Overview
Sponsor-declared trial summary
Acute acoustic trauma
The aim of this study is to investigate whether HyperBaric Oxygen Therapy (HBOT) twice daily for five days is superior to HBOT once daily for 10 days in terms of absolute hearing gain
Key facts
- Sponsor
- Amsterdam UMC Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Otorhinolaryngologic Diseases [C09]
- Trial duration
- completed 31 Dec 2025
- Decision date (initial)
- 2024-10-24
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-517739-35-00
- EudraCT number
- 2020-005741-17
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this study is to investigate whether HyperBaric Oxygen Therapy (HBOT) twice daily for five days is superior to HBOT once daily for 10 days in terms of absolute hearing gain
Conditions and MedDRA coding
Acute acoustic trauma
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Diagnosed with AAT based on audiometry after high impact noise-exposure at the Department of Otorhinolaryngology, Central Military Hospital
- First visit to the Department of Otorhinolaryngology between 24 and 72 hours after the acoustic trauma.
- Age ≥ 18 years old
- Minimum hearing loss: ≥ 30 dB on one tested frequency, or ≥ 25 dB on two tested frequencies, or ≥ 20 dB on three tested frequencies. When a previous audiogram is known, then the additional hearing loss due to AAT should be minimal the above
Exclusion criteria 7
- Subject does not speak fluent Dutch
- History of idiopathic sudden sensorineural loss
- History of radiation therapy in the head and neck region
- Previous acute acoustic trauma (before current trauma) with objectified hearing loss
- Current or previous use of ototoxic drugs with objectified complaints before the current visit
- Known presence or history of vestibular schwannoma or cholesteatoma
- Current otitis media
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The absolute average hearing gain on all affected frequencies at one month of follow-up
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB14733MIG · Substance
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, COMPRESSED
- Route of administration
- INHALATION
- Max daily dose
- 100 % (V/V) percent volume/volume
- Max total dose
- 100 % (V/V) percent volume/volume
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB14733MIG · Substance
- Active substance
- Oxygen
- Pharmaceutical form
- MEDICINAL GAS, CRYOGENIC
- Route of administration
- INHALATION
- Max daily dose
- 100 % (V/V) percent volume/volume
- Max total dose
- 100 % (V/V) percent volume/volume
- Max treatment duration
- 12 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Amsterdam UMC Stichting
- Sponsor organisation
- Amsterdam UMC Stichting
- Address
- De Boelelaan 1117
- City
- Amsterdam
- Postcode
- 1081 HV
- Country
- Netherlands
Scientific contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Investigator
Public contact point
- Organisation
- Amsterdam UMC Stichting
- Contact name
- Research coordinator
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 84 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-517739-35-00 for publication | 3.0 |
| Protocol (for publication) | D1_Protocol 2024-517739-35-00 not for publication | 2 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Zuurstof Medicinaal Gasvormig SOL 100 percent vv medicinaal gas samengeperst | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Zuurstof Medicinaal Vloeibaar SOL 100 percent vv medicinaal gas cryogeen | 1 |
| Synopsis of the protocol (for publication) | D1_ NL-EN_Protocol synopsis 2024-517739-35-00 | 1 |
| Synopsis of the protocol (for publication) | D1_ NL-NL_Protocol samenvatting 2024-517739-35-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-30 | Netherlands | Acceptable 2024-10-24
|
2024-10-24 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-26 | Netherlands | Acceptable 2025-09-15
|
2025-09-15 |