Efficacy of Hyperbaric oxygen in addition to standard treatment for acute sudden deafness
Key facts
- Phase
- Phase 2/3
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Helse Bergen HF
- Trial code
- EU 2024-510798-84-00
- Record updated
- 6 November 2026
- Original description
To assess if the addition of HBOT to standard care leads to better hearing 3 months after treatment than treatment with standard care only.Read full original descriptionShow less
Hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss - a multicentre randomized controlled trial
To assess if the addition of HBOT to standard care leads to better hearing 3 months after treatment than treatment with standard care only.
Inclusion: 18 to 80 years of age; Onset of acute hearing loss no longer than 7 days ago; HBO can be started within 7 days from symptom onset; Pure tone audiometry shows sensorineural hearing loss with at least 30dB loss in three consecutive frequencies; Idiopathic sensorineural hearing loss is the most probable diagnosis according to clinical judgement; The hearing threshold is 50 dB or more in PTA (based on 0,5kHz, 1kHz, 2kHz, 4kHz).
Exclusion: Any contraindication to treatment with hyperbaric oxygen: - COPD, asthma or other lung disease with severely reduced lung function corresponding to GOLD III (spirometry shows FEV1 <50% of expected) - Asthma not well regulated on oral basic medication and/or with attacks within the last year - Current pneumonia or <4 weeks from complete recovery - X-ray showing emphysema-bulla or non-static atelectasis - Severe cardiac failure, instable angina, cardial infarction <6 months ago - Ongoing use of Disulfiram (Antabus ®) - Earlier treatment with Bleomycin (any time) - Artificial middle ear bones - Pregnancy; Not idiopathic sudden sensorineural hearing loss, but another disease, injury or condition is most likely the cause of the current hearing loss; Cognitive or language barriers that hamper adherence to the study protocol 3. Major; Major alcohol abuse.