Efficacy of Hyperbaric oxygen in addition to standard treatment for acute sudden deafness

Phase 1

• Conditions: Idiopathic sudden sensorineural hearing loss (ISSNHL); Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2021-002284-22-NO
• Lead Sponsor: Helse-Bergen HF, Haukeland University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-05
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 490

Inclusion Criteria

1.18 to 80 years of age
2. Onset of acute hearing loss no longer than 7 days ago
3.HBO can be started within 7 days from symptom onset
4. Pure tone audiometry shows sensorineural hearing loss with at least 30dB loss in three consecutive frequencies
5. Idiopathic sensorineural hearing loss is the most probable diagnosis according to clinical judgement
6. The hearing threshold is 50 dB or more in PTA (based on 0,5kHz, 1kHz, 2kHz, 4kHz)
6.Informed consent given.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 350
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1.Not idiopathic sudden sensorineural hearing loss, but another disease, injury or condition is most likely the cause of the current hearing loss.
2. Cognitive or language barriers that hamper adherence to the study protocol
3. Major alcohol abuse
3.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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified