Exploration de l'Odorat en Imagerie Par Résonance Magnétique Fonctionnelle Chez Les Patients Atteints de Polypose Nasosinusienne
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional Brain activity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Functional Brain activity
时间窗: 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).
次要结局
- Functional Brain activity(6 months after the last inclusion)
研究者
NGUYEN
Medical Doctor
Central Hospital, Nancy, France