Cochlear implant patients in whom a cochlear implant preserving residual hearing is medically indicated H90
Conditions
Interventions
Group 1: Verum-Group: Intake over 105-106 days, 3 capsules twice a day, to be taken orally
Composition of ACEMg:
Vitamin E Acetate, EV Substance Code SUB35355, 44,5 mg
Beta-Carotene, EV-Substance Code SUB22485, 3,0mg
Ascorbis Acid, EV-Substance Code SUB3009MIG, 83,33 mg
Magnesium, EV-Substa
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 2. Intended to receive a hearing or structure preservation cochlear implant 3. Residual hearing less or equal than 85 dB HL at 125 Hz, 90 dB HL at 250 Hz and 95 dB HL at 500 Hz in the ear to be implanted at last routine appointment 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 vitamin preparations containing vitamin A, C or E or magnesium during the course of the study, and beginning at least 24 hours prior to first intake of the study medication
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation 2. Additional handicaps that would prevent participation in evaluations 3. Pre-existing conditions: 3.1 hepatopathy 3.2 severe renal insufficiency 3.3 disposition to kidney stones 3.4 iron-storage disease (thalassemia, hemochromatosis, sideroblastic anemia) 3.5 co-medication with vitamin K-antagonists 3.6 heavy smoking (= 10 cigarettes per day) 4. Current participation in any other interventional study and/or participation in another interventional study within 30 days before the study begins
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hearing loss at the implanted ear at 500 Hz 3 months post First Fitting (hearing loss = 3 months post First Fitting threshold minus 1-2 days pre-operatively threshold) measured by air conducted pure tone audiometry in ACEMg individuals compared to placebo controls. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Hearing loss at the implanted ear measured by pure tone audiometry at 500 Hz day 1 of First Fitting and 6 months post First Fitting 2. Hearing loss measured by pure tone audiometry for 125 and 250 Hz over time (day 1 of First Fitting, months 3 and 6 post First Fitting) 3. Speech perception by OLSA, month 6 after First Fitting 4. Impedances at all time points (First Fitting day 1 and day 3, month 3 and month 6 after First Fitting) Safety Endpoints: 1) All SAEs 2) All AEs | — |
Countries
Germany
Contacts
Public ContactVerena Scheper
Medizinische Hochschule Hannover Klinik für Hals-, Nasen-, Ohrenheilkunde
Outcome results
None listed