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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Otorhinolaryngologic Diseases [C09]

Trial duration

28 Jan 2022 → ongoing

Decision date (initial)

2024-10-13

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Bergesen Foundation, Norway · Western Norway Regional Health Authority · Foundation Dam, Norway

External identifiers

EU CT number

2024-510798-84-00

EudraCT number

2021-002284-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

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

Secondary objectives 7

1. To compare hearing in HBOT vs. standard care only 3 months after baseline by means of different established outcome measures.
2. To assess associations between improvement in pure tone hearing and word recognition with communication problems and quality of life.
3. To assess the safety of HBOT for ISSNHL
4. To identify subgroups associated with better hearing outcome 3 months after baseline.
5. To compare quality of life in treatment groups
6. To identify prognostic and predictive factors on hearing (Exploratory objective)
7. To assess the trajectory of hearing function depending on treatment (Exploratory objective)

Conditions and MedDRA coding

Idiopathic sudden sensorineural hearing loss (ISSNHL)

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

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)

Exclusion criteria 4

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
3. Major alcohol abuse
4. 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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 10

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Bernd Mueller

Public contact point

Organisation

Helse Bergen HF

Contact name

Haukeland universitetssjykehus

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications