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RecruitingNCT07754266HEADSUpdated Aug 10, 2026

Headache Ear Auditory Dizziness Sinus (HEADS) Registry

An observational study in Headache Disorders, Dizziness and Vestibular Diseases, sponsored by Association of Migraine Disorders. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-10.

Primary conditionMigraine DisordersRegistry: Headache DisordersReclassifiedWhy we changed it
Registry
Headache Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Migraine Disorders
Why
  1. The study's listed conditions name Migraine Disorders, a narrower term within Headache Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Association of Migraine Disorders · Observational

From the registry’s dates

  • Started Jul 2023; still recruiting 3 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study summary

The Headache, Ear, Auditory, Dizziness, Sinus (HEADS) Registry is a study over time of individuals living in the United States who experience sinus, vestibular, auditory, and headache symptoms. Through an online portal, participants are asked questions about their symptoms, how they have affected their lives, and how effectively they have managed them. This information is then used to better understand these symptoms and to improve patient diagnosis and treatment.

Some potential research benefits of the HEADS Registry include:

  • Improving healthcare professionals' understanding of the causes of specific head and neck symptoms.
  • Reducing delays in diagnosis and the use of inappropriate tests, medications, and surgeries.
  • Finding the most effective treatments for sinus, vestibular, and auditory disorders.
  • Providing participants the opportunity to be contacted for additional important research related to sinus, vestibular, and auditory disorders.

All U.S. residents over the age of majority who experience sinus, vestibular, and auditory symptoms, with or without migraine, are eligible to participate. Enrollment is voluntary, confidential, and free of charge.

Read the detailed description

The Headache, Ear, Auditory, Dizziness, Sinus (HEADS) Registry aims to improve the lives of individuals living with atypical presentations of migraine disease. The lack of knowledge about atypical presentation of non-headache migraine symptoms presents barriers to care delivery. Single-center studies are unlikely to provide adequate sample sizes to evaluate the wide range of symptoms and treatment variables in this study.

As a decentralized data collection system, sourcing information from both registrants and their medical records provides an opportunity to include an unusually diverse population. This registry is designed with one-year updates from participants to track the natural history of these symptoms and aims to identify important prognostic markers.

The registry will collect data to adequately power observational studies, help identify patients for clinical trials, and provide a platform for post-marketing surveillance for approved therapies. Patients who are the age of majority and experiencing sinus (facial pain or pressure, nasal congestion, abnormal nasal secretions, or abnormal smell), vestibular (dizziness), auditory (ear pain or pressure, fluctuating or sudden hearing loss, hypersensitivity to noise, tinnitus, or difficulty understanding conversations), or headaches are eligible to participate in the registry.

The HEADS Registry will document the natural history (the onset, evolution, and resolution) of symptoms, with particular attention to vestibular and sinus-related symptoms and their relation to migraine headaches over time. The study consists of a baseline questionnaire as well as annual follow-up questionnaires to follow patients prospectively and continue to collect data that meets the needs of the community.

02

Conditions studied

  • Headache Disorders
  • Dizziness
  • Vestibular Diseases
  • Sinus Disease
  • Vestibular Disorder
  • Migraine Disorders
  • Headache
  • Migraine
  • Facial Pain

Keywords

  • Registries
  • Migraine Disorders
  • Ear Diseases
  • Paranasal Sinus Diseases
  • Facial Pain
  • Headache
03

In context

Migraine Disorders Reclassified

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 137 across 331 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Association of Migraine Disorders is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Compared within Migraine Disorders, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Headache Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study is inclusive of all adult Americans experiencing sinus, vestibular auditory, and/or headache symptoms, with and without a diagnosis of migraine.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Resident of the United States of America
  • Age of Majority (18+ in 47 states and Washington, D.C., 19+ in Alabama and Nebraska, 21+ in Puerto Rico and Mississippi)
  • Fluent in English OR Spanish.
  • Experience sinus, vestibular auditory, and/or headache symptoms, with and without diagnosis of migraine.

Exclusion criteria

Exclusion Criteria:

  • Under 18 years of age, under age of Majority. Minors are not the population of interest for the study at this time.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Natural history of atypical Migraine

    Document the natural history (the onset, evolution, and resolution) of atypical migraine symptoms, with particular attention to vestibular and sinus-related symptoms and their relation to migraine headaches over time.

    Time frame: Historical symptom data collected at baseline and annual follow-up assessments through study completion, up to 10 years.

Secondary outcomes

  1. Patient-reported treatment effectiveness for atypical migraine symptoms (4-point effectiveness scale)

    Patient-reported effectiveness of medications, supplements, and complementary treatments for atypical presentations of migraine disease, including vestibular, auditory, sinus-related, facial pain, and headache symptoms. Treatment effectiveness is assessed using a 4-point ordinal scale ranging from "Not effective at all" to "Extremely effective." Participants also report which symptoms improved or resolved with treatment.

    Time frame: Treatment history and effectiveness collected retrospectively at baseline and prospectively through annual follow-up assessments for up to 10 years.

07

Study locations

1 of 1 sites recruiting
  • Association of Migraine Disorders
    North Kingstown, Rhode Island 02852, United States
    Recruiting
08

References and documents

Publications

  • Kuruvilla DE, Tietjen GE, Panza GA, Hodgkinson VL, Godley FA 3rd. Facial/sinus pain or pressure and migraine: exploratory findings from the HEADS registry. Front Pain Res (Lausanne). 2025 Aug 21;6:1625442. doi: 10.3389/fpain.2025.1625442. eCollection 2025. PubMed 40919439 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07754266
Lead sponsor
Association of Migraine Disorders
Collaborators
Lumiio Inc., Pfizer
Responsible party
Sponsor
First posted
Aug 10, 2026
Start date
Jul 6, 2023
Primary completion
Dec 31, 2033 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Aug 10, 2026

Study contacts

Frederick Godley, MD
Contact
registry@migrainedisorders.org
(401) 379-0466

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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