Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

Sudden Loss of Hearing Clinical Trial

Official title:

Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00416143
• Other study ID #: SHEBA-06-4065-EC-CTIL
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 24, 2006
• Last updated: December 24, 2006
• Start date: June 2006
• Est. completion date: December 2008

Study information

• Verified date: December 2006
• Source: Sheba Medical Center
• Contact: Eldar Carmel, MD
• Phone: 972-3-5302442
• Email: eldarca[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden
• Sudden Loss of Hearing

Intervention

Procedure:
• bed rest

Drug:
• prednisone - oral corticosteroid 1mg/kg/D for 1 week

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hearing improvement