Osmophobia Is Likely the Best Phenotypic Indicator of Migraine: A Prospective, Non-Interventional, 6-Month Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- The frequency of osmophobia in migraine and tension-type headache
研究概览
简要总结
The goal of this observational study is to learn about the frequency and diagnostic value of osmophobia, which is a sensitivity to smell, in people with migraine compared to those with tension-type headache. The main question it aims to answer is:
Does osmophobia reliably indicate a migraine rather than a tension-type headache?
Participants diagnosed with migraine or tension-type headache at the Headache Outpatient Department of Aeginition Hospital of Athens will record their headaches and any sensitivity to smells using a headache diary and a special osmophobia calendar over a period of six months. They will also complete questionnaires about migraine burden and related health conditions.
详细描述
Main research question and why it is important:
Our aim is to estimate the frequency of osmophobia in migraine and tension-type headache. The significance of the result lies in the possible use of osmophobia as a diagnostic tool in the diagnostic criteria for migraine.
-Main Report (based on the above main research question): This is a prospective, non-interventional, six-month longitudinal study in which patients visiting the headache clinic will undergo a special semi-structured interview specific to headaches, in accordance with the electronic program of the Greek Headache Society (individual, family, frequency and duration of attacks, intensity of pain), which includes the MIDAS (Migraine Disability Assessment) and HIT-6(Headache Impact Test) scales. They will be given a special headache diary and a special diary for osmophobia, which they will complete and reassess over a period of 6 months.
-Study tools: Headache diary, Specialised osmophobia diary, MIDAS(Migraine Disability Assessment), HIT-6(Headache Impact Test), BECK depression scale, Written consent form
The migraine diary includes specific information about the nature of each attack (duration, intensity, presence of aura, worsening with activity) and the presence of accompanying symptoms (nausea, vomiting, photophobia, phonophobia), while the osmophobia diary specifies the characteristics of osmophobia (intensity, duration, temporal correlation with headache, type of odors, whether or not odors cause headache). The MIDAS and HIT-6 scales determine quality of life in migraine, and the BECK scale determines mood status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of migraine or tension-type headache (ICHD-3)
- •Age >16 years
- •Patients with or without medication overuse headache
- •Patients with or without prophylaxis
- •Patients with or without comorbidity with mood disorders
- •Patients will have signed informed consent to participate in the study
排除标准
- •Patients with primary or secondary anosmia
- •Inability to obtain written consent
结局指标
主要结局
The frequency of osmophobia in migraine and tension-type headache
时间窗: At baseline assessment over a six month period
Our aim is to estimate the prevalence of osmophobia in migraine and tension type headache in order to clarify its significance as a diagnostic tool for migraine
次要结局
- The correlation of osmophobia with headache type and symptoms and the calculation of its sensitivity and specificity(At baseline assessment over a six month period)
研究者
Sofia Tsanoula
Neurology Resident, Neurology Department of Hôpitaux Universitaires de Genève, PHD Student
National and Kapodistrian University of Athens