NCT00416143

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2006

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 27, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

December 27, 2006

Status Verified

December 1, 2006

First QC Date

December 24, 2006

Last Update Submit

December 24, 2006

Conditions

Sudden Loss of Hearing

Keywords

Bed rest for idiopathic sudden sensorineural hearing loss

Outcome Measures

Primary Outcomes (1)

  • hearing improvement

Interventions

bed restPROCEDURE
prednisone - oral corticosteroid 1mg/kg/D for 1 weekDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • patients with sudden sensorineural hearing loss

You may not qualify if:

  • age less than 16 years
  • contraindication for oral steroid treatment
  • prior steroid treatment for hearing loss
  • pregnent women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Bed RestFumigant 93

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Eldar Carmel, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eldar Carmel, MD

CONTACT

972-3-5302442eldarca@sheba.health.gov.il

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 24, 2006

First Posted

December 27, 2006

Study Start

June 1, 2006

Study Completion

December 1, 2008

Last Updated

December 27, 2006

Record last verified: 2006-12

Locations

IL(1)