MigraineNCT07329127
The Prevalence of Osmophobia in Migraine and Tension-Type Headache Patients and Its Association With Migraine Symptoms Over a Period of 6 Months
An observational study of Migraine and Tension Headache, run by National and Kapodistrian University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Migraine, Tension Headache
- How many people
- 210 participants
- Where
- 1 siteGreece
- Study dates
- 8 Jan 2024to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients visiting the Headache Outpatient Department of Eginition Hospital of Athens
Who may be able to join
- 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
Who cannot join
- Patients with primary or secondary anosmia
- Inability to obtain written consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Keywords
- migraine, osmophobia, Predictive markers, sensory hypersensitivity, diagnostic criteria
- Medical subject headings
- Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with episodic or chronic migraine with or without aura | Not described | |
| Patients with episodic or chronic tension type headache | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of osmophobia in migraine and tension-type headache
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
Measured: At baseline assessment over a six month period
Secondary outcomes (1)
The correlation of osmophobia with headache type and symptoms and the calculation of its sensitivity and specificity
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.
Measured: At baseline assessment over a six month period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start8 Jan 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by National and Kapodistrian University of AthensThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- National and Kapodistrian University of Athens
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofia Tsanoula, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07329127
- Sponsor's protocol ID
- ΨΤΧ446Ψ8Ν2-4Β5
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osmophobia Is Likely the Best Phenotypic Indicator of Migraine: A Prospective, Non-Interventional, 6-Month Longitudinal Study
- ClinicalTrials.gov ID
- NCT07329127
- Acronym / sponsor ID
- ΨΤΧ446Ψ8Ν2-4Β5
- Conditions
- Migraine, Tension Headache
- Keywords
- migraine, osmophobia, Predictive markers, sensory hypersensitivity, diagnostic criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- National and Kapodistrian University of AthensUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with episodic or chronic migraine with or without aura | – | – |
| Patients with episodic or chronic tension type headache | – | – |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients visiting the Headache Outpatient Department of Eginition Hospital of Athens
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with primary or secondary anosmia
- Inability to obtain written consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Tension Headache, run by National and Kapodistrian University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of osmophobia in migraine and tension-type headache (time frame: At baseline assessment over a six month period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.