Enlarged Vestibular Aqueduct Patient Registry at University Hospitals Rainbow Babies and Children's Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Self-reported lifelong hearing loss progression, subjectively as a questionnaire response and as hearing thresholds (dB) change in clinical documentation.
研究概览
简要总结
People with the congenital anatomical malformation known as "Enlarged Vestibular Aqueduct" (EVA) may experience decline in hearing ability. This is an online registry to gather patient experiences with EVA, with the goal of providing future researchers with the information necessary to better evaluate and make recommendations for patients with EVA. Data will be obtained from volunteers who enroll and submit their information on a website, https://eva.uhhospitals.org, and a limited data set may be provided to researchers interested in analyzing repository data. The limited data set would not contain any identifiable information except for ages, dates such as date of diagnosis, or city/state of residence.
EVA Research Project Website: http://rainbow.org/EVAResearch
EVA Patient Registry Website: https://eva.uhhospitals.org
详细描述
Study design
The present study would employ a prospective questionnaire and retrospective chart review to develop a centralized registry of EVA patient information. The questionnaire would be administered using custom-designed software and an internet web site that uses secure information transfer protocol and encryption. Given authorization for the release of Protected Health Information (PHI), respective clinicians would be contacted for medical records that would be entered alongside corresponding self-reported data. Interested researchers will be allowed to obtain data, given their respective institution's Institutional Review Board (IRB) approval and documentation thereof. The study would initially continue for four years, and continue based on enrollment numbers and data requests.
Study procedure
Collection methods would be chosen by the participant, and can include one or both of a questionnaire and/or Authorization for the Release of PHI and relevant medical records retrieval.
Implementation of this project would involve three separate components: participant data collection and interaction, (if authorized) PHI retrieval, and data provision to interested researchers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Self-reported diagnosis of Enlarged Vestibular Aqueduct OR
- •Radiological diagnosis of Enlarged Vestibular Aqueduct
- •Exclusion criteria:
排除标准
- 未提供
结局指标
主要结局
Self-reported lifelong hearing loss progression, subjectively as a questionnaire response and as hearing thresholds (dB) change in clinical documentation.
时间窗: Through study completion, an average of one year
Patients will be asked about the progression of hearing loss, including the date and age at which hearing loss progressed. This will be clinically corroborated by evaluating hearing threshold changes via clinical documentation (e.g. audiogram, OAE, ABR)
次要结局
- Age in years at first CT or MRI used to diagnose Enlarged Vestibular Aqueduct, subjectively as a questionnaire response and in clinical documentation.(Through study completion, an average of one year)
- Hearing loss progression after flying on an airplane, subjectively as a questionnaire response and as hearing thresholds (dB) change in clinical documentation(Within four weeks of flight travel)
- Family history of hearing loss, subjectively as a questionnaire response or as recorded in prior clinical documentation.(Through study completion, an average of one year)
- Balance problems or vertigo, subjectively as a questionnaire response or as recorded in prior clinical documentation.(Through study completion, an average of one year)
- Use of hearing aids, subjectively as a questionnaire response or as recorded in prior clinical documentation.(Through study completion, an average of one year)
- Age in years at diagnosis of hearing loss, subjectively as a questionnaire response and in clinical documentation.(Through study completion, an average of one year)
- Hearing loss progression after documented head trauma, subjectively as a questionnaire response or as recorded in prior clinical documentation.(Within four weeks of head trauma)