Efficacy of Various Treatments for Acute Acoustic Trauma.

Efficacy of Various Treatments for Acute Acoustic Trauma in the Israeli Defense Force.

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.

Study Overview

• Status: Unknown
• Conditions: Acute Acoustic Trauma
• Intervention / Treatment: Other: No intervention - retrospective study

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel
    • Israeli Navy Medical Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects that served in the IDF and sustained an acute acoustic trauma between 01.01.2010 and 15.06.2020.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hearing improvement	dB	until 1 year of acoustic trauma.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tinnitus	Qualitative - subjective	until 1 year of acoustic trauma.
Otoacoustic Emissions (OAE)	dB	until 1 year of acoustic trauma.

Collaborators and Investigators

• Sponsor: Medical Corps, Israel Defense Force

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2020
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 19, 2020
• First Submitted That Met QC Criteria: July 19, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): July 23, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Steroids; Hyperbaric Oxygen Therapy; Acute Acoustic Trauma
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss, Sensorineural; Hearing Loss; Wounds and Injuries; Hearing Loss, Noise-Induced
• Other Study ID Numbers: 2131-2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No