None listed
Conditions
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.
Interventions
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
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.
Sponsors
Medical School of Aristotle University of Thessaloniki
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Idiopathic sudden sensorineural hearing loss
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).
Outcome results
None listed