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Trial registered on ANZCTR
Registration number
ACTRN12613000952741
Ethics application status
Approved
Date submitted
22/08/2013
Date registered
27/08/2013
Date last updated
27/08/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
Hyperbaric oxygen as salvage treatment for idiopathic sudden sensorineural hearing loss.
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Scientific title
Hyperbaric oxygen as salvage treatment for idiopathic sudden sensorineural hearing loss. A randomized, interventional, controlled clinical trial.
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Secondary ID [1]
283068
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nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sudden sensorineural hearing loss
289906
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Condition category
Condition code
Ear
290272
290272
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0
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Deafness
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Neurological
290292
290292
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The study group includes patients who suffered from sudden sensorineural hearing loss and showed poor response to initial intravenous steroid (under tapering dosing schedule for 10 days) and vasodilator therapy for one week; after the failure of steroid and vasodilator therapy the study group is treated with hyperbaric oxygen treatment. All these patients undergo 15 consecutive hyperbaric oxygen sessions during the week except for weekends. Hyperbaric oxygen treatment is administered once daily in a multiplace hyperbaric chamber at constant level of 2.2 atmospheric pressures (ATA). Each hyperbaric oxygen session is consisted of 2 periods of 40 minutes of 100% oxygen with a 5-minute air break. The patients breathed 100% oxygen through oral nasal masks.
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Intervention code [1]
287784
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Treatment: Other
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Comparator / control treatment
The control group suffered from sudden sensorineural hearing loss are treated with steroids and vasodilator but refused additional treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
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Primary outcome: audiological assessment using pure-tone hearing average for 250, 500, 1,000, 2,000, 4,000 and 8,000 Hz in a tonal audiogram.
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Assessment method [1]
290298
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Timepoint [1]
290298
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Timepoint: at baseline and 3 months after end of intervention.
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Secondary outcome [1]
304274
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Secondary outcome 1: auditory status at each frequency according to Plontke’s equation.
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Assessment method [1]
304274
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Timepoint [1]
304274
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Timepoint: at baseline and at 3 months after end of intervention.
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Eligibility
Key inclusion criteria
Sudden sensorineural hearing loss; salvage therapy.
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Minimum age
15
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients with retrocochlear lesion, otitis media, Meniere’s disease or other peripheral vertigo, recent use of ototoxic medications.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
25/01/2005
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Actual
21/02/2005
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Date of last participant enrolment
Anticipated
9/07/2012
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Actual
13/08/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
5330
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Greece
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State/province [1]
5330
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Funding & Sponsors
Funding source category [1]
287831
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University
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Name [1]
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Medical School
Aristotle University of Thessaloniki
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Address [1]
287831
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1, Stilponos Kyriakidi st.
546 36
Thessaloniki
Greece
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Country [1]
287831
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Greece
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Primary sponsor type
University
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Name
Medical School of Aristotle University of Thessaloniki
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Address
1, Stilponos Kyriakidi st.
546 36
Thessaloniki
Greece
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Country
Greece
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Secondary sponsor category [1]
286558
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None
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Name [1]
286558
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Address [1]
286558
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Country [1]
286558
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
289774
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Aristotle ethics committee
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Ethics committee address [1]
289774
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Aristotle University of Thessaloniki
Faculty of Medicine
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
Greece
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Ethics committee country [1]
289774
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Greece
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Date submitted for ethics approval [1]
289774
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Approval date [1]
289774
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30/01/2003
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Ethics approval number [1]
289774
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638
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Summary
Brief summary
This study enrolls 40 patients affected by sudden sensorineural hearing loss, which are divided in two groups: a) the study group, which consists of 15 patients that are treated with hyperbaric oxygen after failure of steroid and vasodilator therapy and b) the control group, in which 25 patients are initially treated with steroids and vasodilator but refused additional treatment. The hyperbaric oxygen is administered in the study group once daily for 15 sessions at a constant level of 2.2 atmospheric pressures. Pure-tone hearing average and frequency-specific thresholds are obtained 3 months after the end of treatment. The aim of the present study is to investigate the efficacy of hyperbaric oxygen therapy as a salvage treatment for patients with sudden sensorineural hearing loss after the failure of initial medical treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
42350
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Dr George Psillas
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Address
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ENT Department
American Hellenic Educational Progressive Association Hospital
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
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Country
42350
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Greece
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Phone
42350
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+30 2310 994 768
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Fax
42350
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Email
42350
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[email protected]
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Contact person for public queries
Name
42351
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Dr George Psillas
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Address
42351
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ENT Department
American Hellenic Educational Progressive Association Hospital
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
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Country
42351
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Greece
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Phone
42351
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+30 2310 994 768
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Fax
42351
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Email
42351
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[email protected]
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Contact person for scientific queries
Name
42352
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Dr George Psillas
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Address
42352
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ENT Department
American Hellenic Educational Progressive Association Hospital
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
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Country
42352
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Greece
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Phone
42352
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+30 2310 994 768
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Fax
42352
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Email
42352
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[email protected]
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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
No additional documents have been identified.
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