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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
First Received: December 24, 2006   No Changes Posted
Sponsor: 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

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

Resource links provided by NLM:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome
MedlinePlus related topics: Hearing Disorders and Deafness
Drug Information available for: Prednisone
U.S. FDA Resources

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

No publications provided

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

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

Additional relevant MeSH terms:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases
Hearing Loss, Sudden
 Nervous System Diseases
Neurologic Manifestations
Hearing Loss, Sensorineural
Hearing Loss
Ear Diseases

ClinicalTrials.gov processed this record on February 08, 2010



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