Cochlear implant patients in whom a cochlear implant preserving residual hearing is medically indicated MedDRA version: 14.1 Level: PT Classification code 10019245 Term: Hearing impaired System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Product Name: Soundbites®
Pharmaceutical Form: Chewable tablet
INN or Proposed INN: Vitamin E
CAS Number: 7695-91-2
Other descriptive name: VITAMIN E ACETATE
Concentration unit: mg milligram(s)
Conce
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18 years of age or older 2. No or little benefit of conventional hearing aid, defined as preoperative auditory speech understanding of less or equal 60% in Freiburger monosyllables at 65 dB SPL, best aided in the ear to be implanted 3. Residual hearing better or equal than 80 dB HL at 125 and 250 Hz and better or equal than 90 dB HL at 500 Hz in the ear to be implanted 4. Ability to understand the study procedures, possible risks and benefits, and to give informed consent 5. Informed Consent is signed 6. Patients must agree not to use daily multi-vitamins or other supplements during the course of the study, and beginning at least 48 hours prior to first intake of the study medication 7. Female patients =50 years of age at the day of inclusion who have been postmenopausal since at least 1 year OR female patients who have a negative hCG serum pregnancy test and meet one or more of the following criteria: - 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral ovariectomy with or without hysterectomy - Using proven oral, injected or implanted hormonal contraceptive methods - Intrauterine Device (IUD) or intrauterine system (IUS) - Barrier methods: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam / gel / film / cream / suppository) - Male sterilisation (if the absence of sperm in the ejaculate is documented. For female participants the vasectomized male partner should be the sole sexual partner for that subject) - True abstinence (Periodic abstinence and interruptus are not acceptable methods of contraception) - Only female sexual partners 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 177 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 123
Exclusion criteria
Exclusion criteria: Key Exclusion Criteria: 1. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array, as confirmed by medical examination and imaging (e.g. DVT) 2. Signs of retrocochlear or central origin to hearing impairment as confirmed by medical examination and imaging (e.g. DVT) 3. Medical or psychological conditions which contraindicate surgery (e.g. active middle ear infections, tympanic membrane perforation) 4. Pregnancy or lactation 5. Additional handicaps that would prevent participation in evaluations 6. Contraindications for ACEMg: 6.1 hepatopathy (transaminases or ?-GT >= 2 x ULN (Upper Limit of Normal)) 6.2 severe renal insufficiency (Serum creatinine > 2 x ULN) 6.3 disposition to kidney stones 6.4 iron-storage disease (thalassemia, hemochromatosis, sideroblastic anaemia) 6.5 co-medication with vitamin K-antagonists 6.6 heavy smoking (= 20 cigarettes per day) 7. Current participation in any other clinical trial and/or participation in another clinical trial within 30 days before the study begins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: The primary objective is to demonstrate that ACEMg is more efficacious than placebo in preserving residual hearing during cochlear implantation by comparing the hearing loss after 3 month at 500Hz in air conducted pure tone audiometry. ;Secondary Objective: Key secondary Objectives: • to investigate the drug effect over time (hearing loss in ACEMg compared to Placebo at 500Hz 6, 9 and 12 month post-operatively) • to compare ACEMg and Placebo at different frequencies of pure tone audiometry (125, 250 and 750 Hz, 1, 1,5, 2, 3, 4, 6 and 8 kHz) over time (month 3, 6, 9 and 12 post-operatively) • to compare efficacy by means of speech perception, functional hearing and impedances • to evaluate the effect of electrode length on hearing loss ;Primary end point(s): Hearing loss at the implanted ear at 500 Hz 3 months post-operatively (hearing loss = 3 months post-operatively threshold minus 1-2 days pre-operatively threshold) measured by air conducted pure tone audiometry;Timepoint(s) of evaluation of this end point: 3 months post-operatively | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Hearing loss at the implanted ear measured by pure tone audiometry at 500 Hz 6, 9 and 12 months post-operatively 2) Hearing loss measured by pure tone audiometry for other frequencies (125 and 250 Hz, 1, 2, 8 kHz) over time (month 3, 6, 9 and 12 post-operatively) 3) Speech perception by OLSA, month 12 4) Functional Hearing questionnaire NCIQ, month 3 and 12 5) Impedances [?] at all time points 6) Occurrence of Tinnitus: questionnaire at all time points Safety Endpoints: 1) All SAEs 2) All AEs leading to discontinuation of IMP intake ;Timepoint(s) of evaluation of this end point: 1) 6, 9 and 12 months post-operatively 2) 3, 6, 9 and 12 months post-operatively 3) 12 month 4) 3 and 12 month 5) all time points 6) all time points Safety Endpoints: upon first administration of the IMP(s) and ends 30 days after the last application | — |
Countries
Germany
Contacts
Public ContactDepartment of Otorhinolaryngology
Hannover Medical School
Outcome results
None listed