months after the last inclusion
Blood Oxygen Level Dependent (BOLD) measures in olfactory areas during calibrated olfactory stimuli in patients with NP whose olfactory function is clinically normal (normosmia), decreased (hyposmia) or absent (anosmia).
1 secondary outcome
Functional Brain activity
Time frame: 6 months after the last inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2020.
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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.
Duc Trung NGUYEN, MD, PhD, MPH principal investigator
University Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Nasal Polyposis, run by Central Hospital, Nancy, France at 1 site 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 6 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 19 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Duc Trung NGUYEN, MD, PhD, MPH (33383155409, dt.nguyen@chru-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Brain activity (time frame: 6 months after the last inclusion). 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 19 Nov 2020.