Idiopathic sudden sensorineural hearing loss (ISSNHL)
Conditions
Interventions
Trade Name: Hyperbaric oxgyen
Pharmaceutical Form: Medicinal gas, compressed
Sponsors
Helse-Bergen HF, Haukeland University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 Objective: - 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 ;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 ;Timepoint(s) of evaluation of this end point: week 14. (Values at week 14 will be corrected for values at day 1) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) ;Timepoint(s) of evaluation of this end point: efficacy-related endpoints: 14 weeks safety-related endpoints: all visits | — |
Countries
Norway
Contacts
Public ContactDepartment of Occupational Medicine
Hels-Bergen HF, Haukeland University Hospital
Outcome results
None listed