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NCT Number: NCT07754266

Headache Ear Auditory Dizziness Sinus (HEADS) Registry

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.

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Key information

Conditions

Headache Disorders Brain Diseases Central Nervous System Diseases Dizziness Ear Diseases Facial Pain Headache Headache Disorders, Primary Labyrinth Diseases Migraine Migraine Disorders Nervous System Diseases Neurologic Manifestations Nose Diseases Otorhinolaryngologic Diseases Pain Paranasal Sinus Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Sensation Disorders Signs and Symptoms Sinus Disease Vestibular Diseases Vestibular Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Association of Migraine Disorders

North Kingstown, Rhode Island, 02852, United States

Location status: Recruiting

Location contact

Frederick Godley, MD

CONTACT

[email protected]

(401) 379-0466

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frederick Godley, MD

CONTACT

[email protected]

(401) 379-0466

Sponsors and collaborators

Lead sponsor

Association of Migraine Disorders

Other

Collaborators

  • Lumiio Inc.
  • Pfizer

Registry information

Acronym: HEADS

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Aug 10, 2026
Registry last updated
Aug 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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