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

First Received on December 24, 2006. No Changes Posted

Sponsor:	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:	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:

Genetics Home Reference related topics: nonsyndromic deafness Pendred syndrome

MedlinePlus related topics: Hearing Disorders and Deafness

Drug Information available for: Prednisone Corticosteroids

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 February 09, 2012