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Trial registered on ANZCTR


Registration number
ACTRN12613001032741
Ethics application status
Approved
Date submitted
12/09/2013
Date registered
17/09/2013
Date last updated
2/12/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of the use of steroids intravenously, intratympanically or in combination in the treatment of idiopathic sudden sensorineural hearing loss.
Scientific title
The role of the use of steroids intravenously, intratympanically or in combination in the hearing rehabilitation of patients with idiopathic sudden sensorineural hearing loss. A prospective, randomized, blind, interventional, controlled clinical trial.
Secondary ID [1] 283162 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic sudden sensorineural hearing loss 290017 0
Condition category
Condition code
Ear 290400 290400 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study group will include patients who suffer from idiopathic sudden sensorineural hearing loss and fulfil the inclusion criteria. After the randomization procedure, all these patients will be divided into three groups (group A, group B, group C) in order to receive different treatment modalities. The intervention in each group will be as follows:

Group A-Arm1 (intravenous steroid use)
The patients of this group will be admitted in the hospital and will receive prednisolone intravenously. The dosage of prednisolone will be 1mg/kg of body weight once daily (in the morning) for 7 days, reduced to 0.5 mg/kg of body weight once daily (in the morning) for another 3 days. The patients will stay hospitalized for 10 days in total. After being discharged they will receive methylprednisolone orally. The dosage of methylprednisolone will be 32 mg daily for 4 days, reduced to 16 mg daily for another 3 days.. After that any treatment will be discontinued.

Group B-Arm 2 (intratympanic steroid use)
The patients of this group will not be admitted in the hospital. Instead of this, they will visit the Outpatient Clinics department on specific days in order to undergo intratympanic injections of methylprednisolone. The technique of intratympanic injection of methylprednisolone will be the following: 1 hour prior to the injection, every patient will receive orally 1 tablet that contains 500 mg of paracetamol and 1 tablet that contains 400 mg of paracetamol, 50 mg of codeine and 10 mg of caffeine. These will act as painkillers that will reduce the pain/discomfort caused by the intratympanic injection. The patient will be placed in the supine position with the head tilted 45 degrees towards the healthy ear. The solution of methylprednisolne will be placed in an insuline syringe. After that, this syringe is adapted to an 25 gauge spine needle. This needle is inserted into the middle ear through the posterior-inferior quadrant of the tympanic membrane. In this way, 0.3 to 0.5 ml of a solution that contains 62.5 mg/ml methylprednisolone are injected into the middle ear. The patient is advised to avoid swallowing and to stay in the same position for 30 min after the injection in order to allow the medication to be absorbed from the inner ear through the round window. The intratympanic injections will be performed on the following days: Day 1 (day of diagnosis), day 3, day 5, day 10.

Group C-Arm 3 (combined steroid use)
The patients of this group will be admitted in the hospital and will receive combined intravenous and intratympanic steroids as described above. During the 10 days of hospitalization each patient will receive intravenous prednisolone 1mg/kg of body weight once daily (in the morning) for 7 days, reduced to 0.5 mg/kg of body weight once daily (in the morning) for another 3 days. At the same time he/she will undergo intratympanic injection of a solution that contains 62.5 mg/ml of methylprednisolone on the days 1, 3, 5 and 10. After the discharge the patients will receive treatment orally as described above (group A). Please note that in case of complete recovery prior to the completion of the treatment, all steroids will be discontinued in all three groups. Moreover, in order to monitor the adhererence to the oral steroid treatment, each patient will be given a special form. On this form he/she will have to note down the number of the tablets of methylprednisolone 8mg that he/she will take on each one of the determined days. Moreover, he/she will have to note down the time at which each tablet was taken. This form will be returned by each patient and assessed by the investigator on day 30. The adherence to the intravenous and intratympanic treatment will be ensured by the investigator and the nursing stuff that will perform the interventions.




Intervention code [1] 287892 0
Treatment: Drugs
Comparator / control treatment
Group A is regarded as the control group. The patients of this group will be admitted in the hospital and will receive prednisolone intravenously. The dosage of prednisolone will be 1mg/kg of body weight for 7 days, reduced to 0.5 mg/kg of body weight for another 3 days. The patients will stay hospitalized for 10 days in total. After being discharged they will receive methylprednisolone peros. The dosage of methylprednisolone will be 32 mg daily Group A is regarded as the control group. The patients of this group will be admitted in the hospital and will receive prednisolone intravenously. The dosage of prednisolone will be 1mg/kg of body weight for 7 days, reduced to 0.5 mg/kg of body weight for another 3 days. The patients will stay hospitalized for 10 days in total. After being discharged they will receive methylprednisolone peros. The dosage of methylprednisolone will be 32 mg daily for 4 days reduced to 16 mg daily for another 3 days. After that any treatment will be discontinued. . After that any treatment will be discontinued.
Control group
Active

