Acute Acoustic TraumaNCT04482998
Efficacy of Various Treatments for Acute Acoustic Trauma.
An observational study of Acute Acoustic Trauma, run by Medical Corps, Israel Defense Force at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Acute Acoustic Trauma
- How many people
- 250 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Study population: Subjects that served in the IDF and sustained an acute acoustic trauma between 01.01.2010 and 15.06.2020.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Acute Acoustic Trauma
- Being tested
- No intervention - retrospective study
- Keywords
- Hyperbaric Oxygen Therapy, Acute Acoustic Trauma, Steroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - retrospective studyOther
No intervention - retrospective study
| Study group | Role | What they receive |
|---|---|---|
| Steroids only - early | treatment was initiated within 7 days of acoustic trauma. Receives: Other: No intervention - retrospective study | |
| Early combined steroid and hyperbaric oxygen therapy | treatment was initiated within 7 days of acoustic trauma. Receives: Other: No intervention - retrospective study | |
| Delayed combined steroid and hyperbaric oxygen therapy | treatment was initiated after 7 days of acoustic trauma. Receives: Other: No intervention - retrospective study | |
| Early sequential steroid followed by HBO therapy | treatment was initiated within 7 days of acoustic trauma. Receives: Other: No intervention - retrospective study | |
| Delayed sequential steroid followed by HBO therapy | treatment was initiated after 7 days of acoustic trauma. Receives: Other: No intervention - retrospective study | |
| Hyperbaric oxygen therapy only | Not described Receives: Other: No intervention - retrospective study | |
| No treatment | Not described Receives: Other: No intervention - retrospective study | |
| Steroid only - delayed | treatment was initiated after 7 days of acoustic trauma. Receives: Other: No intervention - retrospective study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing improvement
dB
Measured: until 1 year of acoustic trauma.
Secondary outcomes (2)
Tinnitus
Qualitative - subjective
Measured: until 1 year of acoustic trauma.
Otoacoustic Emissions (OAE)
dB
Measured: until 1 year of acoustic trauma.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start1 Sep 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Acoustic TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical Corps, Israel Defense Force
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoni Gutkovich, Medical Corps, Israel Defense Force
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482998
- Sponsor's protocol ID
- 2131-2020
- Status last verified
- Jul 2020
- First submitted
- 19 Jul 2020
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gutkovich YE, Manheim M, Veler R, Geva A, Tal D. Hyperbaric oxygen therapy and corticosteroids as combined treatment for acute acoustic trauma. Eur Arch Otorhinolaryngol. 2025 Jul;282(7):3489-3497. doi: 10.1007/s00405-025-09246-7. Epub 2025 Jan 25.
PubMed 39863812
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Various Treatments for Acute Acoustic Trauma in the Israeli Defense Force.
- ClinicalTrials.gov ID
- NCT04482998
- Acronym / sponsor ID
- 2131-2020
- Conditions
- Acute Acoustic Trauma
- Keywords
- Hyperbaric Oxygen Therapy, Acute Acoustic Trauma, Steroids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical Corps, Israel Defense ForceUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Steroids only - early | – | Other: No intervention - retrospective studytreatment was initiated within 7 days of acoustic trauma. |
| Early combined steroid and hyperbaric oxygen therapy | – | Other: No intervention - retrospective studytreatment was initiated within 7 days of acoustic trauma. |
| Delayed combined steroid and hyperbaric oxygen therapy | – | Other: No intervention - retrospective studytreatment was initiated after 7 days of acoustic trauma. |
| Early sequential steroid followed by HBO therapy | – | Other: No intervention - retrospective studytreatment was initiated within 7 days of acoustic trauma. |
| Delayed sequential steroid followed by HBO therapy | – | Other: No intervention - retrospective studytreatment was initiated after 7 days of acoustic trauma. |
| Hyperbaric oxygen therapy only | – | Other: No intervention - retrospective study |
| No treatment | – | Other: No intervention - retrospective study |
| Steroid only - delayed | – | Other: No intervention - retrospective studytreatment was initiated after 7 days of acoustic trauma. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Subjects that served in the IDF and sustained an acute acoustic trauma between 01.01.2010 and 15.06.2020.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - retrospective studyNo intervention - retrospective study | Other | Delayed combined steroid and hyperbaric oxygen therapy, Delayed sequential steroid followed by HBO therapy, Early combined steroid and hyperbaric oxygen therapy, Early sequential steroid followed by HBO therapy, Hyperbaric oxygen therapy only, No treatment, Steroid only - delayed, Steroids only - early |
Primary outcome
Hearing improvement
Time frame: until 1 year of acoustic trauma.
dB
2 secondary outcomes
Tinnitus
Time frame: until 1 year of acoustic trauma.
Otoacoustic Emissions (OAE)
Time frame: until 1 year of acoustic trauma.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Derived from this study: PubMed 39863812Gutkovich YE, Manheim M, Veler R, Geva A, Tal D. Hyperbaric oxygen therapy and corticosteroids as combined treatment for acute acoustic trauma. Eur Arch Otorhinolaryngol. 2025 Jul;282(7):3489-3497. doi: 10.1007/s00405-025-09246-7. Epub 2025 Jan 25.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Acoustic Trauma, run by Medical Corps, Israel Defense Force at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoni Evgeni Gutkovich, M.D/Ph.D (+972526894497, gutkovichj@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing improvement (time frame: until 1 year of acoustic trauma.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04482998, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.