Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss - Tabular View

Tracking Information

First Received Date ^ICMJE

December 24, 2006

Last Updated Date

December 24, 2006

Start Date ^ICMJE

June 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

hearing improvement

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

Official Title ^ICMJE

Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

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

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Sudden Loss of Hearing

Intervention ^ICMJE

Procedure: bed rest
Drug: prednisone - oral corticosteroid 1mg/kg/D for 1 week

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Eldar Carmel, MD

972-3-5302442

eldarca@sheba.health.gov.il

Location Countries ^ICMJE

Israel

Administrative Information

NCT ID ^ICMJE

NCT00416143

Responsible Party

Study ID Numbers ^ICMJE

SHEBA-06-4065-EC-CTIL

Study Sponsor ^ICMJE

Sheba Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Eldar Carmel, MD

Sheba Medical Center

Information Provided By

Sheba Medical Center

Verification Date

December 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP