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

Phase 2/3

Recruiting

• Conditions: Idiopathic sudden sensorineural hearing loss (ISSNHL)

• Registration Number: 2024-510798-84-00
• Lead Sponsor: Helse Bergen HF

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Posted: 2024-10-13
• Last Update Posted: 2025-05-23

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 490

Inclusion Criteria

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 Criteria

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

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

Primary Outcome Measures

Name	Time	Method
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 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

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with improvement of at least 10dB PTA from baseline to week 14		Proportion of patients with improvement of at least 10dB PTA from baseline to week 14
Mean change in PTA (dB) from baseline to week 14		Mean change in PTA (dB) from baseline to week 14
Mean word recognition score (WRS) in percentage-points at week 14 and change from baseline		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 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		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		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		RAND-12 scores at day 1 and week 14
Adverse events (AE) and serious AEs (SAE)		Adverse events (AE) and serious AEs (SAE)
Known side-effects of HBOT		Known side-effects of HBOT
Mean APHAB score at week 14		Mean APHAB score at week 14

Trial Locations

Locations (12)

Helse Stavanger HF; 🇳🇴 Stavanger, Norway

Helse Forde HF; 🇳🇴 Foerde, Norway

St. Olavs Hospital HF; 🇳🇴 Trondheim, Norway

Helse Moere Og Romsdal HF; 🇳🇴 Aalesund, Norway

Akershus University Hospital; 🇳🇴 Loerenskog, Norway

Drammen Sykehus; 🇳🇴 Drammen, Norway

Sykehuset Telemark HF; 🇳🇴 Skien, Norway

Helse Bergen HF; 🇳🇴 Bergen, Norway

Oslo University Hospital HF; 🇳🇴 Oslo, Norway

Sorlandet Sykehus HF; 🇳🇴 Kristiansand S, Norway

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Helse Stavanger HF

🇳🇴Stavanger, Norway

Natascha Wathne

Site contact

004741574083

Natascha.wathne@sus.no