Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss - Full Text View

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

ChemIDplus related topics:

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
First Received:	December 24, 2006
Last Updated:	December 24, 2006
ClinicalTrials.gov Identifier:	NCT00416143
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration