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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases Tension Headache Tension-Type Headache

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aeginition Hospital of Athens

Athens, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients with primary or secondary anosmia
Inability to obtain written consent

Treatment and study plan

Primary outcomes

The frequency of osmophobia in migraine and tension-type headache

Time frame: 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

Secondary outcomes

The correlation of osmophobia with headache type and symptoms and the calculation of its sensitivity and specificity

Time frame: At baseline assessment over a six month period

Our secondary aim is to estimate the correlation of osmophobia with the type and characteristics of migraine and tension-type headache, e.g. with accompanying symptoms such as nausea or vomiting, but also with comorbidities such as depression disorders. In addition, the sensitivity and specificity of osmophobia as a diagnostic criterion for migraine, as well as the sensitivity, specificity, positive and negative predictive values will be calculated for each different accompanying symptom of migraine.

Sponsors and collaborators

Lead sponsor

National and Kapodistrian University of Athens

Other

Registry information

Official study title

Osmophobia Is Likely the Best Phenotypic Indicator of Migraine: A Prospective, Non-Interventional, 6-Month Longitudinal Study

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2024
First posted: Jan 9, 2026
Registry last updated: Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed