Efficacy of Various Treatments for Acute Acoustic Trauma.
1 other identifier
observational
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 19, 2020
CompletedFirst Posted
Study publicly available on registry
July 23, 2020
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 23, 2020
July 1, 2020
3 months
July 19, 2020
July 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hearing improvement
dB
until 1 year of acoustic trauma.
Secondary Outcomes (2)
Tinnitus
until 1 year of acoustic trauma.
Otoacoustic Emissions (OAE)
until 1 year of acoustic trauma.
Study Arms (8)
Steroids only - early
treatment was initiated within 7 days of acoustic trauma.
Early combined steroid and hyperbaric oxygen therapy
treatment was initiated within 7 days of acoustic trauma.
Delayed combined steroid and hyperbaric oxygen therapy
treatment was initiated after 7 days of acoustic trauma.
Early sequential steroid followed by HBO therapy
treatment was initiated within 7 days of acoustic trauma.
Delayed sequential steroid followed by HBO therapy
treatment was initiated after 7 days of acoustic trauma.
Hyperbaric oxygen therapy only
No treatment
Steroid only - delayed
treatment was initiated after 7 days of acoustic trauma.
Interventions
No intervention - retrospective study
Eligibility Criteria
Subjects that served in the IDF and sustained an acute acoustic trauma between 01.01.2010 and 15.06.2020.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Israeli Navy Medical Institute
Haifa, Israel
Related Publications (1)
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.
PMID: 39863812DERIVED
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- deputy of the head of department for the human performance laboratory, the Israeli naval institute, Haifa.
Study Record Dates
First Submitted
July 19, 2020
First Posted
July 23, 2020
Study Start
September 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
July 23, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share