Headache DisordersHEADSNCT07754266
Headache Ear Auditory Dizziness Sinus (HEADS) Registry
An observational study of Headache Disorders and Dizziness, run by Association of Migraine Disorders at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders, Dizziness, Vestibular Diseases
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2023to 31 Dec 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Under 18 years of age, under age of Majority. Minors are not the population of interest for the study at this time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Association of Migraine Disorders
North Kingstown, Rhode Island, 02852
Frederick Godley, MD, (401) 379-0466, registry@migrainedisorders.org
About this study
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:
Read more
- 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.
- Conditions
- Headache Disorders, Dizziness, Vestibular Diseases, Sinus Disease, Vestibular Disorder, Migraine Disorders
- Keywords
- Registries, Migraine Disorders, Ear Diseases, Paranasal Sinus Diseases, Facial Pain, Headache
- Medical subject headings
- Headache Disorders, Dizziness, Vestibular Diseases, Paranasal Sinus Diseases, Migraine Disorders, Headache, Facial Pain, Ear Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Treatment history and effectiveness collected retrospectively at baseline and prospectively through annual follow-up assessments for up to 10 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start6 Jul 2023
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- 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
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Association of Migraine Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Lumiio Inc., Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07754266
- Sponsor's protocol ID
- NB600394
- Acronym
- HEADS
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Headache Ear Auditory Dizziness Sinus (HEADS) Registry
- ClinicalTrials.gov ID
- NCT07754266
- Acronym / sponsor ID
- HEADS / NB600394
- Conditions
- Headache Disorders, Dizziness, Vestibular Diseases, Sinus Disease, Vestibular Disorder, Migraine Disorders
- Keywords
- Registries, Migraine Disorders, Ear Diseases, Paranasal Sinus Diseases, Facial Pain, Headache
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Association of Migraine DisordersUniversity, hospital or other
- Collaborators
- Lumiio Inc., Pfizer
- Study start
- 6 Jul 2023 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 10 Aug 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 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Under 18 years of age, under age of Majority. Minors are not the population of interest for the study at this time.
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
Natural history of atypical Migraine
Time frame: Historical symptom data collected at baseline and annual follow-up assessments through study completion, up to 10 years.
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.
1 secondary outcome
Patient-reported treatment effectiveness for atypical migraine symptoms (4-point effectiveness scale)
Time frame: Treatment history and effectiveness collected retrospectively at baseline and prospectively through annual follow-up assessments for up to 10 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Results publication: PubMed 40919439Kuruvilla 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.
- Individual participant dataSharing planned: No
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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.
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 Headache Disorders and Dizziness, run by Association of Migraine Disorders at 1 site in United States.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 10 Aug 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frederick Godley, MD ((401) 379-0466, registry@migrainedisorders.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural history of atypical Migraine (time frame: Historical symptom data collected at baseline and annual follow-up assessments through study completion, up to 10 years.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07754266, which also lists 1 linked publication.
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 10 Aug 2026.