None listed
Conditions
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.
Interventions
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
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.
Sponsors
Medical School of Aristotle University of Thessaloniki
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Sudden sensorineural hearing loss; salvage therapy.
Exclusion criteria
Patients with retrocochlear lesion, otitis media, Meniere’s disease or other peripheral vertigo, recent use of ototoxic medications.
Outcome results
None listed