Condition category
Ear, Nose and Throat
Date applied
11/08/2006
Date assigned
13/10/2006
Last edited
19/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Javad Totonchi

ORCID ID

Contact details

Daneshgah Street
Imam Hospital
ENT ward
Tabriz
0098411
Iran

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SSHL trial

Study hypothesis

Sudden Sensorineural Hearing Loss is a diagnosis typically made if there is a greater than 20 dB hearing loss over at least three frequencies on audiometric testing.

Hypothesis:
In-hospital and vigorous treatment with intravenous corticosteroid and urographin will improve the outcome of patients with a sudden sensorineural hearing loss when compared to an outpatient oral corticosteroid therapy.

Ethics approval

Approved by the Institutional Board Review and Ethics Committee, a section of Research Deputy of Faculty of Medicine at Tabriz University of Medical Sciences (TUMS).

Study design

Interventional, controlled clinical trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Sudden Sensorineural Hearing Loss

Intervention

The trial is not a randomised one, as we had two groups: those hospitalised and those managed on outpatient. Hospitalisation was made on the basis of patient's request.

Inpatient group received intravenous corticosteroid and intravenous urographin, while outpatient group received oral corticosteroid.

Intervention type

Drug

Phase

Not Specified

Drug names

Corticosteroid and urographin

Primary outcome measures

Hearing recovery as shown by pure tone average on audiogram.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2003

Overall trial end date

01/01/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged over 12 years
2. A greater than 20 dB hearing loss over at least three frequencies on audiometric testing

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. General medical condition necessitating a specific therapy
2. Incompliance to the medications

Recruitment start date

01/01/2003

Recruitment end date

01/01/2005

Locations

Countries of recruitment

Iran

Trial participating centre

Daneshgah Street
Tabriz
0098411
Iran

Sponsor information

Organisation

Tabriz University of Medical Sciences (TUMS) (Iran)

Sponsor details

Danshgah Street
Tabriz
0098411
Iran

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Tabriz University of Medical Sciences (TUMS) (Iran)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes