Back to resultsVestibular Function and Vestibular Rehabilitation in SSHL With Vertigo
Primary Purpose
Vestibular Disorder
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Vestibular rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Vestibular Disorder
Eligibility Criteria
Inclusion Criteria:
- 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;
- Within 10 days from onset;
- Without other virus infectious disease within three months.
Exclusion Criteria:
- BPPV; Meniere's disease and vestibular migraine.
- With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
Sites / Locations
- Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, ChinaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
non-training group
training group
Arm Description
Outcomes
Primary Outcome Measures
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)
Vestibular function status in SSHL with vertigo at stage 1(before treatment)
Secondary Outcome Measures
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)
Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment)
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)
Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment)
Full Information
NCT ID
NCT03431506
First Posted
January 16, 2018
Last Updated
February 11, 2018
Sponsor
Eye & ENT Hospital of Fudan University
1. Study Identification
Unique Protocol Identification Number
NCT03431506
Brief Title
Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo
Official Title
Vestibular Function and Vestibular Rehabilitation in Sudden Sensorneural Hearing Loss With Vertigo
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eye & ENT Hospital of Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the vestibular function and vestibular rehabilitation in sudden sensorneural hearing loss(SSHL) with vertigo
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vestibular Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
non-training group
Arm Type
Active Comparator
Arm Title
training group
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Vestibular rehabilitation
Intervention Description
Vestibular Rehabilitation Exercises
Primary Outcome Measure Information:
Title
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 1(before treatment)
Description
Vestibular function status in SSHL with vertigo at stage 1(before treatment)
Time Frame
before treatment
Secondary Outcome Measure Information:
Title
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 weeks after treatment)
Description
Vestibular function status in SSHL with vertigo at stage 2(2 weeks after treatment)
Time Frame
2 weeks after treatment
Title
Assessment of vestibular function status by vestibular function tests in SSHL with vertigo at stage 2(2 months after treatment)
Description
Vestibular function status in SSHL with vertigo at stage 2(2 months after treatment)
Time Frame
2 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
Within 10 days from onset;
Without other virus infectious disease within three months.
Exclusion Criteria:
BPPV; Meniere's disease and vestibular migraine.
With certain Known etiology, including acoustic neuroma, heart cerebrovascular accident, injury, Hunt syndrome, etc
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huawei Li, Phd &MD
Phone
+86-13636423139
Email
huaweili2000@163.com
Facility Information:
Facility Name
Otorhinolaryngology Department of Affiliated Eye and ENT Hospital, Fudan University, Shanghai, China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huawei Li, Phd &MD
Email
huaweili2000@shmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Huawei Li, Phd &MD
Email
huaweili2000@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vestibular Function and Vestibular Rehabilitation in SSHL With Vertigo
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