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

December 28, 2025 updated by: Sofia Tsanoula, National and Kapodistrian University of Athens

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

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.

Study Overview

Status

Completed

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.

Study Type

Observational

Enrollment (Actual)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece
        • Aeginition Hospital of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients visiting the Headache Outpatient Department of Eginition Hospital of Athens

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with episodic or chronic migraine with or without aura
Patients with episodic or chronic tension type headache

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline assessment over a six month period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline assessment over a six month period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National and Kapodistrian University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 8, 2024

Primary Completion (Actual)

December 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

December 28, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 28, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ΨΤΧ446Ψ8Ν2-4Β5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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