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Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss
This study is currently recruiting participants.
Verified by Sheba Medical Center, December 2006
Sponsored by: Sheba Medical Center
Information provided by: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00416143
  Purpose

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

Condition Intervention Phase
Sudden Loss of Hearing
 Procedure: bed rest
Drug: prednisone - oral corticosteroid 1mg/kg/D for 1 week
 Phase II
Phase III

Genetics Home Reference related topics: nonsyndromic deafness
MedlinePlus related topics: Hearing Disorders and Deafness
Drug Information available for: Prednisone Corticosteroids
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • hearing improvement

Estimated Enrollment: 60
Study Start Date: June 2006
Estimated Study Completion Date: December 2008
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416143

Contacts
Contact: Eldar Carmel, MD 972-3-5302442 eldarca@sheba.health.gov.il

Locations
Israel
Sheba Medical Center Recruiting
TEL HASHOMER, Israel
Contact: Eldar Carmel, MD     972-3-5302442     eldarca@sheba.health.gov.il    
Principal Investigator: Eldar Carmel, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: Eldar Carmel, MD Sheba Medical Center
  More Information

Study ID Numbers: SHEBA-06-4065-EC-CTIL
Study First Received: December 24, 2006
Last Updated: December 24, 2006
ClinicalTrials.gov Identifier: NCT00416143  
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
Bed rest for idiopathic sudden sensorineural hearing loss

Study placed in the following topic categories:
Prednisone
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
 Sensorineural hearing loss
Hearing Loss, Sudden
Neurologic Manifestations
Hearing Loss, Sensorineural
Hearing Loss
Ear Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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