CClinicalTrials.gg
Status unknownNCT04482998Updated Jul 23, 2020

Efficacy of Various Treatments for Acute Acoustic Trauma.

An observational study in Acute Acoustic Trauma, sponsored by Medical Corps, Israel Defense Force. Status unknown at 1 site in Israel. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Medical Corps, Israel Defense Force · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
250
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Acoustic Trauma

Keywords

  • Hyperbaric Oxygen Therapy
  • Acute Acoustic Trauma
  • Steroids
03

In context

Hearing Loss, Noise-Induced

43 studies on the registry are indexed under Hearing Loss, Noise-Induced; 10 are open to participants now.

This study's planned enrollment of 250 is above the median of 225 across 12 observational studies indexed under Hearing Loss, Noise-Induced.

Browse Hearing Loss, Noise-Induced studies →

Lead sponsor

Medical Corps, Israel Defense Force is the lead sponsor of 33 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • Steroids only - early

    treatment was initiated within 7 days of acoustic trauma.

    Other: 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

  • Delayed combined steroid and hyperbaric oxygen therapy

    treatment was initiated after 7 days of acoustic trauma.

    Other: 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

  • Delayed sequential steroid followed by HBO therapy

    treatment was initiated after 7 days of acoustic trauma.

    Other: No intervention - retrospective study

  • Hyperbaric oxygen therapy only

    Other: No intervention - retrospective study

  • No treatment

    Other: No intervention - retrospective study

  • Steroid only - delayed

    treatment was initiated after 7 days of acoustic trauma.

    Other: No intervention - retrospective study

Interventions

  • OtherNo intervention - retrospective study

    No intervention - retrospective study

06

What researchers measure

Primary outcomes

  1. Hearing improvement

    dB

    Time frame: until 1 year of acoustic trauma.

Secondary outcomes

  1. Tinnitus

    Qualitative - subjective

    Time frame: until 1 year of acoustic trauma.

  2. Otoacoustic Emissions (OAE)

    dB

    Time frame: until 1 year of acoustic trauma.

07

Study locations

1 site
  • Israeli Navy Medical Institute
    Haifa, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04482998
Lead sponsor
Medical Corps, Israel Defense Force
Responsible party
Yoni Gutkovich (deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa., Medical Corps, Israel Defense Force) — Principal investigator
First posted
Jul 23, 2020
Start date
Sep 1, 2020 (estimated)
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 1, 2020 (estimated)
Last update
Jul 23, 2020

Study contacts

Yoni Evgeni Gutkovich, M.D/Ph.D
Contact
gutkovichj@gmail.com
+972526894497
Dror Tal, Ph.D
Contact
tldror1@gmail.com
+972549096080

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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