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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
Sheba Medical Center
About
Eligibility
Locations
Outcomes
Full info

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

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 24, 2006
Last Updated
December 24, 2006
Sponsor
Sheba Medical Center
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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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