Trial Review

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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.
Scientific title
Hyperbaric oxygen as salvage treatment for idiopathic sudden sensorineural hearing loss. A randomized, interventional, controlled clinical trial.
Secondary ID [1] 283068 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sudden sensorineural hearing loss 289906 0
Condition category
Condition code
Ear 290272 290272 0 0
Deafness
Neurological 290292 290292 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 287784 0
Treatment: Other
Comparator / control treatment
The control group suffered from sudden sensorineural hearing loss are treated with steroids and vasodilator but refused additional treatment.
Control group
Active

Outcomes
Primary outcome [1] 290298 0
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.
Timepoint [1] 290298 0
Timepoint: at baseline and 3 months after end of intervention.
Secondary outcome [1] 304274 0
Secondary outcome 1: auditory status at each frequency according to Plontke’s equation.
Timepoint [1] 304274 0
Timepoint: at baseline and at 3 months after end of intervention.

Eligibility
Key inclusion criteria
Sudden sensorineural hearing loss; salvage therapy.
Minimum age
15 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with retrocochlear lesion, otitis media, Meniere’s disease or other peripheral vertigo, recent use of ototoxic medications.

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
25/01/2005
Actual
21/02/2005
Date of last participant enrolment
Anticipated
9/07/2012
Actual
13/08/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5330 0
Greece
State/province [1] 5330 0

Funding & Sponsors
Funding source category [1] 287831 0
University
Name [1] 287831 0
Medical School
Aristotle University of Thessaloniki
Country [1] 287831 0
Greece
Primary sponsor type
University
Name
Medical School of Aristotle University of Thessaloniki
Address
1, Stilponos Kyriakidi st.
546 36
Thessaloniki
Greece
Country
Greece
Secondary sponsor category [1] 286558 0
None
Name [1] 286558 0
Address [1] 286558 0
Country [1] 286558 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289774 0
Aristotle ethics committee
Ethics committee address [1] 289774 0
Aristotle University of Thessaloniki
Faculty of Medicine
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
Greece
Ethics committee country [1] 289774 0
Greece
Date submitted for ethics approval [1] 289774 0
Approval date [1] 289774 0
30/01/2003
Ethics approval number [1] 289774 0
638

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42350 0
Dr George Psillas
Address 42350 0
ENT Department
American Hellenic Educational Progressive Association Hospital
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
Country 42350 0
Greece
Phone 42350 0
+30 2310 994 768
Fax 42350 0
Email 42350 0
psill@otenet.gr
Contact person for public queries
Name 42351 0
Dr George Psillas
Address 42351 0
ENT Department
American Hellenic Educational Progressive Association Hospital
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
Country 42351 0
Greece
Phone 42351 0
+30 2310 994 768
Fax 42351 0
Email 42351 0
psill@otenet.gr
Contact person for scientific queries
Name 42352 0
Dr George Psillas
Address 42352 0
ENT Department
American Hellenic Educational Progressive Association Hospital
1, Stilponos Kyriakidi st.
546 36 Thessaloniki
Country 42352 0
Greece
Phone 42352 0
+30 2310 994 768
Fax 42352 0
Email 42352 0
psill@otenet.gr

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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