Headache Ear Auditory Dizziness Sinus (HEADS) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Natural history of atypical Migraine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •Under 18 years of age, under age of Majority. Minors are not the population of interest for the study at this time.
结局指标
主要结局
Natural history of atypical Migraine
时间窗: 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.
次要结局
- 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.)