Headache Ear Auditory Dizziness Sinus (HEADS) Registry

NCT07754266 | Recruiting

• 1 other identifier: NB600394
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Registries; Migraine Disorders; Ear Diseases; Paranasal Sinus Diseases; Facial Pain; Headache

Outcome Measures

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.

  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)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Association of Migraine Disorders: lead
• Lumiio Inc.: collaborator
• Pfizer: collaborator

Study Sites (1)

Association of Migraine Disorders

North Kingstown, Rhode Island, 02852, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40919439 RESULT

MeSH Terms

Conditions

Headache Disorders; Dizziness; Vestibular Diseases; Paranasal Sinus Diseases; Migraine Disorders; Headache; Facial Pain; Ear Diseases

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Labyrinth Diseases; Otorhinolaryngologic Diseases; Nose Diseases; Respiratory Tract Diseases; Headache Disorders, Primary; Pain

Central Study Contacts

Frederick Godley, MD

CONTACT

(401) 379-0466; registry@migrainedisorders.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 10, 2026
• Study Start: July 6, 2023
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2033
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)