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Trial registered on ANZCTR


Registration number
ACTRN12616001359426
Ethics application status
Approved
Date submitted
16/09/2016
Date registered
29/09/2016
Date last updated
23/06/2021
Date data sharing statement initially provided
17/06/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effectiveness of hyperbaric oxygen therapy to the final outcome of patients with sudden sensorineural hearing loss.
Scientific title
The effectiveness of hyperbaric oxygen therapy on pure tone audiogram outcome of patients with sudden sensorineural hearing loss. A prospective, randomized, interventional, controlled clinical trial.
Secondary ID [1] 290152 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 300272 0
Condition category
Condition code
Ear 300140 300140 0 0
Deafness

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The patients who fulfill the inclusion criteria after randomization are divided into two groups. The intervention will be administered by the treating physician. The study group includes patients with sudden sensorineural hearing loss, admitted to the hospital. They receive intravenous steroids under tapering dose schedule (8mg Dexamethasone x3 for 3 days, 8mg x2 for 3 days and 8mgx1 for 3 days). They also undergo 15 daily sessions (Monday to Friday) of hyperbaric oxygen therapy in a multiplace chamber at 2.2 ATA in the urban Department of Diving and Hyperbaric Medicine. The sessions start 4 days after the onset of the steroid schedule and each one includes 2 periods of 40 min of breathing 100% oxygen through an appropriate mask checked for leaks with a 5- minute air break between the two periods.
Intervention code [1] 295903 0
Treatment: Other
Intervention code [2] 295965 0
Treatment: Drugs
Comparator / control treatment
The control group includes patients with sudden sensorineural hearing loss admitted to the hospital and treated only with intravenous steroids under tapering dose schedule (8mg Dexamethasone x3 for 3 days, 8mg x2 for 3 days and 8mgx1 for 3 days).
Control group
Active

Outcomes
Primary outcome [1] 299624 0
Pure-tone hearing average including 250, 500, 1.000, 2.000, 4.000 and 8.000 Hz using pure tone audiometry.(composite primary outcome)
Timepoint [1] 299624 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Primary outcome [2] 328017 0

Hearing status according to Siegel's criteria for 500, 1000, 2000 and 4000 Hz.
Timepoint [2] 328017 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Secondary outcome [1] 327709 0
Auditory status at frequency 250 Hz using pure tone audiometry.
Timepoint [1] 327709 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Secondary outcome [2] 327916 0
Auditory status at frequency 500 Hz using pure tone audiometry.
Timepoint [2] 327916 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Secondary outcome [3] 327917 0
Auditory status at frequency 1.000 Hz using pure tone audiometry.
Timepoint [3] 327917 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Secondary outcome [4] 327918 0
Auditory status at frequency 2.000 Hz using pure tone audiometry.
Timepoint [4] 327918 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Secondary outcome [5] 327919 0
Auditory status at frequency 4.000 Hz using pure tone audiometry.
Timepoint [5] 327919 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.
Secondary outcome [6] 327920 0
Auditory status at frequency 8.000 Hz using pure tone audiometry.
Timepoint [6] 327920 0
On day 1, day 9, day 14, day 25 and 3 months after intervention.

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 with bilateral sudden sensorineural hearing loss.
2) Patients who seek assistance after more than 7 days from the presence of symptoms.
3) Patients who have already received another treatment for sudden sensorineural hearing loss.
4) Patients with other causes of sudden sensorineural hearing loss such as autoimmune disease, Meniere disease, use of ototoxic agents, syphilis, trauma.
5) Acoustic neuroma or demyelinating disease in MRI or other lesion in the cerebellopontine angle.
6) Patients younger than 18 years old.
7) Pregnancy.
8) Contraindications to HBOT such as tension or untreated or recent pneumothorax, administration of certain drugs (Bleomycin, Cisplatin, Disulfiram, Doxorubicin), untreated epilepsy or seizures, congenital spherocytosis, upper respiratory infection, heart failure, chronic obstructive pulmonary disease, claustrophobia.
9) Glaucoma.
10) Mental disorders.
11) Middle ear disease.
12) Diabetes mellitus.
13) Difficult to treat hypertension.
14) Contraindications of steroids administration (peptic ulcer disease, osteoporosis, immunosuppression).

