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

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

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

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

Study placed in the following topic categories:

Prednisone
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Deafness
Otorhinolaryngologic Diseases

Hearing Loss, Sudden
Neurologic Manifestations
Sensorineural Hearing Loss
Hearing Loss, Sensorineural
Hearing Loss
Ear Diseases

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 July 02, 2009