Sudden Sensorineural Hearing Loss
Conditions
Interventions
Trade Name: Ossigeno
Pharmaceutical Form: Gas and solvent for dispersion for injection/infusion
Sponsors
AUSL Piacenza
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age > 18 yrs - unilateral sensorineural hearing loss appeared in less than 72 hrs - hearing threshold equal or greater than 30 dB at three or more adjacent frequencies - therapy starting maximum 7 days after the symptoms appearance - signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
Exclusion criteria
Exclusion criteria: - Middle ear disease - Previous sudden hearing loss (relapsing hearing loss) - Definite diagnosis (definite viral infection, Meniere’s disease, acoustic neuroma, ototoxyc drugs, multiple sclerosys) - High embolic risk from cardiac or vascular diseases - HOT contraindications (pneumotorax, upper respiratory tract infections, seizures, chemotherapy, psycosis) - Diabetes - Gastric ulcer - Pregnancy - No informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the rate of patients who recover at least the 50% of their hearing loss after hyperbaric oxygen therapy (HOT) is given;Secondary Objective: To evaluate the rate of patients who doesn’t recover or recover partially or completely after HOT. To evaluate the quality of life in terms of auditory, tinnitus and dizziness disability after HOT. To evaluate the HOT safety;Primary end point(s): To evaluate the rate of patients who recover at least the 50% of their hearing loss after HOT. The improvement is defined as a reduction of hearing threshold average at frequencies 500-1000-2000-4000 Hz ;Timepoint(s) of evaluation of this end point: One month after therapy beginning | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: One month after therapy beginning ;Secondary end point(s): - rate of patients with total hearing loss recovery after HOT - rate of patients with partial recovery of hearing loss (25-50%) after HOT - rate of patients with no recovery after HOT - residual hearing disability (final score at Spatial Hearing Questionnaire - SHQ) - hearing disability recovery (final vs initial score difference at SHQ) - residual tinnitus disability (final score at Iowa Tinnitus Handicap Questionnaire - ITHQ) - tinnitus disability recovery (final vs initial score difference at ITHQ) - residual tinnitus loudness estimated with Visual Analog Scale (VAS) - tinnitus loudness recovery (final vs initial loudness estimated with VAS) - residual dizziness disability (final score at Dizziness Handicap Inventory - DHI) - dizziness disability recovery (final vs initial score difference at DHI) - severe therapy complications (requiring treatment’s interruption) - mild therapy complications (not requiring interruption) | — |
Countries
Italy
Contacts
Public ContactServizio Ricerca e Innovazione
Azienda USL Piacenza
Outcome results
None listed