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)
Allocation is performed by contacting a research officer not involved in the treatment of patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computerised sequence generation ''research randomizer''. (https://www.randomizer.org/)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/10/2016
Actual
10/10/2016
Date of last participant enrolment
Anticipated
22/06/2019
Actual
21/06/2019
Date of last data collection
Anticipated
22/09/2019
Actual
23/09/2019
Sample size
Target
50
Accrual to date
Final
50
Recruitment outside Australia
Country [1] 8227 0
Greece
State/province [1] 8227 0

Funding & Sponsors
Funding source category [1] 294520 0
University
Name [1] 294520 0
Medical School of Aristotle University of Thessaloniki
Country [1] 294520 0
Greece
Primary sponsor type
University
Name
Medical School of Aristotle University of Thessaloniki
Address
1 Stilponos Kyriakidi Str
54636
Thessaloniki.
Country
Greece
Secondary sponsor category [1] 293384 0
Hospital
Name [1] 293384 0
American Hellenic Educational Progressive Association (AHEPA) hospital
Address [1] 293384 0
1 Stilponos Kiriakidi Str.
54636
Thessaloniki
Country [1] 293384 0
Greece
Secondary sponsor category [2] 299169 0
Hospital
Name [2] 299169 0
General Hospital of Thessaloniki PAPAGEORGIOU
Address [2] 299169 0
Ring Road Municipality of Pavlos Meloas Area of N. Efkarpia Thessaloniki 56403
Country [2] 299169 0
Greece

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295958 0
Aristotle ethics committee
Ethics committee address [1] 295958 0
Aristotle University of Thessaloniki
Faculty of medicine
1 Stilponos Kiriakidi Str.
54636 Thessaloniki
Ethics committee country [1] 295958 0
Greece
Date submitted for ethics approval [1] 295958 0
Approval date [1] 295958 0
23/03/2016
Ethics approval number [1] 295958 0
2/23.3.2016

Summary
Brief summary
The study will enroll 50 patients with idiopathic sudden sensorineural hearing loss. The patients wil be randomly grouped into two groups of 25 patients each. The study group will receive intravenous steroids and 15 sessions of hyperbaric oxygen treatment simultaneously. The control group will receive intravenous steroids only. Pure-tone hearing average and specific thresholds will be obtained on determined days after the intervention. The aim of the study is to compare the efficacy of hyperbaric oxygen therapy as an initial treatment for idiopathic sudden sensorineural hearing loss in addition to the standard therapy of systemic steroids.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69010 0
Dr Stamatia Dova
Address 69010 0
ENT department - American Hellenic Educational Progressive Association Hospital
1 Stilponos Kyriakidi Str.
54636
Thessaloniki
Country 69010 0
Greece
Phone 69010 0
+30 6974225179
Fax 69010 0
Email 69010 0
[email protected]
Contact person for public queries
Name 69011 0
Stamatia Dova
Address 69011 0
ENT department - American Hellenic Educational Progressive Association Hospital
1 Stilponos Kyriakidi Str.
54636
Thessaloniki
Country 69011 0
Greece
Phone 69011 0
+30 6974225179
Fax 69011 0
Email 69011 0
[email protected]
Contact person for scientific queries
Name 69012 0
Stamatia Dova
Address 69012 0
ENT department - American Hellenic Educational Progressive Association Hospital
1 Stilponos Kyriakidi Str.
54636
Thessaloniki
Country 69012 0
Greece
Phone 69012 0
+30 6974225179
Fax 69012 0
Email 69012 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data collected during the trial, after de-identification and individual participant data underlying published results only, always protecting patient's privacy
When will data be available (start and end dates)?
Beginning 3 months and ending 3 years following main results publication
Available to whom?
Only researchers who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12210Study protocol  [email protected]
12211Statistical analysis plan  [email protected]
12212Informed consent form  [email protected]
12213Ethical approval  [email protected]



Results publications and other study-related documents

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