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Enlarged Vestibular Aqueduct Registry (EVAR)

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ClinicalTrials.gov Identifier: NCT02798783
Recruitment Status : Recruiting
First Posted : June 14, 2016
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Todd Otteson, MD, MPH, FAAP, FACS, University Hospitals Cleveland Medical Center

Brief Summary:

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


Condition or disease
Enlarged Vestibular Aqueduct Sensorineural Hearing Loss

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Enlarged Vestibular Aqueduct Patient Registry at University Hospitals Rainbow Babies and Children's Hospital
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Group/Cohort
Diagnosed with EVA
Self-reported Enlarged Vestibular Aqueduct (EVA), or, when available, radiological diagnosis of EVA will be used to define the cohort.



Primary Outcome Measures :
  1. Self-reported lifelong hearing loss progression, subjectively as a questionnaire response and as hearing thresholds (dB) change in clinical documentation. [ Time Frame: 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)


Secondary Outcome Measures :
  1. Age in years at diagnosis of hearing loss, subjectively as a questionnaire response and in clinical documentation. [ Time Frame: Through study completion, an average of one year ]
    Participants will be asked about age at which hearing loss occurred and corroborated by clinical documentation of hearing loss.

  2. Age in years at first CT or MRI used to diagnose Enlarged Vestibular Aqueduct, subjectively as a questionnaire response and in clinical documentation. [ Time Frame: Through study completion, an average of one year ]
    Patients will be asked to specify the age and type of imaging used to diagnose EVA. Participant medical charts and clinical documents (e.g. radiological imaging impressions) will be used to evaluate the presence of EVA and diameter of the vestibular aqueduct in each affected ear.

  3. Hearing loss progression after flying on an airplane, subjectively as a questionnaire response and as hearing thresholds (dB) change in clinical documentation [ Time Frame: Within four weeks of flight travel ]
    Patients will be asked about hearing loss progression after flying on an airplane. If additional testing was done to confirm hearing loss progression, this will be recorded.

  4. Use of hearing aids, subjectively as a questionnaire response or as recorded in prior clinical documentation. [ Time Frame: Through study completion, an average of one year ]
    Participants will be asked about hearing therapies, including use of hearing aids, speech therapy, FM systems in school, and cochlear implantation. If provided, participant medical charts will also be reviewed to determine use of hearing aids.

  5. Hearing loss progression after documented head trauma, subjectively as a questionnaire response or as recorded in prior clinical documentation. [ Time Frame: Within four weeks of head trauma ]
    Participants will be asked about hearing loss progression following a documented head trauma, including the date and age of trauma. If additional testing was done to confirm hearing loss progression, this will be recorded.

  6. Family history of hearing loss, subjectively as a questionnaire response or as recorded in prior clinical documentation. [ Time Frame: Through study completion, an average of one year ]
    Patients will be asked about family history of hearing loss, including any genetic testing that has been completed.

  7. Balance problems or vertigo, subjectively as a questionnaire response or as recorded in prior clinical documentation. [ Time Frame: Through study completion, an average of one year ]
    Patients will be asked about problems they've experienced related to vertigo and balance problems, including the frequency, severity, activities that may have triggered it, age of first episode, and how long vertigo occurred after diagnosis.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 90 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study population includes those people who report having a diagnosis of Enlarged Vestibular Aqueduct. The cohort will be defined by voluntary submission of information to a website, eva.uhhospitals.org.
Criteria

Inclusion Criteria:

  • Self-reported diagnosis of Enlarged Vestibular Aqueduct OR
  • Radiological diagnosis of Enlarged Vestibular Aqueduct

Exclusion criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798783


Contacts
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Contact: Benjamin A Reinthal 7403905102 benjamin.reinthal@uhhospitals.org
Contact: Mustafa S Ascha, MS 2168445501 mustafa.ascha@uhhospitals.org

Locations
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United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44040
Contact: Benjamin A Reinthal    740-390-5102    benjamin.reinthal@uhhospitals.org   
Contact: Mustafa S Ascha, MS    2168445501    mustafa.ascha@uhhospitals.org   
Sponsors and Collaborators
Todd Otteson, MD, MPH, FAAP, FACS
Investigators
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Principal Investigator: Todd D Otteson, MD, MPH University Hospitals Cleveland Medical Center
Principal Investigator: Cliff Megerian, MD University Hospitals Cleveland Medical Center
Study Director: Benjamin A Reinthal University Hospitals Cleveland Medical Center
Study Director: Mustafa S Ascha, MS University Hospitals Cleveland Medical Center

Additional Information:
Publications:
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Responsible Party: Todd Otteson, MD, MPH, FAAP, FACS, Chief, Pediatric Otolaryngology, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02798783     History of Changes
Other Study ID Numbers: 04-16-06
First Posted: June 14, 2016    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A limited data set will be available to researchers who demonstrate IRB approval for a study that would require the use of data points collected by the Enlarged Vestibular Aqueduct Registry. This dataset will include information only in accordance with HIPAA definitions of a limited dataset, for example, excluding names and addresses. Data will be available one year after enrollment is to start, on June 2, 2017. The data may be obtained by submission of a request along with proof of investigator institutional review board approval, forms for which will be available through the registry web site.
Time Frame: Data will be available one year after enrollment is to start, on June 2, 2017. The study would initially continue for four years, and continue based on enrollment numbers and data requests.
Access Criteria:

Background information:

  • Corresponding researcher
  • Name
  • Title
  • Institution
  • Department
  • Address
  • Contact phone number
  • Contact email address
  • Principal Investigator
  • Name
  • Title
  • Institution
  • Department
  • Address
  • Contact phone number
  • Contact email address
  • Origin of the protocol (e.g. investigator-initiated, industry, federal agency, cooperative group, other)

Study information:

  • Full title of study
  • Whether the research has IRB approval
  • Background/rationale/significance
  • Purpose/Hypothesis

Document Upload:

  • Approved IRB Protocol Application
  • Signed CV for each investigator listed on the IRB application
  • Signed Data Use Agreement
Keywords provided by Todd Otteson, MD, MPH, FAAP, FACS, University Hospitals Cleveland Medical Center:
Vestibular Aqueduct
SLC26A4
FOXI1
Temporal Bone
Additional relevant MeSH terms:
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Hearing Loss
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms