Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

December 24, 2006 updated by: Sheba Medical Center

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Tel Hashomer, Israel
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Eldar Carmel, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
hearing improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: Eldar Carmel, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion

December 1, 2008

Study Registration Dates

First Submitted

December 24, 2006

First Submitted That Met QC Criteria

December 24, 2006

First Posted (Estimate)

December 27, 2006

Study Record Updates

Last Update Posted (Estimate)

December 27, 2006

Last Update Submitted That Met QC Criteria

December 24, 2006

Last Verified

December 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-06-4065-EC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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