Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss | NCT00416143

Studies
Bed Rest for Idiopathic Sudden Sensorineural Hearing Loss

NCT00416143

Sponsor

Sheba Medical Center

Status

Unknown status

Last Update Posted

Dec 27, 2006Estimated

Enrollment

Phase

Phase 2Phase 3

Conditions

Sudden Loss of Hearing

Interventions

bed rest
prednisone - oral corticosteroid 1mg/kg/D for 1 week

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Dec 2008

First Submitted Date

Dec 24, 2006

First Submission Date that Met QC Criteria

Dec 24, 2006

First Posted Date

Dec 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 24, 2006

Last Update Posted Date

Dec 27, 2006Estimated

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Measure	Description	Time Frame
hearing improvement

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eldar Carmel, MD	Contact	972-3-5302442		eldarca@sheba.health.gov.il

Overall Officials

Name	Affiliation	Role
Eldar Carmel, MD	Sheba Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sheba Medical Center	Recruiting	Tel Litwinsky			Israel

Condition Browse Module

MeSH Terms

ID	Term
D003639	Hearing Loss, Sudden

Ancestor Terms

ID	Term
D034381	Hearing Loss
D006311	Hearing Disorders
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001510	Bed Rest
C007792	Fumigant 93

Ancestor Terms

ID	Term
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
bed rest	Procedure
prednisone - oral corticosteroid 1mg/kg/D for 1 week	Drug