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Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00416143
First received: December 24, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00416143     History of Changes
Other Study ID Numbers: SHEBA-06-4065-EC-CTIL
Study First Received: December 24, 2006
Last Updated: December 24, 2006
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:
Hearing Loss
Deafness
Hearing Loss, Sudden
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
 Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013