Treatment of sudden idiopathic deafness with hyperbaric oxygen-therapy and intramuscular injection of CDP-choline. - Therapy of sudden deafness with CDP-choline and hyperbaric oxygen-therapy
- Conditions
- ONEMedDRA version: 9.1Level: SOCClassification code 10013993
- Registration Number
- EUCTR2009-011556-22-IT
- Lead Sponsor
- FONDAZIONE IRCCS OSPEDALE MAGGIORE POLICLINICO MANGIAGALLI E REGINA ELENA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
odiagnosis and start of the treatment within 72 hours from onset of the symptoms
oage>18 years
opatients without severe systemic disease
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
oonset of the symptoms more than 72 hours
oage<18 years
oclaustrophobia
opsychosis
oacute otitis
opregnancy (first-quarter)
ohypertension without therapy
oepilepsy
oischemic or congestive cardiac failure
osevere pulmonary disease
oglaucoma
odetachment of the retina
opneumothorax or emphysema
otubaric dysfunction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation the number of patients that have: <br>oa full retrieval of hearing (return to previous or to normal auditory threshold) after the therapy<br>oan improvement of auditory threshold (>50%) after the therapy<br>oa failure of the therapy (<50%);Secondary Objective: None;Primary end point(s): Healing of the patients
- Secondary Outcome Measures
Name Time Method