Hyperbaric oxygen treatment added to standard care for acute idiopathic sudden sensorineural hearing loss - a multicentre randomized controlled trial

Helse Bergen HF12 sites in 1 country490 target enrollmentOctober 13, 2024

Overview

Phase: Phase 2/3
Intervention: Not specified
Conditions: Not specified
Sponsor: Helse Bergen HF
Enrollment: 490
Locations: 12
Primary Endpoint: Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz
Status: Recruiting
Last Updated: 11 months ago

To assess if the addition of HBOT to standard care leads to better hearing 3 months after treatment than treatment with standard care only.

Registry

euclinicaltrials.eu

Start Date

October 13, 2024

End Date

TBD

Last Updated

11 months ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Responsible Party

Principal Investigator

Bernd Mueller

Scientific

Helse Bergen HF

•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)

•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
•Major alcohol abuse
•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

Mean absolute pure tone average (PTA*) at week 14 *PTA=mean hearing-threshold in dB of the 4 frequencies 0,5 kHz, 1kHz, 2kHz and 4kHz

Mean change in PTA (dB) from baseline to week 14
Proportion of patients with improvement of at least 10dB PTA from baseline to week 14
Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline
Categories of hearing recovery according to Siegel's criteria at week 14
Categories of hearing-loss severity and proportion of patients with serviceable hearing according to the AAO-HNS criteria at baseline and week 14
Total score of patient reported communication problems assessed by APHAB-questionnaire at day 1 and week 14
RAND-12 scores at day 1 and week 14
Adverse events (AE) and serious AEs (SAE)
Known side-effects of HBOT
Mean APHAB score at week 14