Efficacy of Various Treatments for Acute Acoustic Trauma.

• Conditions: Acute Acoustic Trauma
• Interventions: Other: No intervention - retrospective study

• Registration Number: NCT04482998
• Lead Sponsor: Medical Corps, Israel Defense Force

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-07
• Study First Submitted: 2020-07-19
• Study First Submitted QC: 2020-07-19
• Last Update Submitted: 2020-07-19
• Study First Posted: 2020-07-23
• Last Update Posted: 2020-07-23
• Study Start: 2020-09-01
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Delayed sequential steroid followed by HBO therapy	No intervention - retrospective study	treatment was initiated after 7 days of acoustic trauma.
Early sequential steroid followed by HBO therapy	No intervention - retrospective study	treatment was initiated within 7 days of acoustic trauma.
Steroids only - early	No intervention - retrospective study	treatment was initiated within 7 days of acoustic trauma.
Hyperbaric oxygen therapy only	No intervention - retrospective study	-
No treatment	No intervention - retrospective study	-
Steroid only - delayed	No intervention - retrospective study	treatment was initiated after 7 days of acoustic trauma.
Delayed combined steroid and hyperbaric oxygen therapy	No intervention - retrospective study	treatment was initiated after 7 days of acoustic trauma.
Early combined steroid and hyperbaric oxygen therapy	No intervention - retrospective study	treatment was initiated within 7 days of acoustic trauma.

Primary Outcome Measures

Name	Time	Method
Hearing improvement	until 1 year of acoustic trauma.	dB

Secondary Outcome Measures

Name	Time	Method
Tinnitus	until 1 year of acoustic trauma.	Qualitative - subjective
Otoacoustic Emissions (OAE)	until 1 year of acoustic trauma.	dB

Trial Locations

Locations (1)

Israeli Navy Medical Institute; 🇮🇱 Haifa, Israel