NCT07329127

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
Last Updated

January 9, 2026

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

December 4, 2025

Last Update Submit

December 28, 2025

Conditions

Keywords

migraineosmophobiaPredictive markerssensory hypersensitivitydiagnostic criteria

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    At baseline assessment over a six month period

Study Arms (2)

Patients with episodic or chronic migraine with or without aura

Patients with episodic or chronic tension type headache

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients visiting the Headache Outpatient Department of Eginition Hospital of Athens

You may qualify if:

  • 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

You may not qualify if:

  • Patients with primary or secondary anosmia
  • Inability to obtain written consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aeginition Hospital of Athens

Athens, Greece

Location

MeSH Terms

Conditions

Migraine DisordersTension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurology Resident, Neurology Department of Hôpitaux Universitaires de Genève, PHD Student

Study Record Dates

First Submitted

December 4, 2025

First Posted

January 9, 2026

Study Start

January 8, 2024

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

January 9, 2026

Record last verified: 2025-12

Locations