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出境医 / 临床实验 / Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging (ODORAT_IRMf)

Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging (ODORAT_IRMf)

Study Description
Brief 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.

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.


Condition or disease Intervention/treatment Phase
Nasal Polyposis Device: fMRI Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
Actual Study Start Date : December 23, 2019
Estimated Primary Completion Date : June 23, 2021
Estimated Study Completion Date : June 23, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: Anosmic patients Device: fMRI
fMRI examination
Experimental: Hyposmic patients Device: fMRI
fMRI examination
Experimental: Normosmic patients Device: fMRI
fMRI examination
Outcome Measures
Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Functional Brain activity [ Time Frame: 6 months after the last inclusion ]
    Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Contacts
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Contact: Duc Trung NGUYEN, MD, PhD, MPH 33383155409 dt.nguyen@chru-nancy.fr
Contact: Gabriela HOSSU, PhD 33383155096 g.hossu@chru-nancy.fr

Locations
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France
CHRU de Nancy Recruiting
Nancy, France, 54000
Contact: Duc Trung NGUYEN, MD, PhD, MPH    33383155409    dt.nguyen@chru-nancy.fr   
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Duc Trung NGUYEN, MD, PhD, MPH University Hospital, Nancy, France
Tracking Information
First Submitted Date  ICMJE May 23, 2019
First Posted Date  ICMJE June 7, 2019
Last Update Posted Date November 19, 2020
Actual Study Start Date  ICMJE December 23, 2019
Estimated Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2019) 		Functional Brain activity [ Time Frame: 6 months after the last inclusion ]
Changes in Blood Oxygen Level Dependent (BOLD) measurements in olfactory areas during calibrated olfactory stimuli before and after NP surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smell Exploration in Patients With Nasal Polyposis : Study by Functional Magnetic Resonance Imaging
Official Title  ICMJE Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
Brief 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.

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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Nasal Polyposis
Intervention  ICMJE Device: fMRI
fMRI examination
Study Arms  ICMJE
  • Experimental: Anosmic patients
    Intervention: Device: fMRI
  • Experimental: Hyposmic patients
    Intervention: Device: fMRI
  • Experimental: Normosmic patients
    Intervention: Device: fMRI
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2019) 		60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 23, 2021
Estimated Primary Completion Date June 23, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Duc Trung NGUYEN, MD, PhD, MPH 33383155409 dt.nguyen@chru-nancy.fr
Contact: Gabriela HOSSU, PhD 33383155096 g.hossu@chru-nancy.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03979716
Other Study ID Numbers  ICMJE 2018-A03215-50
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NGUYEN, Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Duc Trung NGUYEN, MD, PhD, MPH University Hospital, Nancy, France
PRS Account Central Hospital, Nancy, France
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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