Outcomes
Primary outcome [1] 290426 0
Audiological assessment using pure tone hearing average for 250, 500, 1000, 2000, 4000 and 8000 Hz and for 500, 1000, 2000 and 4000 Hz in a tonal audiogram.
Timepoint [1] 290426 0
On day 1 (day on which the diagnosis was obtained), day 3, day 5, day 10, day 30 and day 90.
Primary outcome [2] 300391 0
Hearing status according to Siegel's criteria for 500, 1000, 2000 and 4000 Hz.
Timepoint [2] 300391 0
On day 1 (day on which the diagnosis was obtained), day 3, day 5, day 10, day 30 and day 90.
Secondary outcome [1] 304500 0
Auditory status at each frequency (250, 500, 1000, 2000, 4000 and 8000 Hz) assessed by pure tone audiometry.
Timepoint [1] 304500 0
On day 1 (day on which the diagnosis was obtained), day 3, day 5, day 10, day 30 and day 90.
Secondary outcome [2] 304501 0
Evaluation of tinnitus according to the assessment form of the Tinnitus Research Group of Japan Audiological Society, 1993.
Timepoint [2] 304501 0
On day 1, day 10 and day 90.

Eligibility
Key inclusion criteria
Idiopathic sudden sensorineural hearing loss
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Patients that seeked medical assistance after more than 14 days from the initiation of symptoms.
2) Patients with bilateral sudden sensorineural hearing loss.
3) Patients that have already received treatment for this reason.
4) Patients with known causes of sudden sensorineural hearing loss such as Meniere disease, autoimmune disease, syphilis, trauma, ototoxic agents.
5) MRI of brain and cerebellopontine angle indicative of acoustic neuroma or other retrocochlear lesion (eg demyelinating disease) that can cause sudden sensorineural hearing loss.
6) Pregnancy or breast feeding.
7) Patients younger than 18 years old.
8) History of psychic disorders.
9) History of glaucoma.
10) Active inflammation of the affected ear.
11) Tympanic membrane perforation at the side of the disease.
12) Diabetes mellitus (glucose level higher than 180 mg/ml at baseline)
13) Hypertension (systolic blood pressure higher than 180 mmHg or diastolic blood pressure higher than 110 mmHg at the baseline).
14) Contraindications for the use of steroids (peptic ulcer, osteoporosis, immune suppression).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/09/2013
Actual
25/09/2013
Date of last participant enrolment
Anticipated
Actual
2/06/2016
Date of last data collection
Anticipated
Actual
2/09/2016
Sample size
Target
75
Accrual to date
Final
102
Recruitment outside Australia
Country [1] 5397 0
Greece
State/province [1] 5397 0

Funding & Sponsors
Funding source category [1] 287917 0
University
Name [1] 287917 0
Medical School of Aristotle University of Thessaloniki
Country [1] 287917 0
Greece
Primary sponsor type
University
Name
Medical School of Aristotle University of Thessaloniki
Address
1 Stilponos Kyriakidi Str.
546 36
Thessaloniki
Country
Greece
Secondary sponsor category [1] 286645 0
Hospital
Name [1] 286645 0
Konstantopoulio General Hospital of Nea Ionia
Address [1] 286645 0
3-5 St. Olga’s Str., Nea Ionia
14233
Athens
Country [1] 286645 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289848 0
Aristotle ethics committee
Ethics committee address [1] 289848 0
Ethics committee country [1] 289848 0
Greece
Date submitted for ethics approval [1] 289848 0
Approval date [1] 289848 0
02/03/2012
Ethics approval number [1] 289848 0
12/2012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42738 0
Dr Michael Tsounis
Address 42738 0
ENT Department of American Hellenic Educational Progressive Assosciation Hospital
1 Stilponos Kyriakidi Str.
546 36
Thessaloniki
Country 42738 0
Greece
Phone 42738 0
+30 6944 221 223
Fax 42738 0
Email 42738 0
mtsounis@gmail.com
Contact person for public queries
Name 42739 0
Michael Tsounis
Address 42739 0
ENT Department of American Hellenic Educational Progressive Assosciation Hospital
1 Stilponos Kyriakidi Str.
546 36
Thessaloniki
Country 42739 0
Greece
Phone 42739 0
+30 6944 221 223
Fax 42739 0
Email 42739 0
mtsounis@gmail.com
Contact person for scientific queries
Name 42740 0
Michael Tsounis
Address 42740 0
ENT Department of American Hellenic Educational Progressive Assosciation Hospital
1 Stilponos Kyriakidi Str.
546 36
Thessaloniki
Country 42740 0
Greece
Phone 42740 0
+30 6944 221 223
Fax 42740 0
Email 42740 0
mtsounis@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSystemic, intratympanic and combined administration of steroids for sudden hearing loss. A prospective randomized multicenter trial.2018https://dx.doi.org/10.1007/s00405-017-4803-5
N.B. These documents automatically identified may not have been verified by the study sponsor.