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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04482998
Other study ID # 2131-2020
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2020
Est. completion date December 1, 2020

Study information

Verified date July 2020
Source Medical Corps, Israel Defense Force
Contact Yoni Evgeni Gutkovich, M.D/Ph.D
Phone +972526894497
Email gutkovichj@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Acute acoustic trauma is a growing concern in the IDF. there is currently no accepted treatment. The present retrospective study is intended to evaluate the efficacy of different treatment modalities in the IDF between 01/01/2010 and 15/06/2020.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 250
Est. completion date December 1, 2020
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- Subjects diagnosed with acute acoustic trauma.

- Hearing exam performed at least 24 hours after acute acoustic trauma.

- There was a reduction of at least 30dB in the 3,000-8,000 Hz frequency range in the first hearing exam performed.

Exclusion Criteria:

- A known hearing impairment prior to acute acoustic trauma.

- Subjects lost from follow up.

- Another diagnosis is more likely than hearing loss due to acute acoustic trauma.

Study Design


Intervention

Other:
No intervention - retrospective study
No intervention - retrospective study

Locations

Country Name City State
Israel Israeli Navy Medical Institute Haifa

Sponsors (1)

Lead Sponsor Collaborator
Medical Corps, Israel Defense Force

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hearing improvement dB until 1 year of acoustic trauma.
Secondary Tinnitus Qualitative - subjective until 1 year of acoustic trauma.
Secondary Otoacoustic Emissions (OAE) dB until 1 year of acoustic trauma.