The hyperbaric oxygen therapy in the sudden hearing loss of unknown origi
- Conditions
- Sudden Sensorineural Hearing LossTherapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
- Registration Number
- EUCTR2013-003268-29-IT
- Lead Sponsor
- AUSL Piacenza
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
-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
-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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method