Efficacy of Hyperbaric oxygen in addition to standard treatment for acute sudden deafness
A legfontosabb adatok
- Fázis
- 2/3. fázis
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Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Helse Bergen HF
- Azonosító
- EU 2024-510798-84-00
- A regiszteradat frissítve
- 2026. november 6.
- Eredeti leírás
To assess if the addition of HBOT to standard care leads to better hearing 3 months after treatment than treatment with standard care only.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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).
Kizáró feltételek: 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.