Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo

February 11, 2018 updated by: Eye & ENT Hospital of Fudan University

Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo

To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200031
        • Recruiting
        • Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: non-training group
Behavioral: Vestibular rehabilitation
Vestibular Rehabilitation Exercises
Experimental: training group
Behavioral: Vestibular rehabilitation
Vestibular Rehabilitation Exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
before treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks after treatment
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)
2 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eye & ENT Hospital of Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

May 30, 2019

Study Completion (Anticipated)

December 30, 2019

Study Registration Dates

First Submitted

January 16, 2018

First Submitted That Met QC Criteria

February 11, 2018

First Posted (Actual)

February 13, 2018

Study Record Updates

Last Update Posted (Actual)

February 13, 2018

Last Update Submitted That Met QC Criteria

February 11, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Vestibular function in SSHL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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