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Clinical Trials/EUCTR2013-003268-29-IT
EUCTR2013-003268-29-IT
Active, not recruiting
Not Applicable

Hyperbaric oxygen therapy in the treatment of sudden hydiopatic sensorineural hearing loss - Hyperbaric oxygen therapy in sudden SNH

AUSL Piacenza0 sitesAugust 27, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
AUSL Piacenza
Status
Active, not recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 27, 2013
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AUSL Piacenza

Eligibility 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

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)
  • \-Gastric ulcer
  • \-Pregnancy
  • \-No informed consent

Outcomes

Primary Outcomes

Not specified

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