E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Idiopathic sudden sensorineural hearing loss (ISSNHL) |
|
E.1.1.1 | Medical condition in easily understood language |
Sudden deafness of unknown cause |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the 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. |
|
E.2.2 | Secondary objectives of the trial |
- To assess the association of age and the severity of hearing loss with improvement of hearing after both treatments - To assess the impact of hearing levels and improvement after both treatments on communication problems and quality of life (QoL) - To assess the safety of HBOT for ISSNHL Exploratory objectives: - To assess the impact of the frequency distribution of hearing loss on the course, outcome and effect of both treatments - To assess the impact of the presence of tinnitus and vertigo on the course, outcome and effect of both treatments - To assess the impact of cardiovascular risk factors on outcome and effect of both treatments - To assess the prevalence and course of vestibular dysfunction and its correlation to characteristics and outcome of hearing loss - To examine the course of hearing improvement during the first 3 months
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
|
|
E.4 | Principal 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
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
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
|
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
week 14. (Values at week 14 will be corrected for values at day 1) |
|
E.5.2 | Secondary end point(s) |
- 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 according to the AAO-HNS criteria at baseline and week 14 - Proportion of patients that received additional treatment after end of study treatment - 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 - Numbers of adverse events (AEs) and serious AEs (SAEs) in both groups - Occurrence of known side-effects of HBOT
Exploratory Endpoints: • Categorized hearing curve characteristics at baseline according to frequencies most affected (sloping / rising / flat / other) compared to parameters of hearing function and its improvement at week 14 (pure-tone and word recognition) - Presence and severity of vertigo and tinnitus at baseline and week 14 (VAS-questionnaire, THI, DHI) - Presence of cardiovascular risk factors compared - Presence and degree of vestibular dysfunction and parameters of hearing function at baseline and week 14 - Mean PTA and change at all visits (day1, day10, day15, week 8, week 14)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
efficacy-related endpoints: 14 weeks safety-related endpoints: all visits
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
assessor-blind for audiometry, which includes the primary outcome measure |
|
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Current standard of care (currently: systemic steroids) |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 12 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |