The Prevalence of Osmophobia in Migraine and Tension-Type Headache Patients and Its Association With Migraine Symptoms Over a Period of 6 Months

NCT ID: NCT07329127

Last Updated: 2026-01-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2024-12-30

Brief Summary

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.

Detailed Description

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.

Conditions

Migraine; Tension Headache

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with episodic or chronic migraine with or without aura

No interventions assigned to this group

Patients with episodic or chronic tension type headache

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients with a diagnosis of migraine or tension-type headache (ICHD-3)

2. Age >16 years

3. Patients with or without medication overuse headache

4. Patients with or without prophylaxis

5. Patients with or without comorbidity with mood disorders

6. Patients will have signed informed consent to participate in the study

Exclusion Criteria

1. Patients with primary or secondary anosmia

2. Inability to obtain written consent

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National and Kapodistrian University of Athens

OTHER

Sponsor Role: lead

Responsible Party

Sofia Tsanoula

Neurology Resident, Neurology Department of Hôpitaux Universitaires de Genève, PHD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Aeginition Hospital of Athens

Athens, , Greece

Countries

Greece

Other Identifiers

ΨΤΧ446Ψ8Ν2-4Β5

Identifier Type: -

Identifier Source: org_study_id