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
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