Efficacy of Various Treatments for Acute Acoustic Trauma.

NCT ID: NCT04482998

Last Updated: 2020-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-01

Study Completion Date

2020-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Acoustic Trauma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Steroids only - early

treatment was initiated within 7 days of acoustic trauma.

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Early combined steroid and hyperbaric oxygen therapy

treatment was initiated within 7 days of acoustic trauma.

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Delayed combined steroid and hyperbaric oxygen therapy

treatment was initiated after 7 days of acoustic trauma.

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Early sequential steroid followed by HBO therapy

treatment was initiated within 7 days of acoustic trauma.

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Delayed sequential steroid followed by HBO therapy

treatment was initiated after 7 days of acoustic trauma.

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Hyperbaric oxygen therapy only

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

No treatment

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Steroid only - delayed

treatment was initiated after 7 days of acoustic trauma.

No intervention - retrospective study

Intervention Type OTHER

No intervention - retrospective study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention - retrospective study

No intervention - retrospective study

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical Corps, Israel Defense Force

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yoni Gutkovich

deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Israeli Navy Medical Institute

Haifa, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yoni Evgeni Gutkovich, M.D/Ph.D

Role: CONTACT

+972526894497

Dror Tal, Ph.D

Role: CONTACT

+972549096080

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 39863812 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2131-2020

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Role of Exposure in Hyperacusis
NCT04705246 NOT_YET_RECRUITING NA
Intervention for Reduced Sound Tolerance
NCT00890526 COMPLETED PHASE1