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Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo

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ClinicalTrials.gov Identifier: NCT03431506
Recruitment Status : Unknown
Verified February 2018 by Eye & ENT Hospital of Fudan University.
Recruitment status was:  Recruiting
First Posted : February 13, 2018
Last Update Posted : February 13, 2018
Sponsor:
Information provided by (Responsible Party):
Eye & ENT Hospital of Fudan University

Study Description
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Brief Summary:
To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo

Condition or disease Intervention/treatment Phase
Vestibular Disorder Behavioral: Vestibular rehabilitation Not Applicable

Detailed Description:
Approximately 5-20 per 100,000 persons are afflicted with SSHL annually, and nearly 20-60% of SSHL patients complain of simultaneous vertigo.The aim of this study was to evaluate the prevalence of vestibulocochlear lesions in sudden sensorneural hearing loss(SSHL) with vertigo, as well as the role of vestibular rehabilitation in the prognosis of SSHL with vertigo.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : May 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: non-training group Behavioral: Vestibular rehabilitation
Vestibular Rehabilitation Exercises
Experimental: training group Behavioral: Vestibular rehabilitation
Vestibular Rehabilitation Exercises


Outcome Measures
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Primary Outcome Measures :
  1. Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment) [ Time Frame: before treatment ]
    Vestibular function status in SSHL with vertigo at stage 1(before treatment)


Secondary Outcome Measures :
  1. Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment) [ Time Frame: 2 weeks after treatment ]
    Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment)

  2. Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment) [ Time Frame: 2 months after treatment ]
    Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A rapid onset sensorineural hearing loss of more than 30 dB for at least three contiguous audiometric frequencies within a period of 3 days, according to standard AAO - HNS;
  2. Within 10 days from onset;
  3. Without other virus infectious disease within three months.

Exclusion Criteria:

  1. BPPV; Meniere's disease and vestibular migraine.
  2. With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
Contacts and Locations
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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): NCT03431506


Contacts
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Contact: Huawei Li, Phd &MD +86-13636423139 huaweili2000@163.com

Locations
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China, Shanghai
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China Recruiting
Shanghai, Shanghai, China, 200031
Contact: Huawei Li, Phd &MD       huaweili2000@shmu.edu.cn   
Contact: Huawei Li, Phd &MD       huaweili2000@163.com   
Sponsors and Collaborators
Eye & ENT Hospital of Fudan University
More Information
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Responsible Party: Eye & ENT Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03431506    
Other Study ID Numbers: Vestibular function in SSHL
First Posted: February 13, 2018    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vertigo
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases