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Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00416143
First Posted: December 27, 2006
Last Update Posted: December 27, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00416143     History of Changes
Other Study ID Numbers: SHEBA-06-4065-EC-CTIL
First Submitted: December 24, 2006
First Posted: December 27, 2006
Last Update Posted: December 27, 2006
Last Verified: December 2006

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

Additional relevant MeSH terms:
Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Sudden
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents