Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
Primary Purpose
Sudden Loss of Hearing
Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
bed rest
prednisone - oral corticosteroid 1mg/kg/D for 1 week
Sponsored by
About this trial
This is an interventional treatment trial for Sudden Loss of Hearing focused on measuring Bed rest for idiopathic sudden sensorineural hearing loss
Eligibility Criteria
Inclusion Criteria:
- patients with sudden sensorineural hearing loss
Exclusion Criteria:
- age less than 16 years
- contraindication for oral steroid treatment
- prior steroid treatment for hearing loss
- pregnent women
Sites / Locations
- Sheba Medical CenterRecruiting
Outcomes
Primary Outcome Measures
hearing improvement
Secondary Outcome Measures
Full Information
NCT ID
NCT00416143
First Posted
December 24, 2006
Last Updated
December 24, 2006
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00416143
Brief Title
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
Official Title
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
5. Study Description
Brief Summary
sudden sensorineural hearing loss:
idiopathic in most cases
5-20/100,000 new cases annually in the U.S
no establishes pathogenesis
treated with oral steroids in most cases
~50% improvement in hearing levels
bed rest - acceptable treatment, not well investigated
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sudden Loss of Hearing
Keywords
Bed rest for idiopathic sudden sensorineural hearing loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
bed rest
Intervention Type
Drug
Intervention Name(s)
prednisone - oral corticosteroid 1mg/kg/D for 1 week
Primary Outcome Measure Information:
Title
hearing improvement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with sudden sensorineural hearing loss
Exclusion Criteria:
age less than 16 years
contraindication for oral steroid treatment
prior steroid treatment for hearing loss
pregnent women
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eldar Carmel, MD
Phone
972-3-5302442
Email
eldarca@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eldar Carmel, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center
City
Tel Hashomer
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eldar Carmel, MD
Phone
972-3-5302442
Email
eldarca@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Eldar Carmel, MD
12. IPD Sharing Statement
Learn more about this trial
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
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